Phase 2
N=321
Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00807911 ↗Enrolled (actual)
321
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Disease Recurrence — 53; 39 Participants — p=0.047
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adjuvant FL (Drug); Adjuvant FOLFOX (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asan Medical Center
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Disease Recurrence |
53; 39 | 0.047 sig |
| PRIMARY Number of Participants With Disease Recurrence With Pathological Stage III |
38; 29 | 0.040 sig |
| PRIMARY Number of Participants With Disease Recurrence With Pathological Stage II |
15; 10 | 0.47 |
| SECONDARY Death Rate |
21; 10 | 0.036 sig |
| SECONDARY Pattern of Recurrence |
53; 39; 12; 5; 44; 35 | — |
Summary
The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the rectum
- Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.
- AJCC/UICC pathologic stages of ypT3-4 or ypN+
- Curative surgery not less than 3 and not more than 8 weeks prior to randomization
- No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer
- ECOG PS 0-1
- Adequate organ function
- Informed Consent
Exclusion Criteria
- Macroscopic or microscopic evidence of remaining tumor
- Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- More than 8 weeks after curative surgery
Data sourced from ClinicalTrials.gov (NCT00807911). 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.