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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02008656
• Other study ID #: 13-213
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 358
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of adenocarcinoma of the rectum

• 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

• No evidence of distant metastases

• No prior pelvic radiation therapy

• No prior chemotherapy or surgery for rectal cancer

• Age = 18 years The minimum legal age of consent for select Canadian provinces is 19

• No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)

• ECOG Performance status 0-2

• Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. A woman of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.

• Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Patients who do not read or understand English are eligible and may be consented according to institutional and federal regulations.

• ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3 total bilirubin = 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin = 3.0 x ULN), AST= 3 x ULN, ALT = 3 x ULN.

Exclusion Criteria:

• Recurrent rectal cancer

• Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en block resection will not achieve negative margins.

• Creatinine level greater than 1.5 times the upper limit of normal.

• Patients who have received prior pelvic radiotherapy.

• Patients who are unable to undergo an MRI.

• Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.

• Patients with a history of venous thrombotic episodes such as deep venous thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.

• Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.

• WOCBP who are unwilling or unable to use an acceptable method of avoiding pregnancy for the entire study period.

• Women who are pregnant or breast-feeding.

• Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.

• Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Oxaliplatin (OXAL)

• 5-Fluorouracil (5-FU)

• Leucovorin

• Capecitabine (Xeloda®)

Radiation:
• intensity modulated radiotherapy (IMRT)

Behavioral:
• Quality of Life Questionnaires

Procedure:
• DRE-Endoscopy

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	University of Vermont Medical Center	Burlington	Vermont
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	University of California, Irvine	Irvine	California
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Michigan	Northville	Michigan
United States	CHI Heath Bergan Mercy	Omaha	Nebraska
United States	Colon and Rectal Surgery, Incorporated	Omaha	Nebraska
United States	St. Joseph Hospital	Orange	California
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California San Francisco	San Francisco	California
United States	University of Washington School of Medicine	Seattle	Washington
United States	Memorial Sloan Kettering Cancer Center at Phelps	Sleepy Hollow	New York
United States	University Of South Florida	Tampa	Florida
United States	Memorial Sloan Kettering Nassau	Uniondale	New York
United States	John Muir Health	Walnut Creek	California
United States	Washington Hospital Center	Washington	District of Columbia
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (23)

Lead Sponsor

Collaborator

Memorial Sloan Kettering Cancer Center

Cleveland Clinic Florida, Colon and Rectal Surgery Inc., Creighton University Medical Center, John Muir Health, Medstar Health Research Institute, Oregon Health and Science University, St. Joseph Hospital of Orange, St. Joseph, Florida, St. Paul's Hospital, The Cleveland Clinic, The Methodist Hospital Research Institute, University of California, Irvine, University of California, San Francisco, University of Chicago, University of Colorado, Denver, University of Michigan, University of Rochester, University of South Florida, University of Vermont, University of Virginia, University of Washington, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival (DFS)	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	3 years
Secondary	major adverse events	Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.	3 years

External Links

•   Memorial Sloan Kettering Cancer Center