Phase 2
N=27
Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00831181 ↗Enrolled (actual)
27
Serious AEs
59.3%
Results posted
Mar 2018
Primary outcome: Primary: Pathologic Response and Complete Response — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5-FU (Drug); Oxaliplatin (Drug); leucovorin (Drug); mesorectal excision (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Medical Center
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Response and Complete Response |
3 | — |
| SECONDARY Treatment Toxicity |
16 | — |
| SECONDARY Complete Resectability Rates |
3 | — |
| SECONDARY Local Regional Control |
21 | — |
| SECONDARY Disease-free Survival |
16 | — |
| SECONDARY Overall Survival |
21 | — |
| SECONDARY Patterns of Disease Failure, Including Local Recurrence and Distant Metastasis Assessed by CT Scan |
2 | — |
| SECONDARY Number of Participants With Comparison of Preoperative Stage With Post-treatment Pathologic Stage |
13 | — |
Summary
RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer.
Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant
PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant combination chemotherapy with radiation works in treating patients undergoing surgery for rectal cancer.
Eligibility Criteria
Inclusion Criteria
- Histologically proven adenocarcinoma of the rectum with no distant metastases.
- T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT
- The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by protoscopic examination.
- No prior chemotherapy or pelvic irradiation.
- ECOG performance status 0-1
- Age 18 to 70 years
- ANC >= 1500/mm3 and platelets >= 100,000/mm3
- Serum creatinine grade 1
- History within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma.
- HIV positive patients
Data sourced from ClinicalTrials.gov (NCT00831181). 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.