Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT00003594
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
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': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1691}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-09-24', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to progression', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'Up to 5 years'}, {'measure': 'time to treatment failure', 'timeFrame': 'Up to 5 years'}, {'measure': 'response rate', 'timeFrame': 'Up to 5 years'}, {'measure': 'quality of life', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage III colon cancer', 'stage IV colon cancer', 'stage III rectal cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '22162570', 'type': 'BACKGROUND', 'citation': 'Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.'}, {'pmid': '21880789', 'type': 'BACKGROUND', 'citation': 'An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31.'}, {'type': 'BACKGROUND', 'citation': 'Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.'}, {'pmid': '18182660', 'type': 'BACKGROUND', 'citation': 'Grothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ. Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008 Jan 10;26(2):183-9. doi: 10.1200/JCO.2007.13.8099.'}, {'type': 'BACKGROUND', 'citation': 'Grothey A, Hedrick EE, Mass RD, et al.: Response rate using conventional criteria is a poor surrogate for clinical benefit on progression-free (PFS) and overall survival (OS) in metastatic colorectal cancer (mCRC): a comparative analysis of N9741 and AVF2107. [Abstract] J Clin Oncol 24 (Suppl 18): A-3516, 2006.'}, {'pmid': '11204663', 'type': 'BACKGROUND', 'citation': 'Goldberg R. Oxaliplatin in colorectal cancer: current studies. Oncology (Williston Park). 2000 Dec;14(12 Suppl 11):42-7.'}, {'pmid': '21632455', 'type': 'RESULT', 'citation': 'Heun JM, Grothey A, Branda ME, Goldberg RM, Sargent DJ. Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741. Oncologist. 2011;16(6):859-67. doi: 10.1634/theoncologist.2011-0064. Epub 2011 May 31.'}, {'pmid': '21422438', 'type': 'RESULT', 'citation': 'Ng K, Sargent DJ, Goldberg RM, Meyerhardt JA, Green EM, Pitot HC, Hollis BW, Pollak MN, Fuchs CS. Vitamin D status in patients with stage IV colorectal cancer: findings from Intergroup trial N9741. J Clin Oncol. 2011 Apr 20;29(12):1599-606. doi: 10.1200/JCO.2010.31.7255. Epub 2011 Mar 21.'}, {'pmid': '20697547', 'type': 'RESULT', 'citation': 'Goldberg RM, Sargent DJ, McLeod H. Leveraging learning from a phase III colorectal cancer clinical trial: outcomes, methodology, meta-analysis and pharmacogenetics. Trans Am Clin Climatol Assoc. 2010;121:21-32; discussion 32-3.'}, {'pmid': '20530282', 'type': 'RESULT', 'citation': 'McLeod HL, Sargent DJ, Marsh S, Green EM, King CR, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Thibodeau SN, Grothey A, Morton RF, Goldberg RM. Pharmacogenetic predictors of adverse events and response to chemotherapy in metastatic colorectal cancer: results from North American Gastrointestinal Intergroup Trial N9741. J Clin Oncol. 2010 Jul 10;28(20):3227-33. doi: 10.1200/JCO.2009.21.7943. Epub 2010 Jun 7.'}, {'pmid': '19828593', 'type': 'RESULT', 'citation': 'Goldberg RM, Sargent DJ, Morton RF, Green E, Sanoff HK, McLeod H, Buckner J. NCCTG Study N9741: leveraging learning from an NCI Cooperative Group phase III trial. Oncologist. 2009 Oct;14(10):970-8. doi: 10.1634/theoncologist.2009-0175. Epub 2009 Oct 14.'}, {'pmid': '19636001', 'type': 'RESULT', 'citation': 'Sanoff HK, Sargent DJ, Green EM, McLeod HL, Goldberg RM. Racial differences in advanced colorectal cancer outcomes and pharmacogenetics: a subgroup analysis of a large randomized clinical trial. J Clin Oncol. 2009 Sep 1;27(25):4109-15. doi: 10.1200/JCO.2009.21.9527. Epub 2009 Jul 27.'}, {'pmid': '19073970', 'type': 'RESULT', 'citation': 'Fuchs CS, Goldberg RM, Sargent DJ, Meyerhardt JA, Wolpin BM, Green EM, Pitot HC, Pollak M. Plasma insulin-like growth factors, insulin-like binding protein-3, and outcome in metastatic colorectal cancer: results from intergroup trial N9741. Clin Cancer Res. 2008 Dec 15;14(24):8263-9. doi: 10.1158/1078-0432.CCR-08-0480. Epub 2008 Dec 10.'}, {'pmid': '19001325', 'type': 'RESULT', 'citation': 'Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.'}, {'type': 'RESULT', 'citation': 'Sargent DJ, Campbell M, Grothey A, et al.: Overall and 12 week tumor response versus actual tumor measurements as predictors of overall survival (OS) in advanced colorectal cancer (ACRC): findings from NCCTG N9741. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-446, 2008.'}, {'pmid': '17687151', 'type': 'RESULT', 'citation': 'Dy GK, Krook JE, Green EM, Sargent DJ, Delaunoit T, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pockaj BA, Sticca RP, Alberts SR, Pitot HC 4th, Goldberg RM; Intergroup N9741. Impact of complete response to chemotherapy on overall survival in advanced colorectal cancer: results from Intergroup N9741. J Clin Oncol. 2007 Aug 10;25(23):3469-74. doi: 10.1200/JCO.2007.10.7128.'}, {'type': 'RESULT', 'citation': 'Grothey A, Sargent DJ, Campbell ME, et al.: Waterfall plots provide detailed information on magnitude of response to conventional chemotherapy in colorectal cancer: lessons learned from N9741. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-337, 2007.'}, {'type': 'RESULT', 'citation': 'Goldberg RM, McLeod HL, Sargent DJ, et al.: Genetic polymorphisms, toxicity, and response rate in African Americans (AA) with metastatic colorectal cancer (MCRC) compared to Caucasians (C) when treated with IFL, FOLFOX or IROX in Intergroup N9741. [Abstract] J Clin Oncol 24 (Suppl 18): A-3503, 2006.'}, {'pmid': '16849748', 'type': 'RESULT', 'citation': 'Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts S. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial. J Clin Oncol. 2006 Jul 20;24(21):3347-53. doi: 10.1200/JCO.2006.06.1317.'}, {'type': 'RESULT', 'citation': 'McLeod HL, Parodi L, Sargent DJ, et al.: UGT1A1*28, toxicity and outcome in advanced colorectal cancer: results from trial N9741. [Abstract] J Clin Oncol 24 (Suppl 18): A-3520, 2006.'}, {'pmid': '15677624', 'type': 'RESULT', 'citation': 'Delaunoit T, Alberts SR, Sargent DJ, Green E, Goldberg RM, Krook J, Fuchs C, Ramanathan RK, Williamson SK, Morton RF, Findlay BP. Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741. Ann Oncol. 2005 Mar;16(3):425-9. doi: 10.1093/annonc/mdi092. Epub 2005 Jan 27.'}, {'type': 'RESULT', 'citation': 'Dy GK, Krook J, Green E, et al.: Impact of complete response to chemotherapy on overall survival (OS) in advanced colorectal cancer (CRC): results from Intergroup N9741. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-185, 2005.'}, {'pmid': '15470715', 'type': 'RESULT', 'citation': 'Delaunoit T, Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Findlay BP, Thomas SP, Salim M, Schaefer PL, Stella PJ, Green E, Mailliard JA. Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or oxaliplatin: results from Intergroup Trial N9741. Cancer. 2004 Nov 15;101(10):2170-6. doi: 10.1002/cncr.20594.'}, {'pmid': '14665611', 'type': 'RESULT', 'citation': 'Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):23-30. doi: 10.1200/JCO.2004.09.046. Epub 2003 Dec 9.'}, {'type': 'RESULT', 'citation': 'Goldberg RM, Morton RF, Sargent DJ, et al.: N9741: oxaliplatin (Oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Updated efficacy and quality of life (QOL) data from an intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1009, 252, 2003.'}, {'type': 'RESULT', 'citation': 'Goldberg RM, Morton RF, Sargent D, et al.: N9741: oxaliplatin (oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Initial toxicity and response data from a GI Intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-511, 2002.'}, {'type': 'RESULT', 'citation': 'Morton RF, Goldberg RM, Sargent DJ, et al.: Oxaliplatin (OXAL) or CPT-11 Combined with 5FU/Leucovorin (LV) in Advanced Colorectal Cancer (CRC): an NCCTG/CALGB Study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-495, 2001.'}, {'pmid': '31104167', 'type': 'DERIVED', 'citation': 'Yuan C, Renfro L, Ambadwar PB, Ou FS, McLeod HL, Innocenti F, Meyerhardt JA, Wolpin BM, Goldberg RM, Grothey A, Fuchs CS, Ng K. Influence of genetic variation in the vitamin D pathway on plasma 25-hydroxyvitamin D3 levels and survival among patients with metastatic colorectal cancer. Cancer Causes Control. 2019 Jul;30(7):757-765. doi: 10.1007/s10552-019-01183-1. Epub 2019 May 18.'}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan.\n* Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens.\n* Compare the toxicity of these regimens in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms.\n\nOnly arm II remains open to accrual.\n\n* Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.)\n* Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks.\n* Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy\n\n * Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:\n\n * More than 5 years has elapsed since primary surgery OR\n * Primary cancer was stage I or II\n* Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel\n* Measurable or evaluable disease\n* No CNS metastases or carcinomatous meningitis\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9.0 g/dL (transfusion allowed)\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* AST no greater than 5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No uncontrolled hypertension\n* No unstable angina\n* No symptomatic congestive heart failure\n* No myocardial infarction within the past 6 months\n* No serious uncontrolled arrhythmia\n* No New York Heart Association class III or IV cardiac disease\n\nPulmonary:\n\n* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung\n* No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active or uncontrolled infection\n* No symptomatic sensory peripheral neuropathy\n* No known allergy to platinum compounds\n* No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician\n* No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis\n* No medical or psychiatric conditions that would preclude study\n* No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day\n* Colostomy or ileostomy allowed at investigator's discretion\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease\n* No concurrent sargramostim (GM-CSF)\n\nChemotherapy:\n\n* No prior chemotherapy for advanced colorectal cancer\n* No prior standard adjuvant chemotherapy for rectal cancer\n* Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)\n* No prior radiotherapy to more than 15% of bone marrow\n* No prior standard adjuvant radiotherapy for rectal cancer\n\nSurgery:\n\n* See Disease Characteristics\n* At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered\n* Insertion of a vascular access device not considered major or minor surgery\n\nOther:\n\n* No other concurrent investigational agents"}, 'identificationModule': {'nctId': 'NCT00003594', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum', 'orgStudyIdInfo': {'id': 'NCCTG-N9741'}, 'secondaryIdInfos': [{'id': 'CDR0000066665', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'CAN-NCIC-CO13'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'irinotecan + leucovorin + fluorouracil', 'description': 'Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.', 'interventionNames': ['Drug: irinotecan', 'Drug: fluorouracil', 'Drug: leucovorin calcium']}, {'type': 'EXPERIMENTAL', 'label': 'oxaliplatin + leucovorin + fluorouracil', 'description': 'Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.', 'interventionNames': ['Drug: fluorouracil', 'Drug: leucovorin calcium', 'Drug: oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'oxaliplatin + irinotecan', 'description': 'Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.', 'interventionNames': ['Drug: irinotecan', 'Drug: oxaliplatin']}], 'interventions': [{'name': 'irinotecan', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + leucovorin + fluorouracil', 'oxaliplatin + irinotecan']}, {'name': 'fluorouracil', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + leucovorin + fluorouracil', 'oxaliplatin + leucovorin + fluorouracil']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + leucovorin + fluorouracil', 'oxaliplatin + leucovorin + fluorouracil']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['oxaliplatin + irinotecan', 'oxaliplatin + leucovorin + fluorouracil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1996', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'MBCCOP - Gulf Coast', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Greater Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Phoenix (Hayden)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85054-4502', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - 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