Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT00002633
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom', 'United States']}, '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': 'C053541', 'term': 'bicalutamide'}, {'id': 'D002064', 'term': 'Buserelin'}, {'id': 'D005485', 'term': 'Flutamide'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C021277', 'term': 'nilutamide'}, {'id': 'D009919', 'term': 'Orchiectomy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002369', 'term': 'Castration'}, {'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2012-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Disease specific survival', 'timeFrame': '10 years'}, {'measure': 'Time to disease progression', 'timeFrame': '10 years'}, {'measure': 'Symptomatic local control measured by surgical intervention rate', 'timeFrame': '10 years'}, {'measure': 'Quality of life assessed by EORTC-QLQ-C30 + 3 and a trial-specific checklist (PR17) or the FACT-P questionnaire', 'timeFrame': '10 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage II prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '22056152', 'type': 'RESULT', 'citation': 'Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W; NCIC CTG PR.3/MRC UK PR07 investigators. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011 Dec 17;378(9809):2104-11. doi: 10.1016/S0140-6736(11)61095-7. Epub 2011 Nov 2.'}, {'pmid': '26014295', 'type': 'DERIVED', 'citation': 'Brundage M, Sydes MR, Parulekar WR, Warde P, Cowan R, Bezjak A, Kirkbride P, Parliament M, Moynihan C, Bahary JP, Parmar MK, Sanders K, Chen BE, Mason MD. Impact of Radiotherapy When Added to Androgen-Deprivation Therapy for Locally Advanced Prostate Cancer: Long-Term Quality-of-Life Outcomes From the NCIC CTG PR3/MRC PR07 Randomized Trial. J Clin Oncol. 2015 Jul 1;33(19):2151-7. doi: 10.1200/JCO.2014.57.8724. Epub 2015 May 26.'}, {'pmid': '25691677', 'type': 'DERIVED', 'citation': 'Mason MD, Parulekar WR, Sydes MR, Brundage M, Kirkbride P, Gospodarowicz M, Cowan R, Kostashuk EC, Anderson J, Swanson G, Parmar MK, Hayter C, Jovic G, Hiltz A, Hetherington J, Sathya J, Barber JB, McKenzie M, El-Sharkawi S, Souhami L, Hardman PD, Chen BE, Warde P. Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer. J Clin Oncol. 2015 Jul 1;33(19):2143-50. doi: 10.1200/JCO.2014.57.7510. Epub 2015 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.\n\nPURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.', 'detailedDescription': "OBJECTIVES:\n\n* Compare the overall survival, disease specific survival, and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation.\n* Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens.\n* Compare the quality of life of patients treated with these regimens.\n* Compare the sensitivity of the EORTC-QLQ-C30+3 and a trial-specific checklist (PR17) with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens.\n\nOUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical \\[no CT scan\\] vs radiological \\[CT scan negative\\] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone \\[LHRH\\] with antiandrogen). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive antiandrogen therapy comprising oral flutamide every 8 hours, oral nilutamide every 8 hours for 1 month and then once daily, or oral bicalutamide once daily. Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously (SC) every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), leuprolide intramuscularly every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), or buserelin SC every 8 weeks or every 12 weeks. Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery (at the physician's discretion).\n* Arm II: Patients undergo total androgen ablation as in arm I. Patients with node-negative dissection undergo radiotherapy 5 days a week for 6.5-7 weeks. All other patients undergo radiotherapy 5 days a week for 5 weeks, followed by boost radiotherapy 5 days a week for 2-2.4 weeks.\n\nHormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, on the last day of radiotherapy, at 6 months, and then every 6 months thereafter.\n\nPatients are followed at 1, 2, and 6 months and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study within 7.5 years."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following:\n\n * T3-4, N0 or NX, M0\n * T2, PSA greater than 40 µg/L\n * T2, PSA greater than 20 µg/L AND Gleason score at least 8\n* Diagnosis made within the past 6 months\n* Gleason score and PSA known\n* Pelvic lymph nodes must be clinically negative\n\n * Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis\n * Negative needle aspirate required for any lymph node more than 1.5 cm\n * If a lymph node dissection was performed, it must be histologically negative\n* No small cell or transitional cell carcinoma by biopsy\n* No bony metastases by bone scan\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Under 80\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 5 years excluding malignancy\n\nHematopoietic:\n\n* Hemoglobin at least 10.0 g/dL\n* WBC at least 2,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 2 times upper limit of normal (ULN)\n* SGOT and SGPT less than 2 times ULN\n* Alkaline phosphatase less than 2 times ULN\n* No history of chronic liver disease\n\nRenal:\n\n* Creatinine less than 2 times ULN\n\nOther:\n\n* No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability)\n* No other malignancy within the past 5 years except nonmelanoma skin cancer\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met:\n\n * Negative bone scan before beginning any hormonal therapy\n * Extracapsular extension remains palpable on rectal re-exam\n * Baseline PSA known before beginning any hormonal therapy\n* At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy\n\nRadiotherapy:\n\n* No prior pelvic irradiation\n\nSurgery:\n\n* No prior radical prostatectomy\n* Prior transurethral resection of the prostate allowed\n\nOther:\n\n* No prior cytotoxic anticancer therapy\n* No other prior treatment for prostate cancer\n* No other concurrent anticancer therapy unless documented disease progression'}, 'identificationModule': {'nctId': 'NCT00002633', 'briefTitle': 'Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate', 'orgStudyIdInfo': {'id': 'PR3'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-PR3', 'type': 'REGISTRY', 'domain': 'NCI US PDQ'}, {'id': 'ECOG-JPR03', 'type': 'OTHER', 'domain': 'ECOG'}, {'id': 'MRC-PR07', 'type': 'OTHER', 'domain': 'MRC'}, {'id': 'SWOG-JPR3', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'EU-99013', 'type': 'OTHER', 'domain': 'EU'}, {'id': 'NCI-T94-0110O', 'type': 'OTHER_GRANT', 'domain': 'NCI'}, {'id': 'ISRCTN24991896', 'type': 'REGISTRY', 'domain': 'ISRCTN'}, {'id': 'CDR0000064065', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total Androgen Blockade', 'interventionNames': ['Drug: bicalutamide', 'Drug: buserelin', 'Drug: flutamide', 'Drug: goserelin', 'Drug: leuprolide acetate', 'Drug: nilutamide', 'Procedure: orchiectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation', 'interventionNames': ['Drug: bicalutamide', 'Drug: buserelin', 'Drug: flutamide', 'Drug: goserelin', 'Drug: leuprolide acetate', 'Drug: nilutamide', 'Procedure: orchiectomy', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'bicalutamide', 'type': 'DRUG', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'name': 'buserelin', 'type': 'DRUG', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'name': 'flutamide', 'type': 'DRUG', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'name': 'goserelin', 'type': 'DRUG', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'name': 'leuprolide acetate', 'type': 'DRUG', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'name': 'nilutamide', 'type': 'DRUG', 'description': "Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk", 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'name': 'orchiectomy', 'type': 'PROCEDURE', 'description': 'Optional orchiectomy', 'armGroupLabels': ['Total Androgen Blockade', 'Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Radical Radiation Therapy - (65-69 Gy; 35-37 treatments)', 'armGroupLabels': ['Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Fraser Valley Cancer Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'P3E 5J1', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Regional Cancer Program of the Hopital Regional', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre at Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 5P9', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Centre of Southeastern Ontario at Kingston', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Program', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Health Research Institute - General Division', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'P7B 6V4', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Thunder Bay Regional Health Science Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Univ. Health Network-Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Regional Cancer Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Hopital Notre-Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University - Dept. Oncology', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Padraig R. Warde, MB, MRCPI, FRCPC', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Margaret Hospital, Canada'}, {'name': 'Richard R. Whittington, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}, {'name': 'Srinivasan Vijayakumar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Michael Reese Hospital and Medical Center'}, {'name': 'Patricia Lillis-Hearne, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Brooke Army Medical Center'}, {'name': 'Malcolm D. Mason, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Velindre NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}