# 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

> **NCT05610163** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Alliance for Clinical Trials in Oncology** · enrollment: 783 (actual)

## Conditions studied

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

## Interventions

- **DRUG:** Capecitabine
- **DRUG:** 5-fluorouracil
- **DRUG:** Leucovorin calcium
- **DRUG:** Irinotecan
- **DRUG:** Oxaliplatin
- **RADIATION:** Long Course Chemoradiotherapy
- **PROCEDURE:** Computed Tomography
- **PROCEDURE:** Magnetic Resonance Imaging
- **PROCEDURE:** Sigmoidoscopy
- **PROCEDURE:** biopsy

## Key facts

- **NCT ID:** NCT05610163
- **Lead sponsor:** Alliance for Clinical Trials in Oncology
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-12-08
- **Primary completion:** 2026-09-30
- **Final completion:** 2033-09-30
- **Target enrollment:** 783 (ACTUAL)
- **Last updated:** 2025-09-08

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05610163

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05610163, "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". Retrieved via AI Analytics 2026-07-09 from https://api.ai-analytics.org/clinical/NCT05610163. Licensed CC0.

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