Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI

NCT03504618 | Completed

• 1 other identifier: HMU16223
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (10)

• Patients' characteristic

  Clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable

  4 years

• Response rate after 3 cycles

  Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.

  At the end of Cycle 3 (each cycle is 4 weeks)

• Response rate after 6 cycles

  Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.

  At the end of Cycle 6 (each cycle is 4 weeks)

• Correlation between response rate and percentage of chemotherapy dosage

  Prognostic factor of response rate

  4 years

• Correlation between response rate and histopathology

  Prognostic factor of response rate

  4 year

• Correlation between response rate and metastatic site

  The average size of the hepatic metastatic lesion in the study

  4 years

• Prognostic factor for response rate after 3 cycles

  Evaluation of predictor of response rate

  At the end of cycle 3 (each cycle is 4 weeks)

• Prognostic factor for response rate after 6 cycles

  Evaluation of predictor of response rate

  At the end of cycle 6 (each cycle is 4 weeks)

• Mean of the progression free survival

  The median progression free survival of the study population

  4 years

• Prognostic factor of progression free survival

  Evaluation of predictor of progression free survival

  4 years

Secondary Outcomes (3)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  4 years

• Overall survival after 12 months

  12 months after the last patient finish chemotherapy

• Overall survival after 24 months

  24 months after the last patient finish chemotherapy

Study Arms (1)

Metastatic colon cancer patients

Colon cancer patients with metastase at the diagnostic time, impossibility of radical resection, adenocarcinoma, treated by at least 3 cycles of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department

Drug: FOLFOXIRI

Interventions

FOLFOXIRI DRUG

Treatment of FOLFOXIRI regimen at first line with dosage: Irinotecan: 165 mg / m2, intravenous infusion for 1 hour. Day 1, 15. Oxaliplatin: 85 mg / m2, intravenously for 2 hours Day 1, 15 Calcium folinate 200 mg / m2, intravenously for 2 hours Day 1, 15 5FU 3200 mg / m 2, intravenous infusion continuously for 48 hours Day 1, 2, 3, 15, 16, 17 Every 4 weeks. Each cycle has 2 infusion times, the first one is the first day, the second one is the 15th day

Metastatic colon cancer patients

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University

Hanoi, 10000, Vietnam

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

FOLFOXIRI protocol

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Science Research and International Cooperation Unit

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 20, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 1, 2018
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

VN (1)