At a glance
ClinicalIndex Comparison Record- ✓ECOG performance status 0 or 1
- ✓Age ≥18 years
- ✓Histologically confirmed rectal adenocarcinoma, clinical stage T3, T4, or recurrent
- ✓No distant metastatic disease on CT abdominopelvic imaging
- ✕Any prior chemotherapy
- ✕Any prior radiation therapy
- ✕Clinically significant cardiac disease including uncontrolled hypertension (>160/110 mmHg), myocardial infarction history, unstable angina, NYHA Grade II+ congestive heart failure, or Grade II+ peripheral vascular disease
- ✕Aneurysm, stroke, TIA, or arteriovenous malformation within the past year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial Of Neoadjuvant Concurrent Capecitabine, RHUMAB VEGF (Avastin) And Radiotherapy In Patients Presenting With Locally Advanced Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating Avastin (Bevacizumab, RHUMAB VEGF), Capecitabine, and 1 other intervention for Rectal Cancer. Completed, enrolled 25 participants across 1 site.
Detailed Summary
Preoperative chemoradiation leads to increased pelvic control and overall survival, but both distant and local disease control remain problematic in locally advanced rectal cancer patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response as well as distant disease control. Patients who have complete response to therapy have increased sphincter preservation, and can possibly have more limited surgery (full thickness local excision). When combined with standard chemotherapy, bevacizumab \[RHUMAB VEGF, Avastin\] has been shown to improve response and median survival in patients with metastatic colorectal cancer in a recent randomized trial, has led to increased activity in preclinical studies with radiotherapy, and has been found to be very well tolerated with chemoradiation in a phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard chemoradiation will safely lead to increased tumor response in patients with locally advanced rectal cancer.
Study Details
Timeline
Interventions
Starting Dose 5 mg/kg intravenously on day one of radiotherapy, given every 2 weeks +/- 2 days for a total of 3 doses.
900 mg/m\^2 by mouth twice a day during days of radiation for all five weeks of therapy.
45 Gy in 25 fractions to the pelvis followed by 5.4 Gy as a boost dose to the primary tumor with margin, for a total dose of 50.4 Gy over 28 treatment days.