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

Running, not enrolling · Phase 2

Conditions studied: Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Anal Canal Squamous Cell Carcinoma, Anal Margin Squamous Cell Carcinoma, Stage I Anal Cancer AJCC v8, Stage IIA Anal Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT04166318
Run by: ECOG-ACRIN Cancer Research Group
People needed: 252
Starts: 2020-01-02
Expected to finish: 2029-12-31
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

STEP 0 (PRE-REGISTRATION)
Patient must be ≥ 18 years of age
Patients must be English speaking to participate in the trial. (Please note that this requirement is due to the fact that the quality-of-life studies are mandatory and we currently do not have full translated versions of the questionnaires into other languages)
Patient must have histologically proven T1-2N0M0 invasive anal canal or anal margin squamous cell carcinoma with tumors measuring =< 4 cm. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Measurable disease is not required
Patients who are status/post local excision or excisional biopsy procedure are eligible provided there was tumor involvement of the anal canal and/or anal verge prior to the reaction, if the margins were positive, and/or if the stage is T2N0 based on tumor size before the procedure. This means that patients with T1N0M0 anal margin squamous cell carcinoma who underwent surgical excision with negative margins and no involvement of the anal verge and/or anal canal are not eligible
Tumor size must be documented based on physical examination including digital rectal exam and/or anoscopy/proctoscopy within 4 weeks prior to Step 0 pre-registration
Patient's human immunodeficiency virus (HIV) status must be known and documented at baseline
NOTE: For patients without a history of HIV infection, it is recommended (but not required) that updated HIV testing be performed within one year of study enrollment
Patients who are HIV-negative will be registered to Arm R. They must not have lymph nodes that are radiographically-concerning for cancer involvement using computed tomography (CT) and fludeoxyglucose F-18 (FDG) - positron emission tomography (PET)/CT-based criteria
NOTE: Patients who are HIV-negative and meet the below criteria may proceed directly to Step 1 Randomization
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:
Mesorectal, presacral, internal iliac or obturator LN with:
Short axis measuring > 5 mm based on CT/magnetic resonance imaging (MRI) OR
Morphologic features of irregular border or central necrosis if assessed on MRI and LN measures > 3 mm OR
FDG uptake > blood pool (Deauville 3-5) based on FDG-PET/CT or PET/MRI
Internal Iliac and obturator LN with:
Short-axis measuring > 7 mm based on CT/MRI OR
Morphologic features of irregular border or central necrosis based on CT/MRI OR
FDG uptake > blood pool (Deauville 3-5) based on FDG-PET/CT or PET/MRI
External Iliac and common Iliac:
Short-axis measuring > 10 mm based on CT/MRI OR
Morphologic features of irregular border or central necrosis based on CT/MRI OR
FDG uptake > blood pool (Deauville 3-5) based on FDG-PET/CT or PET/MRI
Inguinal LN (superficial and deep) meeting any of the following criteria will be ineligible unless an fine needle aspiration (FNA) is performed and resulting cytology is negative.
Morphologic features of irregular border or central necrosis based on CT/MRI

Where it is running

Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States
Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
Alaska Women's Cancer Care — Anchorage, Alaska, United States
Anchorage Oncology Centre — Anchorage, Alaska, United States
Katmai Oncology Group — Anchorage, Alaska, United States
Providence Alaska Medical Center — Anchorage, Alaska, United States
Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
Kingman Regional Medical Center — Kingman, Arizona, United States
Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States
PCR Oncology — Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
Mercy Cancer Center - Carmichael — Carmichael, California, United States
Mercy San Juan Medical Center — Carmichael, California, United States
Mercy Cancer Center - Elk Grove — Elk Grove, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
UC San Diego Moores Cancer Center — La Jolla, California, United States
Contra Costa Regional Medical Center — Martinez, California, United States
Mercy Cancer Center — Merced, California, United States
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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