Study on Lower-Dose Chemoradiation for Treating Early-Stage Anal Cancer (DECREASE Study)

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0

Inactive

ClinicalTrials ID:NCT04166318

This clinical trial is exploring whether a lower dose of chemotherapy combined with radiation therapy is as effective and has fewer side effects than the standard treatment for early-stage anal cancer.

Patient Parameters

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Program Overview

This study is testing if a lower dose of chemotherapy and radiation therapy can work as well as the standard higher dose in treating early-stage anal cancer. Chemotherapy drugs like mitomycin, fluorouracil, and capecitabine help stop cancer cells from growing, while radiation uses high-energy rays to kill cancer cells. The goal is to see if the lower-dose treatment can control the cancer just as effectively but with fewer side effects than the usual treatment.

Description

Primary Goals:

To see if a lower dose of chemoradiation can keep the cancer under control for at least two years in 85% or more of patients, while also improving quality of life related to bowel health, compared to the standard treatment.

Secondary Goals:

To compare changes in patient-reported outcomes, such as bowel and sexual function, between the lower-dose and standard-dose treatment groups.
To compare how often the cancer returns or spreads and overall survival rates between the two groups.
To see if using a vaginal dilator during radiation affects sexual function.
To measure changes in testosterone levels from before treatment to up to a year after radiation.
To see if certain imaging features can help identify patients who might benefit from the lower-dose treatment.
To test if an online educational tool can improve the quality of radiation targeting for anal cancer.
To find out how often and why heart-related side effects occur in patients receiving certain chemotherapy drugs.

Study Design:

Participants are randomly assigned to one of two groups:

Group A (Standard-Dose Chemoradiation):
- Receive 28 sessions of radiation therapy.
- Receive mitomycin through an IV on the first day and either fluorouracil through an IV or capecitabine pills during the radiation period.
Group B (Lower-Dose Chemoradiation):
- Receive 20 or 23 sessions of radiation therapy.
- Receive mitomycin through an IV on the first day and either fluorouracil through an IV or capecitabine pills during the radiation period.

After treatment, patients will have follow-up visits at 6 weeks, every 3 months for the first 2 years, every 6 months in the third year, and annually for years 4 and 5.

Eligibility Criteria

Inclusion Criteria

Must have a confirmed diagnosis of early-stage anal cancer (T1-2N0M0) with tumors 4 cm or smaller.
Must not have lymph nodes that appear to be involved with cancer based on imaging tests.
Must be HIV-negative or, if HIV-positive, have a CD4 count of 300 or higher and no lymph node involvement.
Must have a performance status score of 0-2, indicating good overall health.
Must not have had previous radiation or chemotherapy for anal cancer.
Must not have had major surgery to remove anal cancer.
Must not be receiving other cancer treatments during the study.
Must not have serious health conditions that would interfere with the study.
Must not have had significant heart problems within 6 months before joining the study.
Must not have another type of cancer unless it has been in remission for at least 2 years.
Must not have active autoimmune or connective tissue diseases.
Must not be on certain blood thinners if taking capecitabine.
Must have adequate blood counts and organ function based on specific tests.
Women must not be pregnant or breastfeeding and must use effective birth control during the study and for 6 months after treatment.
Men must also use effective birth control during the study and for 6 months after treatment.

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