A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer

Phase 2

• Conditions: Recurrent Colorectal Cancer
• Interventions: Combination Product: Radiotherapy Combined With Raltitrexed and Irinotecan

• Registration Number: NCT04499586
• Lead Sponsor: Fudan University

Brief Summary

The study evaluates the effectiveness of radiotherapy combined with raltitrexed and irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer that has not responded to fluorouracil. The patients will receive radiotherapy combined with raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Last Update Submitted: 2020-07-31
• Primary Completion: 2020-08-01
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Histologically proven metastatic, advanced, or locally recurrent fluorouracil (5-FU) and oxaliplatin refractory adenocarcinoma of the colon or rectum; Progression of disease within 6 months of receiving adjuvant 5-FU and oxaliplatin chemotherapy OR Progression of disease during or following completion of 5-FU and oxaliplatin chemotherapy for metastatic disease
• Evaluable lesions with indications of radiotherapy
• No other metastatic lesions in the radiation field
• Karnofsky Performance Status>=70
• UGT1A1*28 6/6 or 6/7
• Subject blood routine and biochemical indicators meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
• Able to follow the protocol during the study period
• Sign the inform consent

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Exclusion Criteria

• Pregnant or breastfeeding women
• If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
• Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
• Organ transplantation requires immunosuppressive therapy
• Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
• Anyone who is allergic to any research medication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy Combined With Raltitrexed and Irinotecan	Radiotherapy Combined With Raltitrexed and Irinotecan	Each cycle lasts 3 weeks. Administration of Raltitrexed and Irinotecan weekly followed by a 2 week 'rest' period with no drug given. Raltitrexed is given by IV infusion at a dose of 3mg/m2. Irinotecan is given by IV infusion at a dose of 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7).Radiation: 45-55Gy/25-30Fx

Primary Outcome Measures

Name	Time	Method
ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)	20 weeks

Secondary Outcome Measures

Name	Time	Method
PFS(Progression Free Survival)	24 months
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0	20 weeks
DCR(Disease Control Rate)	20 weeks

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China