At a glance
ClinicalIndex Comparison Record- ✓Histologically proven adenocarcinoma of the rectum, Stage II or III (T3N0M0, T4N0M0, or TanyN1-3M0)
- ✓Tumor distal border at or below peritoneal reflection (≤12 cm from anal verge by proctoscopy, or confirmed below peritoneal reflection at surgery)
- ✓Transmural tumor penetration through muscularis propria demonstrated by CT, endo-rectal ultrasound, or MRI
- ✓Completely resected tumor and within 21–56 days from surgery date at randomization
- ✕Prior chemotherapy or pelvic irradiation therapy (for Group I and Group II registrations)
- ✕Active inflammatory bowel disease or serious medical illness limiting ability to receive protocol therapy
- ✕Pregnant or breast-feeding
- ✕Previous or concurrent malignancy (except non-melanoma skin cancer, in situ cervical cancer, or treated non-pelvic cancer disease-free >5 years)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intergroup Randomized Phase III Study of Postoperative Irinotecan, 5-Fluorouracil and Leucovorin vs. Oxaliplatin, 5-Fluorouracil and Leucovorin vs. 5-Fluorouracil and Leucovorin for Patients With Stage II or III Rectal Cancer Receiving Either Preoperative Radiation and 5-Fluorouracil or Postoperative Radiation and 5-Fluorouracil
In Brief
A Phase 3 clinical trial evaluating Radiotherapy, Fluorouracil, and 3 other interventions for Rectal Mucinous Adenocarcinoma and 10 related conditions. Completed, enrolled 225 participants across 1 site.
Detailed Summary
This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer.
Study Details
Timeline
Interventions
Undergo external beam radiation therapy
Given IV
Given IV
Given IV
Given IV