At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 63 enrolled

Drug / intervention

fluorouracil +2 moredrug

Likely dose

fluorouracil 1000 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00423293

NCT00423293Phase 2Completed

Compare CT.gov

A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal

Radiation Therapy Oncology Group·interventional·Posted Jan 18, 2007·Updated Feb 27, 2019

In Brief

A Phase 2 clinical trial evaluating fluorouracil, mitomycin C, and 1 other intervention for Anal Cancer. Completed, enrolled 63 participants across 172 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnal Cancer

CountriesCanada, United States

CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2006

First PostedJan 2007

Primary CompletionFeb 2009

Study CompletionDec 2016

TodayJul 2026

First PostedJan 18, 2007

Enrollment StartDec 1, 2006

Primary CompletionFeb 1, 2009

Study CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 19.5 years ago

Interventions

fluorouracildrug

1000 mg/m\^2/day 96-hour continous infusion (M-F) starting on day 1 and again on day 29 of radiation therapy.

mitomycin Cdrug

10 mg/m\^2 intravenous therapy on day 1 and day 29 of radiation therapy.

Intensity-modulated radiation therapyradiation

Prescription dose depends on tumor staging. T2N0: The primary tumor PTV (planning target volume) (PTVA) receives 50.4 Gy in 28 fractions (fx) at 1.8 Gy/fx. The nodal PTVs receive 42 Gy in 28 fx at 1.5 Gy/fx. PTVA receive 50.4 Gy in 28 fractions at 1.8 Gy/fx. PTV42 receive 42 Gy in 28 fx at 1.5 Gy/fx and will include all nodal regions. T3N0 or T4N0: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. The nodal PTVs will receive 45 Gy in 30 fx at 1.5 Gy/fx. PTVA will receive 54 Gy in 30 fx at 1.80 Gy/fx. PTV45 will receive 45 Gy in 30 fx electively at 1.5 Gy/fx and will include all nodal regions. For N+ disease: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. For involved nodes ≤ 3 cm in maximum dimension, the involved nodal PTV will receive 50.4 Gy in 30 fx at 1.68 Gy/fx. For involved nodes \> 3 cm in maximum dimension, the involved nodal PTV will receive 54 Gy in 30 fx at 1.80 Gy/fx.