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Completed

NCT Number: NCT00821990

Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer

Because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do not accord with their preferences may influence trial validity, the investigators employed a patient preference randomized trial design to compare the efficacy of second-line chemotherapy and best supportive care.

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Key information

Conditions

Advanced Gastric Cancer

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135 710, South Korea

About this study

Fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in AGC patients because it has shown superiority in terms of response rate and time to disease progression compared with 5-FU monotherapy and other combinations in phase III trials. Despite the lack of evidence for benefit associated with administering salvage chemotherapy, it is a common practice to offer further chemotherapy for AGC patients after first-line failure. For patients who failed after fluoropyrimidine and platinum, taxanes (paclitaxel or docetaxel) and irinotecan have been evaluated extensively in the second-line setting.

Currently, there is no evidence that SLC in patients with AGC will result in substantial prolongation of survival and there is potential for toxicity from the treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged 75 year or younger
  • advanced gastric cancer
  • ECOG performance status 0 or 1
  • previous failure after chemotherapy with fluoropyrimidine and platinum
  • adequate major organ functions

Exclusion criteria

  • severe concurrent illness and/or active infection
  • previously treated with taxanes and irinotecan
  • active CNS metastases
  • pregnant or lactating women
  • who have not recovered from prior treatments

Treatment and study plan

Chemotherapy

Drug

The administration of chemotherapy regimen (docetaxel or irinotecan) will be determined at the discretion of investigator, and depends on the patient's previous chemotherapy.

Best supportive care

Other

It includes nutritional support, analgesics, antibiotics, antiemetics, transfusions, or any other symptomatic therapy (with the exception of cytotoxic chemotherapy) and/or assistance of a psychological support. Localized radiotherapy to alleviate symptoms such as pain is allowed provided that the total dose delivered is in a palliative range.

Primary outcomes

  1. Survival

    Time frame: 1 year after last patient entered

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

A Patient Preference Randomized Phase III Clinical Trial of Second-line Chemotherapy (SLC) in Advanced Gastric Cancer (AGC) Patients Pretreated With Both Fluoropyrimidines and Platinum

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jan 14, 2009
Registry last updated
Jan 20, 2012

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.

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