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

NCT04499586 | Unknown Phase 2

• 1 other identifier: FDRT-R006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Colorectal Cancer

Keywords

Recurrent Colorectal Cancer; Irinotecan; Raltitrexed; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)

  20 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Radiotherapy Combined With Raltitrexed and Irinotecan

EXPERIMENTAL

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

Interventions

Radiotherapy Combined With Raltitrexed and Irinotecan COMBINATION_PRODUCT

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

Radiotherapy Combined With Raltitrexed and Irinotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200023, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

raltitrexed; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Zhen Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: January 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-07

Locations

CN (1)