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Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

NCT03223740 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2017-08-21

No results posted yet for this study

Summary

Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.

Conditions

  • Locally Advanced Gastric Carcinoma

Interventions

OTHER

Arm 1 pre-operative chemoradiation

Chemotherapy 1: First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition. 2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29.

OTHER

Arm 2 post operative chemoradiation

Surgical resection, a D2 resection is encouraged. Chemotherapy 1: All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: 2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29

Sponsors & Collaborators

  • Xijing Hospital

    collaborator OTHER

  • Sichuan Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Ming Zeng, MD PhD · Sichuan Academy of Medical Science

  • Hongwei Zhang, MD PhD · Xijing Hosptial, GI institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-09-30
Completion
2021-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03223740 on ClinicalTrials.gov