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

• ClinicalTrials.gov Identifier: NCT03504618
• Recruitment Status: Completed
• First Posted: April 20, 2018
• Last Update Posted: April 20, 2018
• Sponsor: Hanoi Medical University
• Information provided by (Responsible Party): Bui My Hanh, Hanoi Medical University

Study Description

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

Condition or disease	Intervention/treatment
Colorectal Cancer	Drug: FOLFOXIRI

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"

Study Design

• Study Type: Observational
• Actual Enrollment: 39 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI Regimen (Folinic Acid, 5-fluorouracil, Oxaliplatin and Irinotecan)
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: December 31, 2017
• Actual Study Completion Date: February 1, 2018

Groups and Cohorts

Group/Cohort

Intervention/treatment

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; 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

Outcome Measures

Primary Outcome Measures :

1. Patients' characteristic [ Time Frame: 4 years ]
   Clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable
2. Response rate after 3 cycles [ Time Frame: At the end of Cycle 3 (each cycle is 4 weeks) ]
   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.
3. Response rate after 6 cycles [ Time Frame: At the end of Cycle 6 (each cycle is 4 weeks) ]
   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.
4. Correlation between response rate and percentage of chemotherapy dosage [ Time Frame: 4 years ]
   Prognostic factor of response rate
5. Correlation between response rate and histopathology [ Time Frame: 4 year ]
   Prognostic factor of response rate
6. Correlation between response rate and metastatic site [ Time Frame: 4 years ]
   The average size of the hepatic metastatic lesion in the study
7. Prognostic factor for response rate after 3 cycles [ Time Frame: At the end of cycle 3 (each cycle is 4 weeks) ]
   Evaluation of predictor of response rate
8. Prognostic factor for response rate after 6 cycles [ Time Frame: At the end of cycle 6 (each cycle is 4 weeks) ]
   Evaluation of predictor of response rate
9. Mean of the progression free survival [ Time Frame: 4 years ]
   The median progression free survival of the study population
10. Prognostic factor of progression free survival [ Time Frame: 4 years ]
    Evaluation of predictor of progression free survival

Secondary Outcome Measures :

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 years ]
   During the full length of first-line treatment, number of enrolled patients reporting adverse events is recorded. Adverse events are evaluated according to National Cancer Institute Common Toxicity Criteria latest version.
2. Overall survival after 12 months [ Time Frame: 12 months after the last patient finish chemotherapy ]
   The percentage of survival patients 12 month after finishing treatment with FOLFOXIRI regimen
3. Overall survival after 24 months [ Time Frame: 24 months after the last patient finish chemotherapy ]
   The percentage of survival patients 24 month after finishing treatment with FOLFOXIRI regimen

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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

Contacts and Locations

Locations

Vietnam

Hanoi Medical University

Hanoi, Vietnam, 10000

Sponsors and Collaborators

Hanoi Medical University

More Information

• Responsible Party: Bui My Hanh, Director, Science Research and International Cooperation Unit, Hanoi Medical University
• ClinicalTrials.gov Identifier: NCT03504618
• Other Study ID Numbers: HMU16223
• First Posted: April 20, 2018
• Last Update Posted: April 20, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases