Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00613080 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT00613080: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00613080 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613080, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.
Primary Outcome
The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events \<= 90 days from the start of concurrent treatment are included.
Interventions
- DRUG FOLFOX
- DRUG oxaliplatin
- DRUG capecitabine
- RADIATION radiation therapy
- PROCEDURE resection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2008-04 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00613080 record still lists
NCT00613080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 5 interventions - of which FOLFOX is the first listed.
NCT00613080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00613080 about?
NCT00613080 is a clinical study titled "Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to...
What is the current status of trial NCT00613080?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2008-04. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00613080?
The interventions under investigation include: FOLFOX (DRUG), oxaliplatin (DRUG), capecitabine (DRUG), radiation therapy (RADIATION), resection (PROCEDURE).
Who is sponsoring clinical trial NCT00613080?
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 NCT00613080's enrollment target sits among peer trials
79 884th of 2000 higher than 1,117 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
- NCT05798897 · 79 participants · Phase 1
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
- NCT06042439 · 79 participants · NA
AM vs PM Exercise Training
- NCT06223555 · 79 participants · NA
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
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