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NCT00686166 · ClinicalTrials.gov registry record · Phase 2
S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT00686166: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT00686166 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00686166, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy 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 the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III rectal cancer.
Primary Outcome
Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cance
Interventions
- DRUG oxaliplatin
- BIOLOGICAL cetuximab
- DRUG capecitabine
- RADIATION radiation therapy
- PROCEDURE therapeutic surgical procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2009-02 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
What the finished NCT00686166 record still lists
NCT00686166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT00686166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00686166 about?
NCT00686166 is a clinical study titled "S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer". RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the abi...
What is the current status of trial NCT00686166?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2009-02. Estimated completion is 2018-03.
What interventions are being tested in trial NCT00686166?
The interventions under investigation include: oxaliplatin (DRUG), cetuximab (BIOLOGICAL), capecitabine (DRUG), radiation therapy (RADIATION), therapeutic surgical procedure (PROCEDURE).
Who is sponsoring clinical trial NCT00686166?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00686166's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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