Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01613469
Status:
TERMINATED
Last Update Posted:
2018-08-16
First Post:
2012-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Re-eval of patient population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.', 'timeFrame': 'One year from the time of chemoradiation', 'description': 'Primary endpoints are the proportion of subjects with complete clinical response to chemoradiation therapy at no sooner than 9 weeks from treatment completion, and maintenance of continuous freedom from local failure for one year.'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects with complete pathological response at surgical resection', 'timeFrame': 'One year from chemoradiation therapy', 'description': 'At surgical intervention for incomplete clinical response or recurrence, complete pathological response is no evidence of residual disease at pathological examination of the resected specimen.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fluorouracil', 'leucovorin', 'radiotherapy', 'neoadjuvant therapy'], 'conditions': ['Rectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '15532809', 'type': 'BACKGROUND', 'citation': 'Habr-Gama A, Perez RO, Kiss DR, Rawet V, Scanavini A, Santinho PM, Nadalin W. Preoperative chemoradiation therapy for low rectal cancer. Impact on downstaging and sphincter-saving operations. Hepatogastroenterology. 2004 Nov-Dec;51(60):1703-7.'}, {'pmid': '9749491', 'type': 'BACKGROUND', 'citation': 'Habr-Gama A, de Souza PM, Ribeiro U Jr, Nadalin W, Gansl R, Sousa AH Jr, Campos FG, Gama-Rodrigues J. Low rectal cancer: impact of radiation and chemotherapy on surgical treatment. Dis Colon Rectum. 1998 Sep;41(9):1087-96. doi: 10.1007/BF02239429.'}, {'pmid': '15623449', 'type': 'BACKGROUND', 'citation': 'Habr-Gama A, Perez RO, Nadalin W, Nahas SC, Ribeiro U Jr, Silva E Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Long-term results of preoperative chemoradiation for distal rectal cancer correlation between final stage and survival. J Gastrointest Surg. 2005 Jan;9(1):90-9; discussion 99-101. doi: 10.1016/j.gassur.2004.10.010.'}, {'pmid': '19934911', 'type': 'BACKGROUND', 'citation': 'Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, Sao Juliao GP, Gama-Rodrigues J. Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period. Dis Colon Rectum. 2009 Dec;52(12):1927-34. doi: 10.1007/DCR.0b013e3181ba14ed.'}, {'pmid': '19160360', 'type': 'BACKGROUND', 'citation': 'Habr-Gama A, Perez RO. Non-operative management of rectal cancer after neoadjuvant chemoradiation. Br J Surg. 2009 Feb;96(2):125-7. doi: 10.1002/bjs.6470. No abstract available.'}, {'pmid': '16550556', 'type': 'BACKGROUND', 'citation': 'Petersen S, Hellmich G, von Mildenstein K, Porse G, Ludwig K. Is surgery-only the adequate treatment approach for T2N0 rectal cancer? J Surg Oncol. 2006 Apr 1;93(5):350-4. doi: 10.1002/jso.20452.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.', 'detailedDescription': 'Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of 5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good success in achieving complete clinical response, avoiding surgical intervention. If at follow-up remaining disease is found or if there is recurrent disease, surgery can be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* over 18 years old\n* tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed\n* clinical/radiological stages T2,T3,or T4, N0-1\n* ANC \\>1500, PLT\\>100,000\n* AST and alkaline phosphatase \\< 2.5 X ULN\n* bilirubin \\< 1.5 X ULN\n* CrCl \\> 50 ml/min using Cockcroft-Gault formula\n* KPS \\>60\n* ECOG Performance Scale 0-2\n* No malignancies within previous 5 years other than non-melanoma skin cancer, in-situ cervical cancer, in-situ ductal breast cancer\n* no evidence of metastatic disease\n\nExclusion Criteria:\n\n* initial tumor fixation to pelvic bone or side wide; technically unresectable disease\n* any evidence of distant metastasis\n* perforation\n* obstruction\n* hereditary non-polyposis colorectal cancer\n* synchronous primary colon carcinomas except T1 lesions\n* known dihydropyrimidine dehydrogenase deficiency\n* prior radiation therapy to the pelvis\n* prior chemotherapy for malignancies\n* known existing uncontrolled coagulopathy\n* pregnancy or lactation\n* women of childbearing potential not using reliable and appropriate contraceptive method\n* serious, uncontrolled concurrent infection(s)\n* participation in any investigational drug study within 4 weeks preceding the start of study treatment\n* clinically significant heart disease\n* other serious uncontrolled medical conditions that might compromise study participation (in the investigator's opinion)\n* major surgery within 4 weeks prior to the study treatment\n* lack of physical integrity of the upper GI tract or malabsorption syndrome"}, 'identificationModule': {'nctId': 'NCT01613469', 'briefTitle': 'Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer', 'organization': {'class': 'INDIV', 'fullName': 'Marks, John, M.D.'}, 'officialTitle': 'Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer', 'orgStudyIdInfo': {'id': 'R12-3092L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '5FU/Leucovorin- post distal rectal srgy', 'description': 'Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer', 'interventionNames': ['Drug: 5FU/Leucovorin']}], 'interventions': [{'name': '5FU/Leucovorin', 'type': 'DRUG', 'otherNames': ['SOC intervention'], 'description': '450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles during radiation (one cycle is the administration every day for 3 consecutive days, a cycle is 21 days)followed by 450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles after completion of radiation.', 'armGroupLabels': ['5FU/Leucovorin- post distal rectal srgy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Medical Center', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}], 'overallOfficials': [{'name': 'John Marks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Main Line Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marks, John, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}