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NCT00113230 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Chemoradiation With RHUMAB VEGF (Avastin) for Rectal Cancer
A Phase 2 study of Rectal Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00113230 is a Phase 2 study of Rectal Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 3,167-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00113230, a Phase 2 study of Rectal Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Capecitabine
- RADIATION Radiation Therapy
- DRUG Avastin (Bevacizumab, RHUMAB VEGF)
Study Locations (1)
Texas
- UT M. D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-02 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113230
The ClinicalTrials.gov registry entry for NCT00113230 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,167-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.
NCT00113230 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00113230 about?
NCT00113230 is a clinical study titled "Neoadjuvant Chemoradiation With RHUMAB VEGF (Avastin) for Rectal Cancer". 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 c...
What is the current status of trial NCT00113230?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2005-02. Estimated completion is 2009-01.
What conditions does trial NCT00113230 study?
This clinical trial studies the following conditions: Rectal Cancer.
What interventions are being tested in trial NCT00113230?
The interventions under investigation include: Capecitabine (DRUG), Radiation Therapy (RADIATION), Avastin (Bevacizumab, RHUMAB VEGF) (DRUG).
Who is sponsoring clinical trial NCT00113230?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00113230 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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