Status:
UNKNOWN
A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Recurrent Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04499586
Start Date
January 1 2019
End Date
December 1 2020
Last Update
August 5 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200023