Clinical trial · Interventional
Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer
CLOCC Trial (Chemotherapy + Local Ablation Versus Chemotherapy) Randomized Phase II Study Of Local Treatment Of Liver Metastases By Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone In Patients With Unresectable Colorectal Liver Metastases
NCT00043004CI-TRIAL-00008080terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival rate as measured by Kaplan Meier method at 30 months
Secondary outcomes (5)
- measure
- Overall survival as measured by Logrank every 3 months for 30 months then every 6 months thereafter
- measure
- Progression-free survival as measured by Logrank every 3 months for 30 months then every 6 months thereafter
- measure
- Toxicity as measured by CTC version 2.0 every 3 months for 30 months then every 6 months thereafter
- measure
- Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 at baseline, weeks 6, 12, 18, and 24, every 3 months for years 1-2 after start of treatment, then every 6 months thereafter
- measure
- Response to treatment (arm II) as measured by RECIST criteria from start of treatment until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 * No bleeding disorder or coagulopathy or need for full-dose anticoagulation 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 * Protein \< 0.5 g/24 hr urine collection if proteinuria positive by dipstick Cardiovascular * No uncontrolled congestive heart failure * No uncontrolled angina pectoris * No uncontrolled hypertension * No uncontrolled arrhythmia * No myocardial infarction within the past 12 months * No cerebrovascular accident or transient ischemic attack within the past 6 months 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, oxaliplatin, or bevacizumab * 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 * More than 28 days since major surgery or open biopsy past 28 days * More than 28 days since significant traumatic injury Other * No other concurrent investigational treatment * No other concurrent anticancer therapy
References
Publications (2)
- RESULTRuers T, van Coevorden F, Pierie J, et al.: Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): interim results of a randomised phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC). [Abstract] J Clin Oncol 26 (Suppl 15): A-9535, 2008.
- DERIVEDRuers T, Punt C, Van Coevorden F, Pierie JPEN, Borel-Rinkes I, Ledermann JA, Poston G, Bechstein W, Lentz MA, Mauer M, Van Cutsem E, Lutz MP, Nordlinger B; EORTC Gastro-Intestinal Tract Cancer Group; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO) and the National Cancer Research Institute Colorectal Clinical Study Group (NCRI CCSG). Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004). Ann Oncol. 2012 Oct;23(10):2619-2626. doi: 10.1093/annonc/mds053. Epub 2012 Mar 19. PMID 22431703