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NCT02912559 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
A Phase 3 study of Lynch Syndrome and Colon Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 712
- Enrollment target
- 20
- Study locations
NCT02912559: Active Phase 3 study of Lynch Syndrome and Colon Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT02912559 is a Phase 3 study of Lynch Syndrome and Colon Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 712 participants, below the 2,282-participant average among 21 other Lynch Syndrome trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02912559, a Phase 3 study of Lynch Syndrome and Colon Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 712 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, 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. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.
Primary Outcome
DFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test. The hazard ratio (HR) for DFS will be estimated using a stratified Cox proportional hazards model and the 95 percent confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will a
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Atezolizumab
- DRUG 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
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 712 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2026-12-18 |
| Phase | Phase 3 |
What the registry record for NCT02912559 still lists
NCT02912559 is an interventional study that assigns participants to a tested intervention. The registered 712 participants enrollment target is mid-sized for trials with a published cap, below the 2,282-participant average among 21 other Lynch Syndrome trials with a reported enrollment target (69% lower).
The record links to 4 conditions, with Lynch Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02912559 names 20 study sites across 4 states, led by Alaska, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT02912559 about?
NCT02912559 is a clinical study titled "Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair". This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxa...
What is the current status of trial NCT02912559?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 712 participants. The study started on 2017-10-16. Estimated completion is 2026-12-18.
What conditions does trial NCT02912559 study?
This clinical trial studies the following conditions: Lynch Syndrome, Colon Adenocarcinoma, Stage III Colon Cancer AJCC V8, DNA Repair Disorder.
What interventions are being tested in trial NCT02912559?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Fluorouracil (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT02912559?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02912559 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lynch Syndrome
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 NCT02912559's enrollment target sits among peer trials
712 7th of 21 higher than 15 of 21 other Lynch Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lynch Syndrome 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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