Clinical trial · Interventional
Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases
Randomized Phase II Trial of Preoperative Chemoradiation With or Without Induction Chemotherapy In Patients With Locally Advanced Or Borderlinely Resectable Rectal Cancer With Resectable Synchronous Liver Metastases
NCT01643070CI-TRIAL-00086441completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus capecitabine, with or without prior induction chemotherapy in patients with locally advanced or marginally resectable rectal cancer with resectable synchronous liver metastases.
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 |
|---|---|---|---|
| Liver Metastases | Rectal Neoplasm | PROBABILISTIC | 0.70 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Oxaliplatin | Drug | CAPOX Regimen | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- XELOX RT
- description
- Concurrent XELOX-RT (Capecitabine, Oxaliplatin, radiotherapy)
- interventionNames
- Drug: Capecitabine, Oxaliplatin
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Induction XELOX
- description
- Induction XELOX(Capecitabine, Oxaliplatin) followed by XELOX-RT (Capecitabine, Oxaliplatin, radiotherapy)
- interventionNames
- Drug: Capecitabine, Oxaliplatin
- Radiation: Radiotherapy
Primary outcomes (3)
- measure
- Quality of Surgery for Primary Tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the rectum Tumor located within 12 cm from anal verge Clinical stage of T3-4 or N+ by rectal MRI ± endorectal ultrasound Age over 18 years No prior systemic treatment or radiation Adequate major organ functions Borderline resectability of primary rectal cancer Complete resectability of liver metastases (measurable by RECIST 1.1) Exclusion Criteria: * Unresectable liver metastases (6 or more metastatic lesions, major vessel invasion) * Extrahepatic metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.