FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer

NCT03067792 | Completed Phase 3

• 1 other identifier: 4-2014-0626
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy. Palliative chemotherapy had proven to be better overall survivals and quality of life in unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic regimen as a first line therapy. But response rate of those regimens is about 50 percent. Disappointingly most of cases are about to experience progression of disease. Second line regimens of palliative chemotherapy are also have shown its efficacy and recommended within patients with better performance status. But There is still lack of evidences in gastric cancer patients second line chemotherapy. Several phase II trial those subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in combination with paclitaxel would increase response rate in patient previously treated for advanced gastric cancer compared with FOFIRI regimen.

Conditions

Inoperable Gastric Cancer

Keywords

inoperable gastric cancer; palliative chemotherapy

Outcome Measures

Primary Outcomes (1)

• response rate

  CT examination would be done at 7\~8 weeks after initiation of 1st cycle chemotherapeutic agent, After 2 cycle of chemotherapy in DP group and 3cyle of chemotherapy in FOFIRI group.

  up to 2 year

Secondary Outcomes (3)

• diseases control rate

  up to 2 year

• Overall survival

  up to 2 year

• progression free survival

  up to 2 year

Study Arms (2)

FOLFIRI

ACTIVE COMPARATOR

2nd palliative chemotherapy with FOLFIRI regimen,In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5- fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle. Response evaluation would be done after 3 cycle of chemotherapy in DP group

Drug: 5-fluorouracil, irinotecan and leucovorin

DP

ACTIVE COMPARATOR

2nd palliative chemotherapy with Docetaxel/cisplatin regimen, In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle. Response evaluation would be done after 2 cycle of chemotherapy in DP group

Drug: docetaxel and cisplatin

Interventions

5-fluorouracil, irinotecan and leucovorin DRUG

In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5-fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle.

FOLFIRI

docetaxel and cisplatin DRUG

In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.

DP

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 19 years old and younger than 75 years old
• Pathologically confirmed gastric cancer
• Inoperable stage at diagnosis
• experienced diseases progression in first line palliative chemotherapy
• ECOG performance status 0 or 1
• Adequate renal function (serum creatinine \< 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
• Adequate liver function (total bilirubin \< 1.5 X the upper limits of normal (ULN), AST and ALT \<3 X UNL, and alkaline phosphatases \< 3 X ULN or \< 5 x ULN in case of liver involvement)
• Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
• Subjects who given written informed consent after being given a full description of the study

You may not qualify if:

• double primary cancer other than gastric cancer
• history of palliative radiation therapy
• Pregnant or on breast feeding
• Neuropathy grade \> 3
• Active infection
• Symptomatic cardiopulmonary diseases
• Active hepatitis of liver cirrhosis
• Impaired renal function
• Impaired psychologic bone marrow function
• Psychologic disorder, Severe neurologic disorder.
• hypersensitivity to chemotherapeutic agent

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Interventions

Fluorouracil; Irinotecan; Leucovorin; Docetaxel; Cisplatin

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 1, 2017
• Study Start: December 1, 2014
• Primary Completion: October 17, 2016
• Study Completion: October 17, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share