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NCT00068692 · ClinicalTrials.gov registry record · Phase 3
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer
A Phase 3 study of Recurrent Rectal Carcinoma and Stage IIIA Rectal Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
- 1
- Study location
NCT00068692: Completed Phase 3 study of Recurrent Rectal Carcinoma and Stage IIIA Rectal Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
NCT00068692 is a Phase 3 study of Recurrent Rectal Carcinoma and Stage IIIA Rectal Cancer AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00068692, a Phase 3 study of Recurrent Rectal Carcinoma and Stage IIIA Rectal Cancer AJCC v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use 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. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer.
Primary Outcome
Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Oxaliplatin
- RADIATION Radiotherapy
- DRUG Irinotecan
- DRUG Leucovorin Calcium
Study Locations (1)
Massachusetts
- Eastern Cooperative Oncology Group - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2003-10-15 |
| Est. Completion | 2016-11-15 |
| Phase | Phase 3 |
What the finished NCT00068692 record still lists
NCT00068692 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 10 conditions, with Recurrent Rectal Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT00068692 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00068692 about?
NCT00068692 is a clinical study titled "Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer". This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as iri...
What is the current status of trial NCT00068692?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2003-10-15. Estimated completion is 2016-11-15.
What conditions does trial NCT00068692 study?
This clinical trial studies the following conditions: Recurrent Rectal Carcinoma, Stage IIIA Rectal Cancer AJCC v7, Rectal Mucinous Adenocarcinoma, Rectal Signet Ring Cell Adenocarcinoma, Stage IIA Rectal Cancer AJCC v7.
What interventions are being tested in trial NCT00068692?
The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Radiotherapy (RADIATION), Irinotecan (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT00068692?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00068692 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00068692's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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