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COMPLETED Phase 2

Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

NCT00423293 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 63 participants
Start Date 2006-12
Est. Completion 2016-12
Phase Phase 2

Sponsor

Radiation Therapy Oncology Group

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00423293

The ClinicalTrials.gov registry entry for NCT00423293 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00423293 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00423293?

The interventions under investigation include: Intensity-modulated radiation therapy (RADIATION), fluorouracil (DRUG), mitomycin C (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00423293?

This trial is sponsored by Radiation Therapy Oncology Group, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial