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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
Must not have
Patients will be considered to be lymph node (LN) positive and thereby not eligible in this study if the lymph nodes meet any of the following criteria:
External Iliac and common Iliac:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lymph nodes do not make me ineligible for this study.
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This criterion does not provide enough context for a summary.
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My MRI shows my lesion has an irregular border or a dead tissue center.
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My groin lymph nodes were checked and are not cancerous.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in FIQoL in the de-intensified CRT arm
Disease control in the de-intensified chemoradiation therapy (CRT) arm
Secondary study objectives
Changes in patient-reported outcomes - Anal Discomfort/pain (PROMIS- Full)
Changes in patient-reported outcomes - Fecal Incontinence Severity Index [FISI]
Changes in patient-reported outcomes - HRQL: Health Related Quality of Life FACT-G (Functional Assessment of Cancer Therapy-General)
+13 more
Other study objectives
Overall survival

Awards & Highlights

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.

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
Capecitabine
FDA approved
Fluorouracil
FDA approved
Mitomycin
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,893 Previous Clinical Trials
41,012,220 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
120 Previous Clinical Trials
179,625 Total Patients Enrolled
Jennifer A DorthPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04166318 — Phase 2
Anal Cancer Research Study Groups: Arm B (de-intensified chemoradiation), Arm A (standard-dose chemoradiation)
Anal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04166318 — Phase 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166318 — Phase 2
~131 spots leftby Dec 2029
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