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

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

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.

Study Overview

• Status: Unknown
• Conditions: Recurrent Colorectal Cancer
• Intervention / Treatment: Combination product: Radiotherapy Combined With Raltitrexed and Irinotecan

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200023
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Irinotecan; Chemoradiotherapy; Raltitrexed; Recurrent Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Folic Acid Antagonists; Irinotecan; Raltitrexed
• Other Study ID Numbers: FDRT-R006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No