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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821990
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 20, 2012
Sponsor:
Information provided by:
Samsung Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: Chemotherapy Other: Best supportive care Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year after last patient entered ]

Eligibility Criteria
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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821990


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

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Responsible Party: Se Hoon Park, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00821990    
Other Study ID Numbers: 2008-08-055
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012
Keywords provided by Samsung Medical Center:
Failed after previous chemotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases