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
Public ClinicalTrials.gov record NCT02008656. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Multicenter Randomized 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02008656
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 358 participants
Conditions and interventions
Conditions
Interventions
- Oxaliplatin (OXAL) Drug
- 5-Fluorouracil (5-FU) Drug
- Leucovorin Drug
- Capecitabine (Xeloda®) Drug
- intensity modulated radiotherapy (IMRT) Radiation
- Quality of Life Questionnaires Behavioral
- DRE-Endoscopy Procedure
Drug · Radiation · Behavioral + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2013 (Actual)
- Primary completion
- Nov 2026 (Estimated)
- Completion
- Nov 2026 (Estimated)
- Last update posted
- Aug 24, 2026
2013 – 2026
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | — |
| St. Joseph Hospital | Orange | California | 92868-3849 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| John Muir Health | Walnut Creek | California | 94598 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| University Of South Florida | Tampa | Florida | 33620 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Michigan | Northville | Michigan | 48168 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| CHI Heath Bergan Mercy | Omaha | Nebraska | 68114 | — |
| Colon and Rectal Surgery, Incorporated | Omaha | Nebraska | 68114 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Memorial Sloan Kettering Cancer Center at Phelps | Sleepy Hollow | New York | 10591 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| University of Washington School of Medicine | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02008656, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02008656 live on ClinicalTrials.gov.