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Clinical Trials in Israel / NCT04166318
Active, not recruiting Phase 2

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

NCT04166318 · tracked via the Priya Life Science Israel tracker
Phase
Phase 2
Started
2020-01-02
Last updated
2026-09-14

Condition(s) studied

Anal Basaloid CarcinomaAnal Canal Cloacogenic CarcinomaAnal Canal Squamous Cell CarcinomaAnal Margin Squamous Cell CarcinomaStage I Anal Cancer AJCC v8Stage IIA Anal Cancer AJCC v8

Investigational drug(s) / intervention(s)

BiopsyBiospecimen CollectionCapecitabine →Computed TomographyFludeoxyglucose F-18Fluorouracil →Intensity-Modulated Radiation TherapyMagnetic Resonance ImagingMitomycin →Positron Emission TomographyQuality-of-Life AssessmentQuestionnaire Administration

Biopsy: Undergo tissue biopsy

Biospecimen Collection: Undergo blood sample collection

Capecitabine: Given PO

Computed Tomography: Undergo PET/CT

Fludeoxyglucose F-18: Receive FDG

Fluorouracil: Given IV

Intensity-Modulated Radiation Therapy: Undergo IMRT

Magnetic Resonance Imaging: Undergo PET/MRI

Mitomycin: Given IV

Positron Emission Tomography: Undergo PET/CT

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * FDG uptake \> liver (Deauville 4) based on FDG-PET/CT. * Patients who are HIV-negative and have inguinal lymph nodes that do not meet the above criteria must undergo fine needle aspiration and have negative histology to be eligible * Patients who are HIV-positive will be registered to Arm S. They must meet the eligibility criteria below: * A CD4 count \>= 200 * Imaging submitted to ECOG-ACRIN for central review for confirmation of no lymph node involvement * No history of acquired immunodeficiency syndrome (AIDS)-related complications within past year other than a history of low CD4+ T-cell count (\> 200/mm\^3) prior to initiation of combination antiretroviral therapy * Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer * Patient MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Patients will be eligible regardless of antiretroviral medication provided the regimen has been stable for at least 4 weeks * STEP 1 RANDOMIZATION * Patient must have met the eligibility criteria as outlined Step 0 Pre-registration * Patient must have Eastern Cooperative Oncology Group (ECOG) - American College of Radiology Imaging Network (ACRIN) performance status of 0-2 * Patient must have no history of prior chemotherapy for this malignancy * Patients must not have undergone previous radiation to the pelvis such that overlapping radiation fields would be expected * Patient must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus. However, patients who undergo local excision or excisional biopsy are eligible provided they meet inclusion criteria * Patients with T1N0M0 anal margin squamous cell carcinoma must not have undergone surgical excision with negative margins and no involvement of the anal verge and/or anal canal * Patient must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs * Patient must not have intercurrent illness including, but not limited to, ongoing or active infection or psychiatric/social situations that, in the judgement of the investigator, would limit compliance with study requirements * Patient must not have had significant cardiovascular disease including myocardial infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary artery disease, symptomatic congestive heart failure, or uncontrolled cardiac arrhythmia within 6 months of Step 1 randomization * Patient must not have a history of a different malignancy unless they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk of recurrence * Exceptions to this rule are individuals with cervical cancer in situ, non-melanoma skin cancers, and colon polyps * Patient must not have active inflammatory bowel disease (patients requiring current medical interventions or who are symptomatic) * Patients must not have an active autoimmune or connective tissue disease that has required systemic treatment in the past two years (i.e., with the use of modifying agents, corticosteroids, or immunosuppressive drugs) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Patients who are on anti-coagulation with warfarin within 2 weeks prior to Step 1 randomization and are considering the use of capecitabine, must use an alternative anti-coagulant * NOTE: Low molecular weight heparin is permitted provided the patient's prothrombin time (PT)/international normalized ratio (INR) is \< 1.5 * Patients who will receive capecitabine and are on Dilantin for a seizure disorder must have Dilantin levels checked weekly * Hemoglobin \> 10 g/dL (within 2 weeks prior to Step 1 Randomization) * Platelets \>= 100,000/mm\^3 (within 2 weeks prior to Step 1 Randomization) * Absolute neutrophil count \>= 1500/mm\^3 (within 2 weeks prior to Step 1 Randomization) * Serum creatinine must be \< 1.5 X upper limit of normal (ULN), or calculated creatinine clearance must be \> 50 ml/min (within 2 weeks prior to Step 1 Randomization) * Total bilirubin must be \< 2 X ULN (within 2 weeks prior to Step 1 Randomization) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 X institutional ULN (within 2 weeks prior to Step 1 Randomization) * Albumin \>= 3.0 g/dL (within 2 weeks prior to Step 1 Randomization) * Women must not be pregnant or breast-feeding because the study treatment administered may cause harm to an unborn fetus or breastfeeding child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to Step 1 Randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential and sexually active males must be strongly advised to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for at least 6 months after the completion of treatment

Primary outcome measure(s)

Trial sites (659)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
Kingman Regional Medical Center Kingman Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
PCR Oncology Arroyo Grande California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Mercy Cancer Center - Carmichael Carmichael California
Mercy San Juan Medical Center Carmichael California
Mercy Cancer Center - Elk Grove Elk Grove California
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California
UC San Diego Moores Cancer Center La Jolla California
Contra Costa Regional Medical Center Martinez California
Mercy Cancer Center Merced California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
Stanford Cancer Institute Palo Alto Palo Alto California
Mercy Cancer Center - Rocklin Rocklin California
Mercy Cancer Center - Sacramento Sacramento California
UC San Diego Medical Center - Hillcrest San Diego California
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
Mission Hope Medical Oncology - Santa Maria Santa Maria California
Woodland Memorial Hospital Woodland California
Rocky Mountain Cancer Centers-Aurora Aurora Colorado
UCHealth University of Colorado Hospital Aurora Colorado
Rocky Mountain Cancer Centers-Boulder Boulder Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado
Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
UCHealth Memorial Hospital Central Colorado Springs Colorado
Memorial Hospital North Colorado Springs Colorado

+ 619 more sites — see the full list on the official registry below.

More ECOG-ACRIN Cancer Research Group trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04166318 on ClinicalTrials.gov ↗ ← All trials in Israel