Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

Description

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

Conditions

Locally Advanced Rectal Carcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

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Study Overview

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Study Details

Study overview

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

Condition
Locally Advanced Rectal Carcinoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States, 35233

Mobile

University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States, 36688

Anchorage

Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States, 98508

Anchorage

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States, 99508

Anchorage

Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States, 99508

Anchorage

Alaska Women's Cancer Care, Anchorage, Alaska, United States, 99508

Anchorage

Anchorage Oncology Centre, Anchorage, Alaska, United States, 99508

Anchorage

Katmai Oncology Group, Anchorage, Alaska, United States, 99508

Anchorage

Providence Alaska Medical Center, Anchorage, Alaska, United States, 99508

Kingman

Kingman Regional Medical Center, Kingman, Arizona, United States, 86401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
  • * Tumor site: Rectum; =\< 12cm from the anal verge
  • * No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed
  • * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
  • * Age \>= 18 years
  • * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
  • * Absolute neutrophil count (ANC) \>= 1,500/mm\^3
  • * Platelet count \>= 100,000/mm
  • * Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min
  • * Total bilirubin =\< 1.5 x upper limit of normal (ULN)
  • * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
  • * No upper rectal tumors (distal margin of tumor \> 12 cm from the anal verge)
  • * No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
  • * No known mismatch repair deficient rectal adenocarcinoma
  • * Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
  • * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
  • * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study \* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alliance for Clinical Trials in Oncology,

J. Joshua Smith, MD, STUDY_CHAIR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2032-09