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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial of Radiotherapy Combined With Raltitrexed and Irinotecan(CPT-11) in Patients With Metastatic or Locally Recurrent Colorectal Cancer

Conditions
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Recurrent Colorectal Cancer

Intervention / Treatment
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* Combination Product: Radiotherapy Combined With Raltitrexed and Irinotecan


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy Combined With Raltitrexed and Irinotecan<br>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 | Combination Product: Radiotherapy Combined With Raltitrexed and Irinotecan<br>* Each cycle lasts 3 weeks. Raltitrexed: 3mg/m2 per week. Irinotecan : 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) per week. Radiation: 45-55Gy/25-30Fx<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate) |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCR(Disease Control Rate) |  | 20 weeks | 
| PFS(Progression Free Survival) |  | 24 months | 
| the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 |  | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Colorectal Cancer, Irinotecan, Raltitrexed, Chemoradiotherapy