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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 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.

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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).

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

FieldValue
Enrollment Target 358 participants
Start Date 2013-11
Est. Completion 2026-11
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

What the Registry Record Tells You About NCT02008656

The ClinicalTrials.gov registry entry for NCT02008656 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,162-participant average among 70 other Rectal Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.