Second-Line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00821990

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 III

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Phase III Clinical Trial of Second-Line Chemotherapy (SLC) in Advanced Gastric Cancer (AGC) Patients Pretreated With Both Fluoropyrimidines and Platinum

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:	January 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: 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.
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 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.

Arms

Assigned Interventions

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: 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.

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

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

Contacts

Contact: Se Hoon Park, MD

82 2 3410 1767

sh1767.park@samsung.com

Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135 710

Sponsors and Collaborators

Samsung Medical Center

More Information

Publications:

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. Review.

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. Review.

Responsible Party:	Samsung Medical Center ( Se Hoon Park, MD )
Study ID Numbers:	SMC IRB 2008-08-055
Study First Received:	December 29, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00821990 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:

Failed after previous chemotherapy

Study placed in the following topic categories:

Docetaxel
Anti-Bacterial Agents
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Irinotecan
Antiemetics
Gastrointestinal Neoplasms
Analgesics
Stomach Cancer

Additional relevant MeSH terms:

Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site

Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009