Evidence map›Paper›PMID 29696197›Full record

ArticleContemporary clinical trials communications2017

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 and 1 more

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Dae Young ZangDepartment of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, South Korea.
Min-Hee RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Ki Hyang KimDepartment of Internal Medicine, Inje University Busan Paik Hospital, Busan, South Korea.
Mi-Jung KimCenter for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Hye Sook HanDepartment of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, South Korea.
Sung Ae KohDepartment of Internal Medicine, Yeungnam University Medical Center, Daegu, South Korea.
Jin Hyun ParkDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.
Jin Won KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Byung-Ho NamDepartment of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, South Korea.
In Sil ChoiDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

methodsThis study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety. DISCUSSION: We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.

Indexed as

5-FU, 5-fluorouracilADL, activities of daily livingAGC, advanced gastric cancerAST/ALT, aspartate aminotransferase/alanine aminotransferaseCCr, creatinine clearanceCGA, comprehensive geriatric assessmentChemotherapyCI, confidence intervalCRF, case report formCT, computed tomographyDSMB, data safety monitoring boardECOG, Eastern Cooperative Oncology GroupElderlyEORTC QLQ-C30, European Organization for Research and Treatment of Cancer core quality of life questionnaireEORTC QLQ-STO22, European Organization for Research and Treatment of Cancer quality of life questionnaire-gastricFAS, full analysis setGastric cancerHER-2, human epidermal growth factor receptor-2HR, hazard ratioIADL, independent activities of daily livingIIT, intent to treatKCSG, Korean Cancer Study GroupKG-7, Korean Cancer Study Group geriatric toolKPS, Karnofsky performance statusNCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse EventsOS, overall survivalPFS, progression-free survivalPPS, per-protocol setPS, performance statusQoL, quality of lifeRandomized controlled trialRCT, randomized controlled trialRECIST, Response Evaluation Criteria in Solid TumorsRR, response rateSAE, serious adverse eventSEER, Surveillance, Epidemiology, and End ResultsUNL, upper normal limit

Identifiers

PMID29696197
PMCPMC5898575

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.