Clinical trial NCT00821990: Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Gastric Cancer
Keywords: Failed after previous chemotherapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 200
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival
timeFrame: 1 year after last patient entered
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.