Neoplasms Clinical Trial
Official title:
Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases Versus Chemotherapy Alone
NCT number | NCT05322486 |
Other study ID # | 22A/20 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 29, 2020 |
Est. completion date | December 2022 |
Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed colorectal adenocarcinoma 2. Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis 3. Age = 18 years 4. Informed consent Exclusion Criteria: 1. Synchronous cancers 2. Carcinomatosis 3. Prior surgery, chemotherapy, radiation therapy for the primary tumor or distant metastases |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Ryzhikh National Medical Research Center of Coloproctology | Moscow |
Lead Sponsor | Collaborator |
---|---|
State Scientific Centre of Coloproctology, Russian Federation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | 3 years | ||
Secondary | Thirty-day mortality | 30 days | ||
Secondary | Rate of surgical intervention due to complication of treatment | 1 year | ||
Secondary | Progression free survival (PFS) | PFS is defined as the time interval between the date of diagnosis and the first date of progression of the metastatic disease or death in both treatment arms. | 3 years |
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