Clinical trial NCT03413514: Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making
Official title: A Non-Randomized,Single Center Study to Investigate the Real World Evidence for the Maximal Cycle of Effective Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: shared decision making
neoadjuvant chemotherapy
cycle
MRI
clinical response
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer, to determine what is the best cycle of neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy.

Detailed description: The study is a non-randomized clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. MRI and enhanced CT are used to evaluate the clinical response of the tumor. The primary endpoint is the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer.

Eligibility criteria: Inclusion Criteria:

1. Histologically proven adenocarcinoma of the stomach
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:

1. Contraindication for chemotherapy
2. Contraindication for surgery
3. Clinically apparent distant metastasis

Primary outcomes:
measure: The cycle of neoadjuvant chemotherapy
timeFrame: 18months
Secondary outcomes:
measure: The clinical response rate
timeFrame: 18 months
measure: The completion rate of perioperative chemotherapy
timeFrame: 18 months
measure: The progressive disease rate
timeFrame: 18 months
measure: The pathological response
timeFrame: 18 months
measure: The pathological complete response
timeFrame: 18months
measure: The adverse event of chemotherapy
timeFrame: 18 months
measure: Surgical morbidity
timeFrame: 18 months
measure: The 3-year progression-free survival
timeFrame: 48months
measure: The cTNM,ycTNM,ypTNM stage
timeFrame: 60months
measure: The decisional conflicts
timeFrame: 12months
measure: The decisional regrets
timeFrame: 12months
measure: The involvement of patients during the shared decision making
timeFrame: 12months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ziyu Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Jiafu Ji, MD,PHD
role: PRINCIPAL_INVESTIGATOR
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