Clinical trial · Interventional
Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive care | Other | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- 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).
- interventionNames
- Drug: Chemotherapy
- Other: Best supportive care
- type
- ACTIVE_COMPARATOR
- label
- Supportive care
- description
- 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).
- interventionNames
- Other: Best supportive care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDWagner 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 16782930
- BACKGROUNDWilson 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 15830569