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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00821990
First received: December 29, 2008
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced Gastric Cancer
 Drug: Chemotherapy
Other: Best supportive care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Survival [ Time Frame: 1 year after last patient entered ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy
Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care).
 Drug: Chemotherapy
The administration of chemotherapy regimen (docetaxel or irinotecan) will be determined at the discretion of investigator, and depends on the patient's previous chemotherapy.
Other: Best supportive care
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.
Active Comparator: Supportive care
Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care).
 Other: Best supportive care
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821990

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135 710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Se Hoon Park, MD Samsung Medical Center, Seoul, Korea
  More Information

Publications:

Responsible Party: Se Hoon Park, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00821990     History of Changes
Other Study ID Numbers: 2008-08-055
Study First Received: December 29, 2008
Last Updated: January 18, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Failed after previous chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 19, 2013