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

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 2 Interventional 18 Years and older Memorial Sloan Kettering Cancer Center 13-213
NCT02008656
Enrolling patients

Study Design:


Principal Investigator

Professor of Surgery
Division of General Surgery
Chief, Section of Colorectal Surgery 
Maurice Galante, MD Distinguished Professor in Surgical Oncology
Director, UCSF Center for Pelvic Physiology 

Jessica Rhee
Jessica.rhee@ucsfmedctr.org 


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).

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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
X