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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Capecitabine — DRUG
  Given PO
• 5-fluorouracil — DRUG
  Given IV
• Leucovorin calcium — DRUG
  Given IV
• Irinotecan — DRUG
  Given IV
• Oxaliplatin — DRUG
  Given IV
• Long Course Chemoradiotherapy — RADIATION
  Receive LCRT
• Computed Tomography — PROCEDURE
  undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  undergo MRI
• Sigmoidoscopy — PROCEDURE
  undergo sigmoidoscopy
• biopsy — PROCEDURE
  undergo biopsy

Study Details

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.

Key Dates

Start date

Dec 8, 2022

Status verified

Sep 2025

Primary completion

Sep 30, 2026

Completion

Sep 30, 2033

Study Design

Enrollment

783 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group I (LCRT, FOLFOX or CAPOX)
  Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin IV, fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine PO, and oxaliplatin IV on study. Patients undergo CT scan, MRI, and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.
• Experimental: Group II (LCRT, FOLFIRINOX)
  Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.

Primary Outcome Measure

Clincal Complete Response (cCR) Rates [ Time Frame: Up to 5 years ]

Locations (679)

Find similar trials in Birmingham, AL

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