Reduced-Intensity Chemoradiation for Anal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a lower-dose combination of chemotherapy and radiation is as effective as the usual higher-dose treatment for early-stage anal cancer. The goal is to determine if the lower-dose approach can reduce side effects while effectively stopping the cancer. Participants will receive either the standard or reduced dose of chemotherapy drugs like mitomycin and fluorouracil, along with targeted radiation. This trial suits individuals with early-stage anal cancer who do not have severe health issues or prior extensive cancer treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on warfarin and considering capecitabine, you must switch to a different blood thinner. Also, if you are taking Dilantin for seizures and will receive capecitabine, your Dilantin levels need to be checked weekly.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments in this trial have been used safely in people before. Studies indicate that capecitabine and fluorouracil, both chemotherapy drugs, have been effective with fewer side effects compared to some other treatments. In research on rectal cancer, capecitabine had similar effects to fluorouracil but caused fewer side effects, such as nausea or hand-foot syndrome, which causes redness and swelling in the hands and feet.
Mitomycin, another chemotherapy drug in the trial, has also been used safely in many patients. One study found that patients responded well to treatment with manageable side effects. Some patients experienced low blood cell counts, but this was expected and managed during treatment.
Intensity-Modulated Radiation Therapy (IMRT), a type of targeted radiation, has also proven safe. It focuses more precisely on the tumor, reducing harm to nearby healthy tissue. Studies show that IMRT can lead to fewer severe side effects compared to older radiation methods.
Overall, these treatments have been used before and are generally well-tolerated. However, like all treatments, there is still a risk of side effects. Participants should talk to their doctors to fully understand these risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the reduced-intensity chemoradiation regimen for anal cancer because it offers a potentially less taxing treatment option while maintaining effectiveness. Unlike the standard regimen, which typically involves a higher dose of chemoradiation, this approach uses fewer radiation fractions and a potentially less intense chemotherapy schedule. This could mean fewer side effects for patients and a more manageable treatment experience, which is especially important for those who may not tolerate the standard regimen well. By using intensity-modulated radiation therapy (IMRT) alongside either fluorouracil or capecitabine, the treatment aims to precisely target cancer cells and minimize damage to surrounding healthy tissue.
What evidence suggests that this trial's treatments could be effective for anal cancer?
This trial compares two chemoradiation approaches for anal cancer. In Arm A, participants receive standard-dose chemoradiation, which includes intensity-modulated radiation therapy (IMRT) combined with either capecitabine or fluorouracil, and mitomycin. In Arm B, participants receive a de-intensified version of this treatment. Studies have shown that combining chemotherapy and radiation effectively treats anal cancer. Capecitabine and fluorouracil stop cancer cells from growing and spreading. Research suggests that adding mitomycin enhances the treatment's effectiveness. IMRT has improved survival rates and shortened treatment time for anal cancer patients. Overall, these treatments work together to kill more cancer cells and may lead to better outcomes.14678
Who Is on the Research Team?
Jennifer A Dorth
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with early-stage anal cancer (T1-2N0M0) and tumors <=4 cm, who haven't had prior radiation or chemotherapy. HIV-positive patients must have a CD4 count >=300 without lymph node involvement. Participants need good organ function and can't be pregnant or breastfeeding. They should not have other serious illnesses or recent cardiovascular events.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard-dose or de-intensified chemoradiation therapy, including mitomycin and either fluorouracil or capecitabine, alongside intensity-modulated radiation therapy (IMRT).
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 6 weeks, every 3 months for years 1-2, every 6 months for year 3, then annually for years 4-5.
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Fluorouracil
- Intensity-Modulated Radiation Therapy
- Mitomycin
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator