Clinical trial · Interventional
Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation
NCT03135652CI-TRIAL-00072705withdrawnPhase 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): Inadequate patient enrollment
Summary
Brief summary (as posted)
This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy combined with surgical resection or radiofrequency ablation of liver lesions.
Conditions
Conditions (3)
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 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant SBRT | Radiation | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- chemoradiotherapy
- description
- radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
- interventionNames
- Radiation: adjuvant SBRT
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Disease free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy proven unresectable metastatic colorectal cancer (CRC) 2. Primary resection of colorectal cancer (CRC) 3. Age≥18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Absence of evidence of extra-hepatic diseases 6. 1 to 3 liver metastases with an individual maximum diameter of up to 5 cm 7. Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed 8. Aspartate aminotransferase, alanine aminotransferase \& alkaline phosphates must be ≤ 2.5 times of the upper limit of normal. Total bilirubin must be within the limit of normal. 9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. 10. Patients must provide verbal and written informed consent to participate in the study. 11. Absence of any severe pulmonary or cardiac diseases Exclusion Criteria: 1. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible 2. Patients who are pregnant 3. Patients with severe organ dysfunction 4. History of liver radiotherapy 5. Unwillingness to participate or inability to comply with the protocol for the duration of the study 6. Participation in any investigational drug study within 3 months preceding the start of study treatment 7. Patients not suitable to take part in clinical trials judged by researches
References
Publications (2)
- RESULTNordlinger B, Guiguet M, Vaillant JC, Balladur P, Boudjema K, Bachellier P, Jaeck D. Surgical resection of colorectal carcinoma metastases to the liver. A prognostic scoring system to improve case selection, based on 1568 patients. Association Francaise de Chirurgie. Cancer. 1996 Apr 1;77(7):1254-62. PMID 8608500
- RESULTGomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24. PMID 27789196