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Comparison of efficacy and tolerance between combination therapy and monotherapy as first-line chemotherapy in elderly patients with advanced gastric cancer: Study protocol for a randomized controlled trial.

Keun-Wook Lee | Dae Young Zang | Min-Hee Ryu | Ki Hyang Kim | Mi-Jung Kim | Hye Sook Han | Sung Ae Koh | Jin Hyun Park | Jin Won Kim | Byung-Ho Nam | In Sil Choi
Contemporary clinical trials communications | 2017

The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy.

Pubmed ID: 29696197

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ClinicalTrials.gov (tool)

RRID:SCR_002309

Registry and results database of federally and privately supported clinical trials conducted in United States and around world. Provides information about purpose of trial, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.Offers information for locating federally and privately supported clinical trials for wide range of diseases and conditions. Research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. ClinicalTrials.gov contains trials sponsored by National Institutes of Health, other federal agencies, and private industry. Studies listed in database are conducted in all 50 States and in 178 countries.

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EORTC (tool)

RRID:SCR_004070

An independent pan-European clinical research organization to improve the standards of cancer care through the multidisciplinary multinational efforts of basic scientists and clinicians. The efforts include the testing of more effective therapeutic strategies based on drugs, surgery and/or radiotherapy that are already in use. They also contribute to the development of new drugs and other approaches in partnership with the pharmaceutical industry which is accomplished mainly by conducting large, multicenter, prospective, randomized, phase III clinical trials. The EORTC Network comprises over 300 hospitals and cancer centers in over 30 countries which include some 2,500 collaborators from all disciplines involved in cancer treatment and research. The EORTC Headquarters staff handle some 6,000 new patients enrolled each year in cancer clinical trials, approximately 30 protocols that are permanently open to patient entry, over 50,000 patients who are in follow-up, and a database of more than 180,000 patients. Intergroup collaboration is also promoted to face current challenges of clinical trials aiming at targeted therapies in order to recruit a large number of patients within a reasonable period of time.

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