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Chemotherapy

Leucovorin for Colorectal Cancer

Phase 2

Waitlist Available

Led By Julio Garcia Aguilar, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI

Rectal tumor at baseline which would be considered to require complete TME

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will compare two different treatments for locally advanced rectal cancer to see which one results in better 3-year disease-free survival rates.

Who is the study for?

This trial is for adults with locally advanced rectal cancer who haven't had previous treatments like chemotherapy, surgery, or pelvic radiation. They should be generally healthy without active infections and no history of certain cancers in the past 5 years. Women must not be pregnant and agree to use contraception.Check my eligibility

What is being tested?

The study tests if a complete treatment before surgery (TNT) followed by either total mesorectal excision (TME) or non-operative management (NOM) improves disease-free survival over standard chemoradiation therapy plus TME and additional chemotherapy.See study design

What are the potential side effects?

Possible side effects include those from radiotherapy such as skin irritation, fatigue, digestive issues; chemotherapy can cause nausea, low blood counts leading to infection risk, nerve damage from Oxaliplatin; endoscopy may result in discomfort or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is at Stage II or III according to MRI results.

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My rectal cancer needs a total mesorectal excision.

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My diagnosis is rectal adenocarcinoma.

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My cancer has not spread to distant parts of my body.

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I have not had chemotherapy or surgery for rectal cancer.

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I am at least 18 years old, or 19 if living in certain Canadian provinces.

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I can take care of myself and am up and about more than half of my waking hours.

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I have not had radiation therapy to my pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease

Secondary outcome measures

major adverse events

Trial Design

2Treatment groups

Experimental Treatment

Group I: INCTExperimental Treatment7 Interventions

Arm 1 will receive chemotherapy before chemoradiation. This is called induction neoadjuvant chemotherapy arm (INCT). The neoadjuvant chemotherapy regimen is prescribed specifically as 8 cycles of FOLFOX or 5 cycles of CapeOX over a period of approximately 15-16 weeks. Endoscopic exam (2-4 wks) after chemotherapy. If stable or response then pt will have radiation with either 5-FU or capecitabine.

Group II: CNCTExperimental Treatment7 Interventions

Arm 2 will receive chemoradiation before chemotherapy This is called the consolidation neoadjuvant chemotherapy arm (CNCT). Pt will have 6 weeks of chemoradiation therapy. Along with the radiation the pt will receive either 5-FU or capecitabine. 2-4 weeks after pt will have endoscopic exam and if stable or response pt will have will have 8 cycles of FOLFOX or 6 cycles of CapeOX.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin

2005

Completed Phase 4

~5730

Quality of Life Questionnaires

2005

Completed Phase 4

~1380

5-Fluorouracil (5-FU)

2003

Completed Phase 3

~5560

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VermontOTHER

268 Previous Clinical Trials

3,743,387 Total Patients Enrolled

Medstar Health Research InstituteOTHER

189 Previous Clinical Trials

115,215 Total Patients Enrolled

St. Joseph, FloridaUNKNOWN

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02008656 — Phase 2

Colorectal Cancer Research Study Groups: INCT, CNCT

Colorectal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT02008656 — Phase 2

Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02008656 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many medical centers enacting this experiment in the region?

"The University of Washington School of Medicine, CHI Heath Bergan Mercy and the University of Vermont Medical Centre are three such sites for this trial; in total, 30 locations throughout the nation are offering patient enrolment."

Answered by AI

What therapeutic objectives are typically met through intensity modulated radiotherapy (IMRT)?

"Intensity modulated radiotherapy (IMRT) is a highly effective treatment for rectal carcinoma, as well as metastatic colorectal and pancreatic endocrine carcinomas or advanced esophageal cancers."

Answered by AI

Is this research still open for enrolment?

"This research endeavour, which was initially posted on November 1st 2013 and lastly updated on December 1st 2022, is not enrolling individuals at this moment. However, there are thousands of studies actively searching for people to take part in them."

Answered by AI

What have been the outcomes of previous experiments on intensity modulated radiotherapy (IMRT)?

"At the moment, 727 trials that involve intensity modulated radiotherapy (IMRT) are underway. Of those studies, 249 are in Phase 3 of their study process. Major hubs for these trials include Guangzhou and Guangdong with 29828 other locations carrying out IMRT research."

Answered by AI

Has intensity modulated radiotherapy (IMRT) been ratified by the FDA?

"Our team at Power has assigned intensity modulated radiotherapy (IMRT) a safety rating of 2, since there is evidence to back up its security but none that supports efficacy as this is only Phase 2."

Answered by AI

What is the scope of individuals involved in this experiment?

"This experiment is no longer recruiting participants. Originally posted in November 2013 and last modified December 2022, it has since been concluded. If you're looking for other research opportunities, there are currently 340 studies related to rectal cancer and 727 involving intensity modulated radiotherapy (IMRT) actively enrolling volunteers."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Playing with Dynamite? A Cautious Assessment of TNT

Shi, Diana D., and Harvey J. Mamon. 2021. “Playing with Dynamite? A Cautious Assessment of TNT”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.02199.

BMC CancerJournal

Organ Preservation in Rectal Adenocarcinoma: A Phase II Randomized Controlled 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 Nonoperative Management

Smith, J. Joshua, on behalf of the Rectal Cancer Consortium, Oliver S. Chow, Marc J. Gollub, Garrett M. Nash, Larissa K. Temple, Martin R. Weiser, et al.. 2015. “Organ Preservation in Rectal Adenocarcinoma: A Phase II Randomized Controlled 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 Nonoperative Management”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-015-1632-z.

The Lancet OncologyJournal

Effect of Adding Mfolfox6 After Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer: A Multicentre, Phase 2 Trial

Garcia-Aguilar, Julio, Oliver S Chow, David D Smith, Jorge E Marcet, Peter A Cataldo, Madhulika G Varma, Anjali S Kumar, et al.. 2015. “Effect of Adding Mfolfox6 After Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer: A Multicentre, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00004-2.

The Lancet OncologyJournal