Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT02353858
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D000084462', 'term': 'Hyperthermia'}, {'id': 'D000095384', 'term': 'Pathologic Complete Response'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response rate', 'timeFrame': 'After surgical resection (4-6 weeks after last radiotherapy fraction)'}], 'secondaryOutcomes': [{'measure': 'Locoregional progression free survival', 'timeFrame': '3 years'}, {'measure': 'Disease free survival', 'timeFrame': '3 years'}, {'measure': 'Distant metastases free survival', 'timeFrame': '3 years'}, {'measure': 'Overall survival', 'timeFrame': '3 years'}, {'measure': 'Number of hyperthermia treatments', 'timeFrame': 'At completion of hyperthermic radiochemotherapy'}, {'measure': 'Acute and chronic treatment related toxicity, according to CTC criteria', 'timeFrame': '3 years'}, {'measure': 'post operative morbidity', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rectal Cancer', 'Hyperthermia', 'Radiochemotherapy', 'Chemoradiotherapy', 'Deep regional hyperthermia', 'pathologic complete response', 'Regression Grade', 'Locally advanced rectal cancer', 'complete response'], 'conditions': ['Rectal Cancer', 'Locally Advanced Rectal Cancer', 'Hyperthermia', 'Hyperthermic Radiochemotherapy', 'Hyperthermic Chemoradiotherapy', 'Deep Regional Hyperthermia']}, 'referencesModule': {'references': [{'pmid': '33741467', 'type': 'DERIVED', 'citation': 'Gani C, Lamprecht U, Ziegler A, Moll M, Gellermann J, Heinrich V, Wenz S, Fend F, Konigsrainer A, Bitzer M, Zips D. Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial. Radiother Oncol. 2021 Jun;159:155-160. doi: 10.1016/j.radonc.2021.03.011. Epub 2021 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge)\n* International Union Against Cancer stages II or III\n* ECOG PS 0/2\n* Informed consent\n\nExclusion Criteria:\n\n* Congestive heart failure (NYHA III/IV)\n* History of myocardial infarction within the last 6 months.\n* AV Block III\n* Total hip replacement or major metal pelvic implants\n* Cardiac pacemaker\n* Contraindications for radiochemotherapy\n* Contraindications for surgical tumor resection\n* Previous pelvic radiotherapy or chemotherapy\n* Active chronic inflammatory bowel disease\n* Collagenosis\n* Congenital diseases with increased radiosensitivity\n* Pregnancy or breastfeeding\n* Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal'}, 'identificationModule': {'nctId': 'NCT02353858', 'acronym': 'HT01', 'briefTitle': 'Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial', 'orgStudyIdInfo': {'id': 'HT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RtChx + Hyperthermia', 'description': 'Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week', 'interventionNames': ['Other: Deep regional hyperthermia', 'Radiation: Radiotherapy', 'Drug: Chemotherapy (5-Fluorouracil)']}], 'interventions': [{'name': 'Deep regional hyperthermia', 'type': 'OTHER', 'description': 'Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.', 'armGroupLabels': ['RtChx + Hyperthermia']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.', 'armGroupLabels': ['RtChx + Hyperthermia']}, {'name': 'Chemotherapy (5-Fluorouracil)', 'type': 'DRUG', 'description': '5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.', 'armGroupLabels': ['RtChx + Hyperthermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Hospital Tübingen, Department of Radiation Oncology', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}