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

Recurrent Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04499586
• Other study ID #: FDRT-R006
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Recurrent Colorectal Cancer

Intervention

Combination Product:
• Radiotherapy Combined With Raltitrexed and Irinotecan
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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)		20 weeks
Secondary	DCR(Disease Control Rate)		20 weeks
Secondary	PFS(Progression Free Survival)		24 months
Secondary	the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0		20 weeks