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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer  Chemotherapy With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer
Chemotherapy With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer
For Condition: Stage 4 rectal cancer,liver metastases,stage 4 colon cancer
Status: Recruiting
Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group , Arbeitsgruppe Lebermetastasen und tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie,National Cancer Research Institute (NCRI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy with or without radiofrequency ablation in treating unresectable liver metastases in patients who have colorectal cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with unresectable liver metastases secondary to colorectal adenocarcinoma treated with chemotherapy with or without radiofrequency interstitial ablation. - Compare the progression-free survival of patients treated with these regimens. - Compare quality of life of patients treated with these regimens. - Determine the health economics associated with this study. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to treatment center, prior adjuvant chemotherapy for primary cancer (yes vs no), prior chemotherapy for liver metastases (yes vs no), and route of randomization (before surgery vs during surgery). Patients are randomized to 1 of 2 treatment arms. - Arm I: Within 3-4 weeks of randomization, patients undergo radiofrequency interstitial ablation (RFA) with or without additional resection of resectable lesions. Within 8 weeks after RFA, patients receive chemotherapy. - Arm II: Within 3-4 weeks of randomization, patients receive chemotherapy In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients in both arms receive one of the following chemotherapy regimens to be determined by participating center: - Regimen A: Patients receive oxaliplatin IV over 2 hours on day 1 of weeks 1, 3, and 5 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours on day 1 of weeks 1-6. Treatment repeats every 7 weeks for 4 courses. - Regimen B: Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Treatment repeats every 15 days for 12 courses. - Regimen C: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 15 days for 12 courses. Quality of life is assessed at baseline, within 1 week after completion of RFA (arm I only), within 1 week before start of chemotherapy (arm I only), at weeks 6, 12, 18, and 24 during chemotherapy, every 3 months for 2 years after treatment, and then every 6 months thereafter. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 390 patients (195 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Unresectable liver metastases secondary to colorectal adenocarcinoma, including: - Metastases that cannot be radically resected due to size, location, or number of deposits - Metastases invading right and left branches of hepatic artery or portal vein - Metastases extended to the 3 main hepatic veins - No detectable extra-hepatic disease - Fewer than 10 metastatic deposits on liver - Total metastatic involvement of liver no more than 50% - Adequate treatment of all metastatic lesions deemed possible either by radiofrequency interstitial ablation (RFA) alone or by a combination of resection of resectable lesions and RFA of the remaining unresectable lesions - Maximum diameter of 4 cm for lesions to be treated with RFA - No maximum diameter of lesions to be resected as long as negative resection margins are obtainable - If synchronous liver metastases, must have undergone prior resection of primary tumor PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Bilirubin less than 3 times upper limit of normal (ULN) - Alkaline phosphatase less than 3 times ULN Renal - Creatinine less than 2 times ULN Cardiovascular - No uncontrolled congestive heart failure - No uncontrolled angina pectoris - No hypertension - No arrhythmia Other - Not pregnant or nursing - Fertile patients must use effective contraception - No greater than grade 1 peripheral neuropathy - No significant neurologic or psychiatric disorder - No active infection - No contraindication to the use of fluorouracil, leucovorin calcium, or oxaliplatin - No other malignancy within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy except for metastatic disease confined to the liver - Prior fluorouracil, leucovorin calcium, and oxaliplatin allowed if administered for at least 3 courses (2 weeks each) but no longer than 3 months with at least stabilization of disease achieved - Prior adjuvant chemotherapy for primary cancer allowed except for patients who received oxaliplatin and have been diagnosed with metastatic disease within 12 months after completion of adjuvant treatment Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No other concurrent investigational treatment - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
W.Bechstein, Study Chair, Arbeitsgruppe Lebermetastasen und tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-541-3111
Hopital Universitaire Hautepierre *Recruiting*
Strasbourg, , 67098
France
Recruiting Contact Person 33-388-12-8000
Allgemeines Krankenhaus der Stadt Wien *Recruiting*
Vienna, , A-1090
Austria
Recruiting Contact Person 43-40-400-2726
Cancer Research UK and University College London Cancer Trials Unit *Recruiting*
London, England, NW1 2ND
United Kingdom
Recruiting Jonathan Ledermann 44-20-7679-8040
Uppsala University Hospital *Recruiting*
Uppsala, , SE 75185
Sweden
Recruiting Contact Person 46-18-611- 0000
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Contact Person 31-387-6543
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Contact Person 33-383-59-8400
Clinique Universitaire De Mont-Godinne *Recruiting*
Mont-Godinne Yvoir, , 5530
Belgium
Recruiting Contact Person 32-42-2111
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp, , 2020
Belgium
Recruiting Contact Person 32-280-3111
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Contact Person 32-240-2011
Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie *Recruiting*
Frankfurt, , 60590
Germany
Recruiting Contact Person 49-630-15-253
Sahlgrenska University Hospital *Recruiting*
Gothenburg (Goteborg), , S-413 45
Sweden
Recruiting Contact Person 46-31-343-1000
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-821-3000
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-361-1111
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-566-9111
Additional Information:
Study ID Numbers: CDR0000069495; NCRI-EORTC-40004,EORTC-40004,ALM-CAO-EORTC-40004
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043004
Other Stage 4 Colon Cancer Studies:
1. R115777 in Treating Patients With Advanced Colorectal Cancer
2. SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
3. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
4. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
5. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Colorectal Cancer or Pancreatic Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Clinical Trials
Other Ghent Clinical Trials
Chemotherapy With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer
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