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NCT02008656 · ClinicalTrials.gov registry record · Phase 2
Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
A Phase 2 study of Rectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 358
- Enrollment target
- 20
- Study locations
NCT02008656: Active Phase 2 study of Rectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02008656 is a Phase 2 study of Rectal Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 358 participants, below the 3,162-participant average among 70 other Rectal Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02008656, a Phase 2 study of Rectal Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 358 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is designed to test the hypothesis that patients with Locally advanced rectal cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT), Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).
Primary Outcome
3-year DFS will be defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of randomization
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG 5-Fluorouracil (5-FU)
- DRUG Oxaliplatin (OXAL)
- DRUG Capecitabine (Xeloda®)
- RADIATION intensity modulated radiotherapy (IMRT)
Study Locations (20)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- University of Rochester Medical Center - Rochester
- Memorial Sloan Kettering Cancer Center at Phelps - Sleepy Hollow
California
- University of California, Irvine - Irvine
- St. Joseph Hospital - Orange
- University of California San Francisco - San Francisco
- John Muir Health - Walnut Creek
Florida
- University Of South Florida - Tampa
- Cleveland Clinic Florida - Weston
Nebraska
- CHI Heath Bergan Mercy - Omaha
- Colon and Rectal Surgery, Incorporated - Omaha
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Bergen - Montvale
Colorado
- University of Colorado - Aurora
District of Columbia
- Washington Hospital Center - Washington D.C.
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2013-11 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What the registry record for NCT02008656 still lists
NCT02008656 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, below the 3,162-participant average among 70 other Rectal Cancer trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT02008656 names 20 study sites across 10 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT02008656 about?
NCT02008656 is a clinical study titled "Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management". The study is designed to test the hypothesis that patients with Locally advanced rectal cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival (DFS) compared to patients with...
What is the current status of trial NCT02008656?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 358 participants. The study started on 2013-11. Estimated completion is 2026-11.
What conditions does trial NCT02008656 study?
This clinical trial studies the following conditions: Rectal Cancer.
What interventions are being tested in trial NCT02008656?
The interventions under investigation include: Leucovorin (DRUG), 5-Fluorouracil (5-FU) (DRUG), Oxaliplatin (OXAL) (DRUG), Capecitabine (Xeloda®) (DRUG), intensity modulated radiotherapy (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT02008656?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02008656 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rectal Cancer
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 NCT02008656's enrollment target sits among peer trials
358 9th of 70 higher than 62 of 70 other Rectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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