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NCT00335816 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
A Phase 2 study of Colorectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 248
- Enrollment target
- 15
- Study locations
NCT00335816: Active Phase 2 study of Colorectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00335816 is a Phase 2 study of Colorectal Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 248 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (84% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00335816, a Phase 2 study of Colorectal Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 248 participants
- Enrollment target
- 15
- Study locations
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy. Leucovorin calcium may protect normal cells from the side effects of chemotherapy, and it may help fluorouracil work better by making tumor cells more sensitive to the drug. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
Conditions Studied
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- PROCEDURE conventional surgery
- RADIATION radiation therapy
Study Locations (15)
California
- Cancer Care Center at John Muir Health - Concord Campus - Concord
- City of Hope Medical Center - Duarte
- St. Joseph Hospital Regional Cancer Center - Orange - Orange
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center - Orange
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
District of Columbia
- Washington Cancer Institute at Washington Hospital Center - Washington D.C.
Florida
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida - Tampa
Illinois
- University of Chicago Cancer Research Center - Chicago
Minnesota
- Masonic Cancer Center at University of Minnesota - Minneapolis
Missouri
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis - St Louis
Nebraska
- Colon and Rectal Surgery, Incorporated - Omaha
Ohio
- Cleveland Clinic Taussig Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2008-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT00335816 still lists
NCT00335816 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which oxaliplatin is the first listed.
NCT00335816 lists 15 locations in 11 states (California, District of Columbia, Florida).
Frequently Asked Questions
What is clinical trial NCT00335816 about?
NCT00335816 is a clinical study titled "Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Fluorouracil may also make...
What is the current status of trial NCT00335816?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2008-08. Estimated completion is 2026-12.
What conditions does trial NCT00335816 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT00335816?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00335816?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00335816 being conducted?
This trial has 15 study locations across California, District of Columbia, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00335816's enrollment target sits among peer trials
248 130th of 381 higher than 252 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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