Phase 2
N=38
Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases
Rectal Cancer · Liver Metastases
Bottom Line
View on ClinicalTrials.gov: NCT01643070 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Quality of Surgery for Primary Tumor — 2; 1; 15; 19 Participants — p=0.719
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Capecitabine, Oxaliplatin (Drug); Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Asan Medical Center
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Surgery for Primary Tumor |
2; 1; 15; 19; 1; 0 | 0.719 |
| PRIMARY Quality of Surgery for Liver Metastases |
2; 1; 11; 12; 3; 2 | — |
| PRIMARY R0 Resection Rate of Both the Primary Tumor and Livermetastases |
77.8; 70.0 | — |
| SECONDARY Pathologic Complete Response Rate of Primary Tumor |
11.1; 5.0 | — |
| SECONDARY Tumor Regression Grade (Primary Tumor) |
2; 1; 2; 1; 2; 4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01643070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.