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NCT04929028 · ClinicalTrials.gov registry record · Phase 2
Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer
A Phase 2 study of HIV Infection and Stage III Rectal Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 14
- Study locations
NCT04929028: Recruiting Phase 2 study of HIV Infection and Stage III Rectal Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04929028 is a Phase 2 study of HIV Infection and Stage III Rectal Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04929028, a Phase 2 study of HIV Infection and Stage III Rectal Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, 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. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.
Primary Outcome
Evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The adverse events will be summarized by overall, as well as by grade using frequency (percentage). A two-sided 95% confidence interval will be reported together with percentage estimates. The proportion of participants who experience grade 3-4 toxicities will be estimated using a binomial point estimate and its 95% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- PROCEDURE Anoscopy
- PROCEDURE Colonoscopy
Study Locations (14)
New York
- Mount Sinai West - New York
- Icahn School of Medicine at Mount Sinai - New York
- Mount Sinai Hospital - New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Texas
- Lyndon Baines Johnson General Hospital - Houston
- M D Anderson Cancer Center - Houston
California
- Zuckerberg San Francisco General Hospital - San Francisco
District of Columbia
- George Washington University Medical Center - Washington D.C.
Florida
- Moffitt Cancer Center - Tampa
Illinois
- University of Illinois - Chicago
Missouri
- Washington University School of Medicine - St Louis
Pennsylvania
- Pennsylvania Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-08-09 |
| Est. Completion | 2031-09-15 |
| Phase | Phase 2 |
What NCT04929028 shows while recruiting
NCT04929028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower).
The record links to 10 conditions, with HIV Infection appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04929028 lists 14 locations in 9 states (New York, Texas, California).
Frequently Asked Questions
What is clinical trial NCT04929028 about?
NCT04929028 is a clinical study titled "Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer". This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer...
What is the current status of trial NCT04929028?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-08-09. Estimated completion is 2031-09-15.
What conditions does trial NCT04929028 study?
This clinical trial studies the following conditions: HIV Infection, Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Anal Squamous Cell Carcinoma, Anal Margin Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04929028?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Anoscopy (PROCEDURE), Colonoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT04929028?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04929028 being conducted?
This trial has 14 study locations across California, District of Columbia, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04929028's enrollment target sits among peer trials
40 45th of 73 higher than 28 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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