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

NCT ID: NCT00821990

Last Updated: 2012-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-06-30

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.

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.

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: 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

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Best supportive care

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility 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

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samsung Medical Center

Principal Investigators

Se Hoon Park, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Seoul, Korea

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 16782930 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15830569 (View on PubMed)

Other Identifiers

2008-08-055

Identifier Type: -

Identifier Source: org_study_id