Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making
NCT ID: NCT03413514
Last Updated: 2018-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-01-03
2023-01-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Compare Different Response Evaluations to Neoadjuvant Chemotherapy for Gastric Cancer
NCT02179463
A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma
NCT02301481
Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy
NCT06277453
Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction
NCT05918419
A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.
NCT02648841
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
experiment group
Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.
NACT
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0\<n\<8)
SDM
Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making
Surgery
Radical surgery with D2 lymph node dissection
ACT
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0\<n\<8)
Questionnaire
MAPPIN'SDM questionnaire, the control performance card, the care questionnaire, the decisional conflict questionnaire, the decisional regret questionnaire, the questionnaire of the reason for stopping neoadjuvant chemotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NACT
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0\<n\<8)
SDM
Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making
Surgery
Radical surgery with D2 lymph node dissection
ACT
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0\<n\<8)
Questionnaire
MAPPIN'SDM questionnaire, the control performance card, the care questionnaire, the decisional conflict questionnaire, the decisional regret questionnaire, the questionnaire of the reason for stopping neoadjuvant chemotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and MRI and laparoscopy.
3. Receive neoadjuvant chemotherapy in clinical
Exclusion Criteria
2. Contraindication for surgery
3. Clinically apparent distant metastasis
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ziyu Li
Chief Physician, Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ziyu Li, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Jiafu Ji, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
Yoshikawa T, Tanabe K, Nishikawa K, Ito Y, Matsui T, Kimura Y, Hirabayashi N, Mikata S, Iwahashi M, Fukushima R, Takiguchi N, Miyashiro I, Morita S, Miyashita Y, Tsuburaya A, Sakamoto J. Induction of a pathological complete response by four courses of neoadjuvant chemotherapy for gastric cancer: early results of the randomized phase II COMPASS trial. Ann Surg Oncol. 2014 Jan;21(1):213-9. doi: 10.1245/s10434-013-3055-x. Epub 2013 Jul 10.
Aoyama T, Nishikawa K, Fujitani K, Tanabe K, Ito S, Matsui T, Miki A, Nemoto H, Sakamaki K, Fukunaga T, Kimura Y, Hirabayashi N, Yoshikawa T. Early results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for locally advanced gastric cancer. Ann Oncol. 2017 Aug 1;28(8):1876-1881. doi: 10.1093/annonc/mdx236.
Schulz C, Kullmann F, Kunzmann V, Fuchs M, Geissler M, Vehling-Kaiser U, Stauder H, Wein A, Al-Batran SE, Kubin T, Schafer C, Stintzing S, Giessen C, Modest DP, Ridwelski K, Heinemann V. NeoFLOT: Multicenter phase II study of perioperative chemotherapy in resectable adenocarcinoma of the gastroesophageal junction or gastric adenocarcinoma-Very good response predominantly in patients with intestinal type tumors. Int J Cancer. 2015 Aug 1;137(3):678-85. doi: 10.1002/ijc.29403. Epub 2015 Feb 25.
Kane HL, Halpern MT, Squiers LB, Treiman KA, McCormack LA. Implementing and evaluating shared decision making in oncology practice. CA Cancer J Clin. 2014 Nov-Dec;64(6):377-88. doi: 10.3322/caac.21245. Epub 2014 Sep 8.
Fried TR. Shared Decision Making--Finding the Sweet Spot. N Engl J Med. 2016 Jan 14;374(2):104-6. doi: 10.1056/NEJMp1510020. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017YJZ51
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.