Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

NCT03814759 | Completed Phase 2

• 1 other identifier: 4-2015-0603
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 \~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• pathological response rate

  to evaluate pathological response rate in locally advanced resectable gastric cancer

  10 week

Study Arms (1)

SP+CCRT

EXPERIMENTAL

S-1 20mg/m2, bid (D1\~14, D22\~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks

Drug: TS-1 + cisplatin; Radiation: radiation

Interventions

TS-1 + cisplatin DRUG

S-1 20mg/m2, bid (D1\~14, D22\~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)

SP+CCRT

radiation RADIATION

radiation 45Gy per 5 weeks

SP+CCRT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years old
• Histologically confirmed gastric adenocarcinoma
• clinical stage : resectable gastric cancer
• advanced confirmed (EGD)
• extramural infiltration\> 1 mm (CT)
• positive serosa invasion (EUS)
• Eastern Cooperative Oncology Group performance status 0 or 1
• no prior chemotherapy and radiotherapy
• measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
• Patients with adequate organ function
• Signed informed consent

You may not qualify if:

• Metastasis esophageal invasion \> 3cm
• inoperable peritoneal seeding disease determined by exploratory laparotomy
• T4b invading the surrounding organs
• lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node
• uncontrolled viral infections (HIV, HBV, HCV)
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• severe hypersensitivity reactions to S-1, cisplatin
• Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication
• Other co-existing malignancies or malignancies diagnosed within the last 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

titanium silicide; Cisplatin; Radiation

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 24, 2019
• Study Start: December 12, 2016
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2022
• Last Updated: December 27, 2024

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)