Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

Phase 3

• Conditions: Locally Advanced Gastric Carcinoma
• Interventions: Other: Arm 1 pre-operative chemoradiation; Other: Arm 2 post operative chemoradiation

• Registration Number: NCT03223740
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21
• Primary Completion: 2020-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
• EUS or MRI stage T3-4, any N, M0.
• Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
• Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
• No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
• Patients must have a life expectancy of at least 16 weeks.
• Performance status of < 2 (Zubrod scale).
• No biopsy proof of lymph node metastases outside the study field.
• No evidence of metastatic disease to distant organs.
• No presence of concurrent or previous malignancies < 5 years, other than noninvasive skin cancer.
• No uncontrolled or severe cardiac disease, diabetes or hypertension.
• Signed study-specific consent form prior to study entry.

Exclusion Criteria

• Evidence of metastatic disease
• Prior chemotherapy or radiotherapy
• Patients with a past history of cancer
• Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
• Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
• Cardiac failure or Sever Pulmonary disease
• Patients with impaired gastrointestinal absorption for whatever reason
• Patients medically unfit for cisplatin or taxol chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 pre-operative chemoradiation	Arm 1 pre-operative chemoradiation	Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2
Arm 2 post operative chemoradiation	Arm 2 post operative chemoradiation	Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	up to 5 year

Secondary Outcome Measures

Name	Time	Method
R0 Resection Rate	At time of surgery
Overall Survival	up to 5 year

Trial Locations

Locations (3)

ziyang People's Hospital; 🇨🇳 Siyang, Sichuan, China

Xijing Hospital, GI institute; 🇨🇳 Xi'an, Shanxi, China

friendship Hospital; 🇨🇳 Chengdu, Sichuan, China