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Anti-metabolites
Reduced-Intensity Chemoradiation for Anal Cancer
Phase 2
Recruiting
Led By Jennifer A Dorth
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus
Patient must have histologically proven T1-2N0M0 invasive anal canal or anal margin squamous cell carcinoma with tumors measuring =< 4 cm within 4 weeks prior to randomization. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Patients with T1N0M0 anal margin squamous cell carcinoma who underwent surgical excision with negative margins are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well lower-dose chemotherapy + radiation works to treat patients with early-stage anal cancer, compared to standard-dose chemoradiation.
Who is the study for?
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.Check my eligibility
What is being tested?
The DECREASE Study is testing whether lower-dose chemoradiation therapy is as effective as the standard dose for treating early-stage anal cancer. It involves drugs like mitomycin, fluorouracil, capecitabine combined with intensity-modulated radiation therapy to see if it reduces side effects while still being effective.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, skin changes at the radiation site, low blood counts leading to increased infection risk, mouth sores from chemotherapy drugs and possible diarrhea due to capecitabine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had surgery aimed at curing anal cancer.
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My anal cancer is early stage, hasn't spread, and the tumor is 4 cm or smaller.
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My lymph nodes do not show signs of cancer based on specific imaging tests.
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I am HIV-negative and my scans do not show cancer in my lymph nodes.
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I have not had radiation or chemotherapy for my cancer.
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I am not taking any other cancer treatments or experimental drugs with the study drugs.
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I do not have an active autoimmune or connective tissue disease.
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I can take care of myself and am up and about more than half of the day.
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I had surgery to remove a tumor in my anal canal or verge.
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I haven't had serious heart problems in the last 6 months.
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My scans show no cancer in my lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FIQoL in the de-intensified CRT arm
Disease control in the de-intensified chemoradiation therapy (CRT) arm
Secondary outcome measures
Change in serum total testosterone
Changes in patient-reported outcomes - Anal Discomfort/pain (PROMIS- Full)
Changes in patient-reported outcomes - Fecal Incontinence Severity Index [FISI]
+14 moreOther outcome measures
Overall survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (de-intensified chemoradiation)Experimental Treatment6 Interventions
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.
Group II: Arm A (standard-dose chemoradiation)Active Control6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Fluorouracil
FDA approved
Capecitabine
FDA approved
Mitomycin
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,964,806 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,670 Total Patients Enrolled
Jennifer A DorthPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer involves specific lymph nodes near the rectum.My lymph nodes do not make me ineligible for this study.My anal cancer is early stage, hasn't spread, and the tumor is 4 cm or smaller.I am willing to switch from warfarin to another blood thinner if I decide to use capecitabine.I am HIV-negative and my cancer may not have spread to my lymph nodes.My cancer has no lymph node involvement confirmed by central imaging.I take Dilantin for seizures and will have its levels checked weekly if I receive capecitabine.I am HIV-negative and had a negative biopsy for my inguinal lymph nodes.I am on low molecular weight heparin and my blood clotting time is normal.I have not had surgery aimed at curing anal cancer.My lymph nodes do not show signs of cancer based on specific imaging tests.I am HIV-negative and my scans do not show cancer in my lymph nodes.I have not had radiation or chemotherapy for my cancer.I am not taking any other cancer treatments or experimental drugs with the study drugs.This criterion does not provide enough context for a summary.I have been cancer-free from another type for over 2 years and considered low risk for its return.I do not have an active autoimmune or connective tissue disease.I am HIV-positive with a CD4 count of 300 or more and no lymph node involvement.I can take care of myself and am up and about more than half of the day.I switched from warfarin to another blood thinner because I'm considering capecitabine.My MRI shows my lesion has an irregular border or a dead tissue center.I am not pregnant or breastfeeding and have confirmed this with a test.I had surgery to remove a tumor in my anal canal or verge.I was diagnosed and treated for early-stage cervical, basal cell, or squamous cell skin cancer within the last 5 years.I haven't had serious heart problems in the last 6 months.My kidney function tests are within normal limits.My groin lymph nodes were checked and are not cancerous.My scans show no cancer in my lymph nodes.I am committed to using effective birth control or abstaining from sex for 6 months after treatment ends.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (de-intensified chemoradiation)
- Group 2: Arm A (standard-dose chemoradiation)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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