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Completed

NCT Number: NCT03067792

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

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.

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Key information

Conditions

Inoperable Gastric Cancer

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. response rate

    Time frame: up to 2 year

    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.

Secondary outcomes

  1. diseases control rate

    Time frame: up to 2 year

    disease control, defined as the proportion of patients who had a best response of complete response, partial response, or stable

  2. Overall survival

    Time frame: up to 2 year

    overall survival, defined as time from randomisation to death

  3. progression free survival

    Time frame: up to 2 year

    progression-free survival, defined as time from randomisation to radiographic progression or death

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2017
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.