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Individual patients data based meta-analysis of randomized trials assessing the interest of molecularly targeted treatments of advanced/recurrent stomach cancer: A meta-analysis by the GASTRIC group
Proposal
1816
Title of Proposed Research
Individual patients data based meta-analysis of randomized trials assessing the interest of molecularly targeted treatments of advanced/recurrent stomach cancer:
A meta-analysis by the GASTRIC group
Lead Researcher
Xavier Paoletti
Affiliation
Gustave Roussy Cancer Center
Biostatistics and epidemiology dpt
INSERM CESP U1018 OncoStat
Meta-analysis platform
114 rue Ed Vaillant 94805 Villejuif cedex, France
Funding Source
This work is supported by
- JSPS KAKENHI Grant Number 15617613
- by the French Ministry of health (PHRC)
- as well as by the French Ligue Nationale contre le cancer.
Potential Conflicts of Interest
None
Data Sharing Agreement Date
24 January 2018
Lay Summary
Relapsed stomach cancer is largely an incurable disease. Typical treatments include one or two line of chemotherapy. The only targeted therapy approved in most countries is trastuzumab.
Therefore, finding more efficient agents is a continuous challenge. Multiple agents have been tested in clinical trials. They include several targeted therapies with similar mechanisms of action. Nevertheless, effects of those treatments were mild. It is not unlikely that treatment effect may vary across patients depending on individual characteristics, however this is difficult to assess as it requires large sample sizes.
To explore more precisely the role and action of chemotherapies and targeted agents in the management of stomach cancer, we have initiated a large meta-analysis of all randomized trials testing new agents.
Our objectives are:
- To evaluate the benefit of targeted agents (targeting EGFR or VEGF) relative to chemotherapies or palliative care;
- To evaluate and quantify the variation of treatment effect in terms of patient’s characteristics to identify subgroups that may have a better benefit.
- To investigate whether time to progression is a predictor of the overall survival and whether a treatment that increases the time to progression also increases the overall survival.
This last objective is to find endpoints that would be more rapid to measure than overall survival. Earlier (surrogate) endpoints would make future clinical trials more efficient, more rapid and possibly less expensive.
Study Data Provided
[{ "PostingID": 1362, "Title": "ROCHE-BO18255 (ToGA)", "Description": "An open-label randomized multicentre Phase III study of trastuzumab in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone as first-line therapy in patients with HER2-positive advanced gastric cancer.
Medicine: trastuzumab, Condition: HER2-positive metastatic breast cancer, Phase: 3, Clinical Study ID: BO18255 (ToGA), Sponsor: Roche" },{ "PostingID": 3744, "Title": "LILLY-I4T-IE-JVBD", "Description": "A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy
Medicine: Ramucirumab, Condition: Gastric Cancer, Phase: 3, Clinical Study ID: I4T-IE-JVBD, Sponsor: Lilly" },{ "PostingID": 3745, "Title": "LILLY-I4T-IE-JVBE", "Description": "A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
Medicine: Ramucirumab, Condition: Gastric Cancer, Phase: 3, Clinical Study ID: I4T-IE-JVBE, Sponsor: Lilly" },{ "PostingID": 4758, "Title": "LILLY-I4T-MC-JVBT", "Description": "Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product(IMC-1121B) Versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach
Medicine: Ramucirumab, Condition: Stomach Cancer; Esophageal Cancer, Phase: 2, Clinical Study ID: I4T-MC-JVBT, Sponsor: Lilly" },{ "PostingID": 4801, "Title": "ROCHE-AVF4200G/BO20904", "Description": "(AVAGAST) A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Patients With Advanced Gastric Cancer
Medicine: bevacizumab, Condition: gastric cancer, Phase: 3, Clinical Study ID: AVF4200G/BO20904, Sponsor: Roche" },{ "PostingID": 4802, "Title": "ROCHE-ML22367", "Description": "(AVATAR) A Double-Blind, Randomized, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-Line Therapy in Patients With Advanced Gastric Cancer.
Medicine: bevacizumab, Condition: gastric cancer, Phase: 3, Clinical Study ID: ML22367, Sponsor: Roche" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
The publication citation will be added after the research is published.
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