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Phase III Randomized Study of Immediate vs Delayed 5-FU/L-CF for Colorectal Cancer After Potentially Curative Resection of Liver or Lung Metastases
Alternate Title Immediate Compared With Delayed Combination Chemotherapy in Treating Colorectal Cancer Patients With Resected Liver or Lung Metastases
Objectives I. Compare overall and disease-free survival and quality of life in patients with metastatic colorectal cancer who are clinically free of disease by surgical resection of liver or lung metastases and randomized to immediate adjuvant chemotherapy with fluorouracil/l-leucovorin (5-FU/L-CF) vs. 5-FU/L-CF delayed until development of unresectable metastatic disease. Entry Criteria Disease Characteristics: Primary adenocarcinoma of the colon, rectum, or rectosigmoid space with either liver or lung metastases Distal extent of tumor is at least 3 cm from anal verge More than 1 synchronous or metachronous primary colorectal tumor allowed No more than 4 metastatic lesions involving either liver or lung (but not both) allowed Patient rendered clinically free of disease by one of the following: Resection of primary and 1 or more synchronous metastatic lesions during same operation Resection of primary and 1 or more synchronous metastatic lesions during a separate (either prior or subsequent) operative procedure Resection of 1 or more metachronous metastatic lesions subsequent to complete excision of the primary Histologically confirmed negative resection margins required for both primary and metastatic tumors Involvement of an adjacent organ by direct extension of the primary tumor or liver or lung metastasis allowed if removed en bloc with the primary tumor or liver or lung metastasis Involved regional lymph nodes removed en bloc with the primary tumor allowed No distant lymph node metastases, including: Porta hepatis Mediastinal nodes No known gross residual disease No more than 49 days between most recent resection of metastases and randomization Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except adjuvant treatment for primary tumor At least 6 months between completion of adjuvant chemotherapy and diagnosis of metastatic disease Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy except: Radiotherapy as a single-modality adjuvant treatment for the primary tumor, with diagnosis and resection of eligible metastatic disease at any time following radiotherapy Neoadjuvant radiotherapy to the primary tumor, with subsequent complete resection of primary and either liver or lung metastases Cases for which 2-stage treatment is preferable for patient safety when a primary rectal tumor and eligible metastasis are diagnosed (i.e., resection of primary, postoperative radiotherapy, and subsequent resection of metastases) No concurrent radiotherapy Surgery: Prior resection of liver or lung metastases required Patient Characteristics: Age: Any age Performance status: ECOG 0-2 Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 x ULN SGOT and SGPT no greater than 2.5 x ULN Alkaline phosphatase no greater than 2.5 x ULN Renal: Not specified Other: No medical condition that would substantially increase risk from chemotherapy No prior or concurrent second malignancy except: Adequately treated nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix No pregnant or nursing women Effective contraception required of fertile patients Expected Enrollment 478 patients will be entered over 4 years. Outline Randomized, unblinded study. Arm I: Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with L-leucovorin, L-CF. Arm II: Observation followed by Single-Agent Chemotherapy with Drug Modulation. Observation until development of unresectable recurrence; followed by 5-FU; with L-CF.Published Results Langer B, Bleiberg H, Labianca R, et al.: Fluorouracil (FU) plus l-leucovorin (l-LV) versus observation after potentially curative resection of liver or lung metastases from colorectal cancer (CRC): results of the ENG (EORTC/NCIC CTG/GIVIO) randomized trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-592, 2002. Related PublicationsMitry E, Fields AL, Bleiberg H, et al.: Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer: a pooled analysis of two randomized trials. J Clin Oncol 26 (30): 4906-11, 2008.[PUBMED Abstract] Trial Lead Organizations NCIC-Clinical Trials Group
European Organization for Research and Treatment of Cancer
European Institute of Oncology
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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