Viewing Study NCT01584258


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Study NCT ID: NCT01584258
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-01-19
First Post: 2012-04-22
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Prostate Advances in Comparative Evidence
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011468', 'term': 'Prostatectomy'}], 'ancestors': [{'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre, international phase 3 randomised controlled study comprising three parallel randomisations with a common experimental arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2205}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2012-04-22', 'studyFirstSubmitQcDate': '2012-04-22', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PACE-B and PACE-C: Freedom from biochemical or clinical failure', 'timeFrame': '5 years from randomisation (primary timepoint)', 'description': 'Biochemical progression is defined as: Phoenix definition\n\nClinical progression is defined as: commencement (PACE-B) or re-commencement (PACE-C) of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases'}, {'measure': 'PACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother', 'timeFrame': '2 years from treatment (primary timepoint)', 'description': 'Urinary incontinence assessed by the number of absorbent pads required per day to control leakage measured by The Expanded Prostate Cancer Index (EPIC) questionnaire.\n\nBowel bother assessed by summary score from the EPIC questionnaire.'}], 'secondaryOutcomes': [{'measure': 'All arms: Clinician reported acute toxicity', 'timeFrame': '10 years', 'description': 'CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).'}, {'measure': 'All arms: Clinician reported late toxicity', 'timeFrame': '10 years', 'description': 'CTCAE and RTOG (SBRT and conventional RT patients only).'}, {'measure': 'All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms.', 'timeFrame': '10 years', 'description': 'Assessed using International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), Vaizey score, and Expanded Prostate Index Composite-26 (EPIC-26) instruments.'}, {'measure': 'All arms: Disease-specific and overall survival', 'timeFrame': '10 years', 'description': 'Disease-specific and overall survival'}, {'measure': 'All arms: Progression-free survival', 'timeFrame': '10 years', 'description': 'Radiographic, clinical or biochemical evidence of local or distant failure'}, {'measure': 'PACE-A and PACE-B: Commencement of androgen deprivation therapy; PACE-C: Re-commencement of androgen deprivation therapy', 'timeFrame': '10 years', 'description': 'LHRH analogues, anti-androgens, orchidectomy'}, {'measure': 'PACE-A: Freedom from biochemical or clinical failure', 'timeFrame': '5 years from randomisation (primary timepoint)', 'description': 'Biochemical progression is defined as: Phoenix definition (SBRT arm) or \\>0.2ng/ml (surgical arm)\n\nClinical progression is defined as: commencement of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Prostate adenocarcinoma', 'Organ-confined prostate cancer', 'Low-risk prostate cancer', 'Intermediate-risk prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '40517778', 'type': 'DERIVED', 'citation': "Tree AC, Hinder V, Chan A, Tolan S, Ostler P, van der Voet H, Kancherla K, Loblaw A, Naismith O, Jain S, Martin A, Price D, Brand D, Chu W, Duffton A, Kelly P, O'Neill B, Staffurth J, Sasso G, Pugh J, Manning G, Brown S, Burnett S, Griffin C, Hall E, van As N; PACE Investigators. Intensity-modulated moderately hypofractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-C): early toxicity results from a randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2025 Jul;26(7):936-947. doi: 10.1016/S1470-2045(25)00205-0. Epub 2025 Jun 12."}, {'pmid': '39716881', 'type': 'DERIVED', 'citation': 'Smith RP, Mohammed MA, Beriwal S, Benoit RM. Prostate Brachytherapy With Cs-131: Long-term Results Compared With Published Stereotactic Body Radiotherapy Data. Am J Clin Oncol. 2025 Jan 1;48(1):34-37. doi: 10.1097/COC.0000000000001145. Epub 2024 Oct 17.'}, {'pmid': '39413377', 'type': 'DERIVED', 'citation': 'van As N, Griffin C, Tree A, Patel J, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Camilleri P, Kancherla K, Frew J, Chan A, Naismith O, Armstrong J, Staffurth J, Martin A, Dayes I, Wells P, Price D, Williamson E, Pugh J, Manning G, Brown S, Burnett S, Hall E. Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer. N Engl J Med. 2024 Oct 17;391(15):1413-1425. doi: 10.1056/NEJMoa2403365.'}, {'pmid': '36113498', 'type': 'DERIVED', 'citation': 'Tree AC, Ostler P, van der Voet H, Chu W, Loblaw A, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Armstrong J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Duffton A, Brand DH, Henderson D, Morrison K, Brown S, Pugh J, Burnett S, Mahmud M, Hinder V, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2022 Oct;23(10):1308-1320. doi: 10.1016/S1470-2045(22)00517-4. Epub 2022 Sep 13.'}, {'pmid': '31540791', 'type': 'DERIVED', 'citation': 'Brand DH, Tree AC, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Henderson D, Brown S, Cruickshank C, Burnett S, Duffton A, Griffin C, Hinder V, Morrison K, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2019 Nov;20(11):1531-1543. doi: 10.1016/S1470-2045(19)30569-8. Epub 2019 Sep 17.'}], 'seeAlsoLinks': [{'url': 'https://www.icr.ac.uk/our-research/centres-and-collaborations/centres-at-the-icr/clinical-trials-and-statistics-unit/clinical-trials/pace', 'label': 'ICR Clinical Trials Unit - PACE website'}, {'url': 'https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-surgery-conventional-radiotherapy-and-stereotactic-radiotherapy-for-localised-prostate-cancer-pace', 'label': 'Cancer Research UK- PACE'}]}, 'descriptionModule': {'briefSummary': 'This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion critieria (all arms):\n\n* Histological confirmation of prostate adenocarcinoma within the last 18 months (unless on active surveillance and not clinically indicated)\n* Men aged ≥18 years at randomisation\n* WHO performance status 0 - 2\n* Patients considered candidates for surgery are eligible for PACE-A; patients not considered candidates for surgery and patients who decline surgery or prefer to avoid surgery are eligible for PACE-B and PACE-C.\n* Ability of the research subject to understand and the willingness to sign a written informed consent document.\n\nSpecific risk stratification inclusion criteria for PACE-A and PACE-B:\n\n* Minimum of 10 biopsy cores.\n* Gleason score ≤ 3+4\n* Clinical and/or MRI stage T1c -T2c, N0-X, M0-X\n* PSA ≤ 20 ng/ml (completed within 60 days of randomisation)\n* Patients belonging to one of the following risk groups:\n* Low risk - patients with tumours meeting all of the following criteria:\n\n * Gleason ≤ 6\n * Clinical stage T1-T2a\n * PSA \\< 10 ng/ml (within 60 days prior to randomisation)\n* Intermediate risk - patients with tumours meeting any one of the following criteria:\n\n * Gleason 3+4\n * Clinical stage T2b or T2c\n * PSA 10-20 ng/ml (within 60 days prior to randomisation)\n\nSpecific risk stratification inclusion criteria for PACE-C:\n\n* Patient planned for a minimum of 6 months ADT (maximum of 12 months). Patients receiving extended androgen deprivation therapy (18 months maximum) to permit safe delay of radiotherapy as a result of the COVID19 pandemic (only) are eligible.\n* Gleason score ≤ 4+4\n* MRI stage T1c -T3a, N0-X, M0-X\n* PSA ≤ 30 ng/ml (within 60 days prior to starting ADT)\n* Patients belonging to one of the following risk groups:\n* Intermediate risk - includes the presence of any of the following, assuming no high risk features apply:\n\n * Gleason 7 (3+4 or 4+3)\n * T2 (N0, M0-X)\n * PSA 10-20 ng/ml\n* High risk - patients with tumours that meet a maximum of 2 of the following criteria:\n\n * Gleason 4+4 (max ≤ 50% cores)\n * T3a (N0, M0)\n * PSA \\>20 ng/ml\n\nExclusion criteria (all arms):\n\n* Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival.\n* Prior pelvic radiotherapy.\n* Prior androgen deprivation therapy (including androgen agonists and antagonists) for PACE-A and PACE-B participants.\n* Any prior active treatment for prostate cancer (with the exception of ADT for PACE-C participants). Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.\n* Life expectancy \\<5 years.\n* Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts.\n* Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms.\n* For patients having fiducials inserted: Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician.\n* Participation in another concurrent treatment protocol for prostate cancer.\n\nSpecific exclusion criteria for PACE-C:\n\n* \\>14 weeks of androgen deprivation therapy prior to randomisation\n* Medical conditions likely to make ADT inadvisable (e.g. significant and ongoing cardiac issues).'}, 'identificationModule': {'nctId': 'NCT01584258', 'acronym': 'PACE', 'briefTitle': 'Prostate Advances in Comparative Evidence', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer', 'orgStudyIdInfo': {'id': 'CCR3766'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PACE-A: Prostatectomy vs prostate SBRT', 'description': 'Low and intermediate risk patients, for whom surgery is considered, will be randomised to prostatectomy vs prostate SBRT delivered with 36.25 Gy in 5 fractions.', 'interventionNames': ['Procedure: Prostatectomy', 'Radiation: Prostate SBRT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PACE-B: Conventionally Fractionated RT vs Prostate SBRT', 'description': 'Low and intermediate risk patients, for whom surgery is not considered or who refuse surgery, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 78 Gy in 39 fractions or 62 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.', 'interventionNames': ['Radiation: Conventionally Fractionated Prostate Radiotherapy', 'Radiation: Prostate SBRT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PACE-C: Conventionally Fractionated RT vs Prostate SBRT', 'description': 'Intermediate and high risk patients, indicated for 6 months ADT, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 60 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.', 'interventionNames': ['Radiation: Conventionally Fractionated Prostate Radiotherapy', 'Radiation: Prostate SBRT']}], 'interventions': [{'name': 'Prostatectomy', 'type': 'PROCEDURE', 'description': 'Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.', 'armGroupLabels': ['PACE-A: Prostatectomy vs prostate SBRT']}, {'name': 'Conventionally Fractionated Prostate Radiotherapy', 'type': 'RADIATION', 'description': 'Conventional fractionation delivered to a dose of:\n\n(PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions', 'armGroupLabels': ['PACE-B: Conventionally Fractionated RT vs Prostate SBRT', 'PACE-C: Conventionally Fractionated RT vs Prostate SBRT']}, {'name': 'Prostate SBRT', 'type': 'RADIATION', 'description': 'Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.', 'armGroupLabels': ['PACE-A: Prostatectomy vs prostate SBRT', 'PACE-B: Conventionally Fractionated RT vs Prostate SBRT', 'PACE-C: Conventionally Fractionated RT vs Prostate SBRT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northeast Cancer Centre', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Niagara', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Walker Family Cancer Centre', 'geoPoint': {'lat': 43.64455, 'lon': -79.40712}}, {'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lakeridge Health', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Charles-LeMoyne', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Maisonneuve Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beacon Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': 'PE29 6NT', 'city': 'Huntingdon', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Hinchingbrooke Hospital', 'geoPoint': {'lat': 52.33049, 'lon': -0.18651}}, {'zip': 'CO4 5JL', 'city': 'Colchester', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Colchester General Hospital', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'HA6 2RN', 'city': 'London', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Centre', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'University Hospital Coventry & Warwickshire NHS Trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Royal United Hospital', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Boston', 'country': 'United Kingdom', 'facility': 'Pilgrim Hospital', 'geoPoint': {'lat': 52.97633, 'lon': -0.02664}}, {'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Bury', 'country': 'United Kingdom', 'facility': 'West Suffolk Hospital', 'geoPoint': {'lat': 53.6, 'lon': -2.3}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Canterbury', 'country': 'United Kingdom', 'facility': 'Kent and Canterbury Hospital', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Cheltenham', 'country': 'United Kingdom', 'facility': 'Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'The Beatson', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'city': 'Ipswich', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Lincoln', 'country': 'United Kingdom', 'facility': 'Lincoln County Hospital', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'zip': 'NW3 2QC', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College, London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'North Middlesex University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Maidstone', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'facility': 'Clatterbridge Cancer Centre', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'city': 'Northampton', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk & Norwich Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Peterborough', 'country': 'United Kingdom', 'facility': 'Peterborough City Hospital', 'geoPoint': {'lat': 52.57364, 'lon': -0.24777}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Rhyl', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'city': 'Romford', 'country': 'United Kingdom', 'facility': 'Queens Hospital', 'geoPoint': {'lat': 51.57515, 'lon': 0.18582}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'Royal Stoke University Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'Sunderland Royal Hospital', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'city': 'Sutton in Ashfield', 'country': 'United Kingdom', 'facility': 'Kings Mill Hospital', 'geoPoint': {'lat': 53.12542, 'lon': -1.26135}}, {'city': 'Torquay', 'country': 'United Kingdom', 'facility': 'Torbay District General Hospital', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'city': 'Westcliff-on-Sea', 'country': 'United Kingdom', 'facility': 'Southend University Hospital', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}, {'city': 'Worcester', 'country': 'United Kingdom', 'facility': 'Worcestershire Royal Hospital', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}], 'overallOfficials': [{'name': 'Nicholas van As, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom'}, {'name': 'Peter Ostler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Vernon Cancer Centre, United Kingdom'}, {'name': 'Alison Tree, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Institute of Cancer Research, Sutton, Surrey, UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}