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NCT05610163 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation
A Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 783
- Enrollment target
- 20
- Study locations
NCT05610163: Active Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
NCT05610163 is a Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8 that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 783 participants, above the 64-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (1123% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05610163, a Phase 2 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 783 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Primary Outcome
Defined as the number of patients who achieved cCR at the end of total neoadjuvant therapy (TNT) divided by number of patients included in the analysis population. This endpoint will be assessed within 8-12 weeks after completion of TNT. If there is a cCR, then the patient will be counted in the numerator. If there is a near-complete response (nCR) then a re-evaluation within 4-8 weeks will be performed. If an nCR evolved to a cCR, then the patient will be counted in the numerator. Otherwise, th
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG 5-fluorouracil
- DRUG Leucovorin calcium
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - 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
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Keck Medicine of USC Buena Park - Buena Park
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mercy Cancer Center - Carmichael - Carmichael
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 783 participants |
| Start Date | 2022-12-08 |
| Est. Completion | 2033-09-30 |
| Phase | Phase 2 |
What the registry record for NCT05610163 still lists
NCT05610163 is an interventional study that assigns participants to a tested intervention. The registered 783 participants enrollment target is mid-sized for trials with a published cap, above the 64-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (1123% higher).
The record links to 3 conditions, with Stage III Rectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05610163 names 20 study sites across 5 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05610163 about?
NCT05610163 is a clinical study titled "Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation". This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxalipl...
What is the current status of trial NCT05610163?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 783 participants. The study started on 2022-12-08. Estimated completion is 2033-09-30.
What conditions does trial NCT05610163 study?
This clinical trial studies the following conditions: Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Locally Advanced Rectal Carcinoma.
What interventions are being tested in trial NCT05610163?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), 5-fluorouracil (DRUG), Leucovorin calcium (DRUG).
Who is sponsoring clinical trial NCT05610163?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05610163 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.
Learn More About Clinical Trials
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Where NCT05610163's enrollment target sits among peer trials
783 1st of 15 higher than 15 of 15 other Stage III Rectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Rectal Cancer AJCC v8 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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