NCT00821990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

December 29, 2008

Last Update Submit

January 18, 2012

Conditions

Advanced Gastric Cancer

Keywords

Failed after previous chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Survival

    1 year after last patient entered

Study Arms (2)

Chemotherapy

ACTIVE COMPARATOR

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: ChemotherapyOther: Best supportive care

Supportive care

ACTIVE COMPARATOR

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

Interventions

ChemotherapyDRUG

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

Chemotherapy
Best supportive careOTHER

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.

ChemotherapySupportive care

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135 710, South Korea

Location

Related Publications (2)

  • Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.

    PMID: 16782930BACKGROUND

  • Wilson D, Hiller L, Geh JI. Review of second-line chemotherapy for advanced gastric adenocarcinoma. Clin Oncol (R Coll Radiol). 2005 Apr;17(2):81-90. doi: 10.1016/j.clon.2004.10.006.

    PMID: 15830569BACKGROUND

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Se Hoon Park, MD

    Samsung Medical Center, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2008

First Posted

January 14, 2009

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

June 1, 2011

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

KR(1)