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

Summary

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

Interventions

DRUG

Capecitabine

Given PO

DRUG

5-fluorouracil

Given IV

DRUG

Leucovorin calcium

Given IV

DRUG

Irinotecan

Given IV

DRUG

Oxaliplatin

Given IV

RADIATION

Long Course Chemoradiotherapy

Receive LCRT

PROCEDURE

Computed Tomography

undergo CT

PROCEDURE

Magnetic Resonance Imaging

undergo MRI

PROCEDURE

Sigmoidoscopy

undergo sigmoidoscopy

PROCEDURE

biopsy

undergo biopsy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• J. Joshua Smith, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-08

Primary Completion

2026-09-30

Completion

2033-09-30

Countries

• United States
• Puerto Rico

Study Locations