Brief Summary

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

252

participants targeted

Target at P75+ for phase_2

Timeline

45mo left

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach

1 country

659 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 years study duration

Study Progress63%

Jan 2020Dec 2029

First Submitted

Initial submission to the registry

November 6, 2019

Completed

12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed

10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

November 6, 2019

Last Update Submit

March 19, 2026

Conditions

Anal Basaloid Carcinoma Anal Canal Cloacogenic Carcinoma Anal Margin Squamous Cell Carcinoma Stage I Anal Cancer AJCC v8 Stage IIA Anal Cancer AJCC v8 Anal Canal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

Disease control in the de-intensified chemoradiation therapy (CRT) arm
An event is local-regional failure, distant metastasis and chemoradiation-related death. Will determine if de-intensified chemoradiation achieves 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose CRT, as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year. The co-primary endpoints of disease control and FIQoL will be formally assessed in a hierarchical manner with disease control being assessed first. Will be estimated for all treatment arms using the Kaplan-Meier method (1958).
Up to 2 years
Change in FIQoL in the de-intensified CRT arm
Quality of life analyses, will be compared between arms using a two-sample independent t-tests at a significance level of 0.05 and appropriate longitudinal models will be evaluated to assess the trajectory of HRQL endpoints over time and to evaluate those trajectories between treatment arms. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.
Baseline up to 1 year

Secondary Outcomes (7)

Changes in patient-reported outcomes
Baseline up to 5 years
Patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation)
Up to 5 years
Disease control
Up to 5 years
Effect of vaginal dilator use during radiation delivery on sexual function
Up to 5 years
Change in serum total testosterone
Baseline up to 12 months after radiation
+2 more secondary outcomes

Other Outcomes (1)

Overall survival
Up to 5 years

Study Arms (2)

Arm A (standard-dose chemoradiation)

ACTIVE COMPARATOR

Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 and 29-32 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/MRI or receive FDG and undergo PET/CT during baseline. Patients undergo CT or MRI on the trial. Patients also undergo tissue biopsy during screening and at the discretion of the treating physician. Additionally, patients undergo blood sample collection throughout the trial.

Procedure: BiopsyProcedure: Biospecimen CollectionDrug: CapecitabineProcedure: Computed TomographyOther: Fludeoxyglucose F-18Drug: FluorouracilRadiation: Intensity-Modulated Radiation TherapyProcedure: Magnetic Resonance ImagingDrug: MitomycinProcedure: Positron Emission TomographyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm B (de-intensified chemoradiation)

EXPERIMENTAL

Patients undergo 20 or 23 fractions of IMRT. Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/MRI or receive FDG and undergo PET/CT during baseline. Patients undergo CT or MRI on the trial. Patients also undergo tissue biopsy during screening and at the discretion of the treating physician. Additionally, patients undergo blood sample collection throughout the trial.