Trials / Active Not Recruiting

Active Not RecruitingNCT04166318

Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study

A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 252 (estimated)

Sponsor: ECOG-ACRIN Cancer Research Group · Network
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

Detailed description

PRIMARY OBJECTIVE: I. To determine whether de-intensified chemoradiation for early stage squamous cell carcinoma of the anal canal (SCCA) is able to maintain excellent 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose chemoradiation therapy (CRT), as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year. SECONDARY OBJECTIVES: I. To compare changes in patient-reported HRQL (as per Fecal Incontinence Severity Index \[FISI\], Patient Reported Outcomes Measurement Information System \[PROMIS\], International Index of Erectile Function \[IIEF\], Sexual Function-Vaginal Changes Questionnaire \[SVQ\], and Vaginal Assessment Scale \[VAS\]/Vulvar Assessment Scale \[VuAS\] instruments) between the experimental and control arm. II. To compare patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation), disease control, and overall survival between experimental and control arm. III. To correlate vaginal dilator use during radiation delivery with sexual function. IV. To measure changes in serum total testosterone from baseline to up to 12 months after radiation. V. To validate the utility of imaging features of inguinal and pelvic lymph nodes obtained prior to treatment as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified chemoradiation is appropriate. VI. To determine the incidence of and predictors for cardiovascular toxicity in patients receiving fluorouracil (5-FU) or capecitabine. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (STANDARD-DOSE CHEMORADIATION): Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin intravenously (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 orally (PO) twice daily (BID) 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity. ARM B (DE-INTENSIFIED CHEMORADIATION): 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. All patients receive fludeoxyglucose F-18 (FDG) and undergo positron emission tomography (PET)/magnetic resonance imaging (MRI) or receive FDG and undergo PET/computed tomography (CT) during baseline. Patients undergo CT or MRI on the trial. Patients also undergo tissue biopsy during screening and at the discretion of the treating physician. Additionally, patients undergo blood sample collection throughout the trial. After completion of study treatment, patients are followed up at 6 weeks, every 3 months for years 1-2, every 6 months for year 3, then annually for years 4-5.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo tissue biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DRUG	Capecitabine	Given PO
PROCEDURE	Computed Tomography	Undergo PET/CT
OTHER	Fludeoxyglucose F-18	Receive FDG
DRUG	Fluorouracil	Given IV
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MRI
DRUG	Mitomycin	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2020-01-02
Primary completion: 2029-12-31
Completion: 2029-12-31
First posted: 2019-11-18
Last updated: 2026-03-23

Locations

659 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04166318. Inclusion in this directory is not an endorsement.