Clinical trial NCT04499586: A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer
Official title: A Phase II Trial of Radiotherapy Combined With Raltitrexed and Irinotecan(CPT-11) in Patients With Metastatic or Locally Recurrent Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Colorectal Cancer
Keywords: Recurrent Colorectal Cancer
Irinotecan
Raltitrexed
Chemoradiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)
timeFrame: 20 weeks
Secondary outcomes:
measure: DCR(Disease Control Rate)
timeFrame: 20 weeks
measure: PFS(Progression Free Survival)
timeFrame: 24 months
measure: the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: