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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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