At a glance
ClinicalIndex Comparison Record- ✓Adenocarcinoma of the rectum at or below 12 cm from anal verge without distant metastases
- ✓Age ≥18 years
- ✓Potentially resectable disease by surgeon evaluation
- ✓Clinical stages T3 or T4 by endorectal ultrasound or physical exam
- ✕Any evidence of distant metastasis
- ✕Synchronous primary colon carcinomas except T1 lesions
- ✕Extension of malignant disease to the anal canal
- ✕Prior radiation therapy to the pelvis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Trial Of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating Radiation Therapy, Capecitabine 1650 mg/m^2/day, and 6 other interventions for Colorectal Cancer. Completed, enrolled 146 participants across 5 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy work in 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. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
Study Details
Timeline
Interventions
Pelvic radiation therapy given once daily 5 days a week for 6 weeks, 45 Gy in 25 fractions + boost of 5.4 Gy in 3 fractions for a total dose of 50.4 Gy.
825 mg/m\^2 q12 hours (1650 mg/m\^2/day) orally 5 days per week during radiotherapy.
600 mg/m\^2 q12 hours(1200 mg/m\^2/day) orally 5 days per week during radiotherapy.
50mg/m\^2 IV over 1 hour on days 1, 8, 22, and 29
50mg/m\^2 IV over 2 hours on days 1, 8, 15, 22, and 29
All patients will undergo surgery four to eight weeks following the completion of radiation therapy. The choice of procedure abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis is at the discretion of the surgeon.
400 mg/m\^2 IV over 2 hours Day 1 (postoperatively) ,every 14 days, for nine 14-day cycles.
5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 (postoperatively), every 14 days, for nine 14-day cycles. 5-fluorouracil infusion 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning day 1, every 14 days, for nine 14-day cycles.
85 mg/m\^2 IV over 2 hours Day 1 (postoperatively), every 14 days, for nine 14-day cycles.