Study on Lower-Dose Chemoradiation for Treating Early-Stage Anal Cancer (DECREASE Study)
Sponsor: ECOG-ACRIN Cancer Research Group
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
| Parameter | Options |
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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:
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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.
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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