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NCT04166318 · ClinicalTrials.gov registry record · Phase 2
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
A Phase 2 study of Anal Margin Squamous Cell Carcinoma and Anal Basaloid Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 252
- Enrollment target
- 20
- Study locations
NCT04166318 is a Phase 2 study of Anal Margin Squamous Cell Carcinoma and Anal Basaloid Carcinoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 252 participants. The trial reports 20 study locations across 5 states.
The verdict
NCT04166318, a Phase 2 study of Anal Margin Squamous Cell Carcinoma and Anal Basaloid Carcinoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 252 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- PROCEDURE Biopsy
- OTHER Fludeoxyglucose F-18
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2020-01-02 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04166318
The ClinicalTrials.gov registry entry for NCT04166318 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Anal Margin Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04166318 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04166318 about?
NCT04166318 is a clinical study titled "Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study". 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...
What is the current status of trial NCT04166318?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2020-01-02. Estimated completion is 2029-12-31.
What conditions does trial NCT04166318 study?
This clinical trial studies the following conditions: Anal Margin Squamous Cell Carcinoma, Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Stage I Anal Cancer AJCC v8, Anal Canal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04166318?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Biopsy (PROCEDURE), Fludeoxyglucose F-18 (OTHER).
Who is sponsoring clinical trial NCT04166318?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04166318 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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