Clinical trial NCT04416854: The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
Official title: The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Colon Cancer
Surgery
Keywords: palliative surgery
stage IV colon cancer
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.


Eligibility criteria: Inclusion Criteria:

* 75 years old
* ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
* Pathological diagnosis of colon cancer adenocarcinoma
* At least one measurable objective tumor lesions which could be evaluated.
* Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
* ANC≥1.5\*109/L；PLT≥90\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
* No systemic chemotherapy
* Patients with voluntary participation, and sign the informed consent

Exclusion Criteria:

* Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
* Multiple primary colorectal carcinoma
* Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
* Uncontrolled pleural effusion
* Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
* With brain metastasis or meningeal metastasis
* Pregnancy or breast-feeding women
* Alcohol or drug addictions
* There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation

Primary outcomes:
measure: Overall survival
timeFrame: 5-year
Secondary outcomes:
measure: Progression-free survival 1
timeFrame: 3-year
measure: Progression-free survival 2
timeFrame: 3-year
measure: The rate of adverse events resulted from chemotherapy
timeFrame: 3-year
measure: The quality of life postoperatively
timeFrame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
measure: Objective response rate
timeFrame: 1-year
measure: The rate of postoperative complications
timeFrame: 1-year
measure: The proportion of surgical intervention in control group
timeFrame: 1-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: