Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00081289 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
NCT00081289: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00081289 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 146 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081289, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in 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. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
Primary Outcome
A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR. Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%,
Interventions
- DRUG Oxaliplatin
- RADIATION Radiation Therapy
- DRUG Irinotecan
- DRUG Capecitabine 1650 mg/m^2/day
- DRUG Capecitabine 1200 mg/m^2/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2004-03 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00081289 record still lists
NCT00081289 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT00081289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00081289 about?
NCT00081289 is a clinical study titled "Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer". RATIONALE: Drugs used in chemotherapy work in 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. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that i...
What is the current status of trial NCT00081289?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2004-03. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00081289?
The interventions under investigation include: Oxaliplatin (DRUG), Radiation Therapy (RADIATION), Irinotecan (DRUG), Capecitabine 1650 mg/m^2/day (DRUG), Capecitabine 1200 mg/m^2/day (DRUG).
Who is sponsoring clinical trial NCT00081289?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00081289's enrollment target sits among peer trials
146 496th of 2000 higher than 1,503 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03490929 · 146 participants · Phase 4
CEUS for Blunt Abdominal Trauma in Children
- NCT04755062 · 146 participants · NA
A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans
- NCT04867954 · 146 participants
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
- NCT05051618 · 146 participants · NA
Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia