Clinical trial NCT03504618: Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI
Official title: Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI Regimen (Folinic Acid, 5-fluorouracil, Oxaliplatin and Irinotecan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recruited to the study will be explained in detail will be required to sign a volunteer card. All detailed information on the patient's medical condition is encrypted and confidential. The patient has the right to withdraw from the study

Brief summary: Colon cancer with metastase in the diagnose time account for one significant rate and has a increasing trend. The treatment result of this patient group rests modest. The biological therapeutic treatment is still expensive for major part of Vietnamese patients. So that, research on a new affordable and efficacious chemotherapy combination for these patients is extremely necessary in our country The purpose of the study is to comment somes clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable.

The second aim is to Evaluate the treatment result and toxicity of FOLFOXIRI in these patients

Detailed description: In the world, colorectal cancer is the third most common cancer in male and the second most common cancer in female. In VietNam, the disease is the fourth cancer in male, the sixth cancer in female and increasing recently. About 20-40% of the colon cancer patients had distant metastasis at the time of diagnose, those treatment outcome remains poor (5years survival is about 11%). The targetted therapy medications are still not affordable for majority of Vietnamese patients. So that, 3 cytotoxic drugs (5-Fluoro-Uracil, Oxaliplatin and Irinotecan) remain back-bone in the treatment of metastatic colon cancer.

According to one meta-analysis, the overall survival rate significantly correlated to the use of all 3 these drugs in the treatment time. If patients were give two drugs as the doublet in a line (FOLFOX/XELOX, FOLFIRI/XELIRI), not 100% of patients are treated with all 3 these drugs because some abandonned the following treatment lines. So, the trials that give all 3 drugs in a line (first-line) as triplet (FOLFOXIRI) were carried out and had primirily good outcome. In 2010, FOLFOXIRI were recommended in NCCN guideline.

In VietNam, FOLFOXIRI has been applied to treat patient since 2013. However, since then there was no clinical trial to evaluate the efficacy and the toxicity of this combination. Therefore, we carried out the work "Research on the treatment of metastatic colon cancer patients treated by FOLFOXIRI"

Eligibility criteria: Inclusion Criteria:

* 39 colon cancer patients with metastase at the diagnotic time, impossiblity of radical resection, adenocarcinoma, treated by at least 3 cylces of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department, Ha Noi medical university hospital, from September 2013 to April 2017

Primary outcomes:
measure: Patients' characteristic
timeFrame: 4 years
measure: Response rate after 3 cycles
timeFrame: At the end of Cycle 3 (each cycle is 4 weeks)
measure: Response rate after 6 cycles
timeFrame: At the end of Cycle 6 (each cycle is 4 weeks)
measure: Correlation between response rate and percentage of chemotherapy dosage
timeFrame: 4 years
measure: Correlation between response rate and histopathology
timeFrame: 4 year
measure: Correlation between response rate and metastatic site
timeFrame: 4 years
measure: Prognostic factor for response rate after 3 cycles
timeFrame: At the end of cycle 3 (each cycle is 4 weeks)
measure: Prognostic factor for response rate after 6 cycles
timeFrame: At the end of cycle 6 (each cycle is 4 weeks)
measure: Mean of the progression free survival
timeFrame: 4 years
measure: Prognostic factor of progression free survival
timeFrame: 4 years
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 4 years
measure: Overall survival after 12 months
timeFrame: 12 months after the last patient finish chemotherapy
measure: Overall survival after 24 months
timeFrame: 24 months after the last patient finish chemotherapy
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
References: