ILF With/Without Cisplatin for Advanced Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Second-Line Irinotecan vs. ILF for AGC

NCT00509964

Stomach Neoplasm Metastatic Second-Line

UNKNOWN PHASE2

Paclitaxel and Irinotecan in Advanced Gastric Cancer

NCT01136031

Advanced Gastric Cancer

COMPLETED PHASE1/PHASE2

S-1, Cisplatin-based Chemoradiotherapy, Induction Chemotherapy, Locally Advanced Gastric Adenocarcinoma

NCT02495493

Gastric Adenocarcinoma

COMPLETED PHASE2

S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer

NCT01671449

Gastric Cancer

COMPLETED PHASE3

Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer

NCT01444521

Gastric Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen \[Pozzo C, et al. Ann Oncol 2004\]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

irinotecan

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically proven gastric adenocarcinoma
* Advanced, metastatic or recurrent
* ECOG performance status 0 to 2
* No prior chemotherapy
* Measurable or evaluable indicator lesion(s)
* Normal marrow, hepatic and renal functions
* Provision of written informed consent