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NCT00423293 · ClinicalTrials.gov registry record · Phase 2
Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
A Phase 2 study of Anal Cancer, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT00423293: Completed Phase 2 study of Anal Cancer, sponsored by Radiation Therapy Oncology Group.
NCT00423293 is a Phase 2 study of Anal Cancer that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 63 participants, below the 577-participant average among 19 other Anal Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423293, a Phase 2 study of Anal Cancer, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: 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. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in treating patients with invasive anal cancer.
Primary Outcome
Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.
Conditions Studied
Interventions
- RADIATION Intensity-modulated radiation therapy
- DRUG fluorouracil
- DRUG mitomycin C
Study Locations (20)
California
- Auburn Radiation Oncology - Auburn
- Providence Saint Joseph Medical Center - Burbank - Burbank
- Radiation Oncology Centers - Cameron Park - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center - Carmichael
- City of Hope Comprehensive Cancer Center - Duarte
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- Radiation Oncology Center - Roseville - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated - Sacramento
- Mercy General Hospital - Sacramento
- Solano Radiation Oncology Center - Vacaville
Colorado
- University of Colorado Cancer Center at UC Health Sciences Center - Aurora
- Penrose Cancer Center at Penrose Hospital - Colorado Springs
- Veterans Affairs Medical Center - Denver - Denver
- St. Mary - Corwin Regional Medical Center - Pueblo
Florida
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Boca Raton
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital - Fort Lauderdale
- Baptist Cancer Institute - Jacksonville - Jacksonville
Delaware
- Tunnell Cancer Center at Beebe Medical Center - Lewes
- CCOP - Christiana Care Health Services - Newark
Arizona
- Arizona Oncology - Tucson - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2006-12 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00423293 record still lists
NCT00423293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 577-participant average among 19 other Anal Cancer trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Anal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Intensity-modulated radiation therapy is the first listed.
NCT00423293 names 20 study sites across 5 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT00423293 about?
NCT00423293 is a clinical study titled "Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer". RATIONALE: 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. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either b...
What is the current status of trial NCT00423293?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2006-12. Estimated completion is 2016-12.
What conditions does trial NCT00423293 study?
This clinical trial studies the following conditions: Anal Cancer.
What interventions are being tested in trial NCT00423293?
The interventions under investigation include: Intensity-modulated radiation therapy (RADIATION), fluorouracil (DRUG), mitomycin C (DRUG).
Who is sponsoring clinical trial NCT00423293?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00423293 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00423293's enrollment target sits among peer trials
63 8th of 19 higher than 12 of 19 other Anal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anal 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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