Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT00075556
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2004-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2004-01-09', 'studyFirstSubmitQcDate': '2004-01-11', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective tumor response rate'}], 'secondaryOutcomes': [{'measure': 'Tolerability'}, {'measure': 'Rate of preservation of functional integrity of the anal sphincter'}, {'measure': 'Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation'}]}, 'conditionsModule': {'keywords': ['stage III colon cancer', 'stage IV colon cancer', 'stage III rectal cancer', 'stage IV rectal cancer', 'adenocarcinoma of the rectum', 'adenocarcinoma of the colon'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '18418009', 'type': 'RESULT', 'citation': 'Dupuis O, Vie B, Lledo G, Hennequin C, Noirclerc M, Bennamoun M, Jacob JH. Preoperative treatment combining capecitabine with radiation therapy in rectal cancer: a GERCOR Phase II Study. Oncology. 2007;73(3-4):169-76. doi: 10.1159/000127383. Epub 2008 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed.\n\nPURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and capecitabine work in treating patients who are undergoing surgery for stage III or stage IV colorectal adenocarcinoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the objective tumor response rate in patients with stage III or IV colorectal adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine.\n\nSecondary\n\n* Determine the tolerance profile of this regimen in these patients.\n* Determine the rate of preservation of functional integrity of the anal sphincter in patients treated with this regimen.\n* Compare the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral capecitabine twice daily and undergo concurrent radiotherapy 5 days a week on weeks 1-5. Patients undergo surgery on week 6.\n\nPatients are followed every 4 months for 2 years and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed colorectal adenocarcinoma\n\n * Clinical stage T3, T4, N+\n* Measurable disease\n* Awaiting surgery and likely to benefit from neoadjuvant radiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 80\n\nPerformance status\n\n* ECOG 0-2 OR\n* Karnofsky 60-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count at least 2,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* AST and ALT no greater than 2.5 times ULN\n* No hepatic condition that would interfere with study medication\n\nRenal\n\n* Creatinine clearance at least 80 mL/min\n* No renal condition that would interfere with study medication\n\nCardiovascular\n\n* No serious cardiac failure with the past year\n* No myocardial infarction within the past year\n* No cardiac insufficiency\n* No angina\n* No uncontrolled arrhythmia\n* No uncontrolled hypertension\n\nGastrointestinal\n\n* No superior intestinal tract malfunction\n* No malabsorption syndrome\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No concurrent serious infection\n* No other serious illness\n* No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix\n* No metabolic condition that would interfere with study medication\n* No dementia or altered mental status\n* No psychiatric illness that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for colorectal cancer\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy for colorectal cancer\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 30 days since prior participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT00075556', 'briefTitle': 'Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer', 'orgStudyIdInfo': {'id': 'CDR0000346895'}, 'secondaryIdInfos': [{'id': 'FRE-GERCOR-R01-01'}, {'id': 'EU-20329'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'capecitabine', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Regional Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Hopital Drevon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '17000', 'city': 'La Rochelle', 'country': 'France', 'facility': 'Hopital Saint - Louis', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Jean Bernard', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Clinique Saint Jean', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '57038', 'city': 'Metz', 'country': 'France', 'facility': 'Hopital Notre-Dame de Bon Secours', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': 'Intercommunal Hospital', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '68051', 'city': 'Mulhouse', 'country': 'France', 'facility': 'Centre Hospitalier de Mulhouse', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '60309', 'city': 'Senlis', 'country': 'France', 'facility': 'C.H. Senlis', 'geoPoint': {'lat': 49.20724, 'lon': 2.58661}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Centre Medico-Chirurgical Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Olivier Dupuis, MD', 'affiliation': 'Centre Jean Bernard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GERCOR - Multidisciplinary Oncology Cooperative Group', 'class': 'OTHER'}}}}