Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy (President)

A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer

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

Study Overview

• Status: Unknown
• Conditions: Locally Advanced Gastric Carcinoma
• Intervention / Treatment: Other: Arm 1 pre-operative chemoradiation; Other: Arm 2 post operative chemoradiation

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qian Peng, MD PhD; Phone Number: 008617708130617; Email: pengqian0522@163.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Active, not recruiting
      • Xijing Hospital, GI institute
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • friendship Hospital
      • Contact: lili deng, MD; Phone Number: +8613880926676
    • Siyang, Sichuan, China
      • Recruiting
      • Ziyang People's Hospital
      • Contact: min wei, MD; Phone Number: +8613980386078

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 pre-operative chemoradiation; Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2	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.
Active Comparator: Arm 2 post operative chemoradiation; Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	up to 5 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	up to 5 year
R0 Resection Rate	At time of surgery

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Collaborators: Xijing Hospital
• Investigators: Study Chair: Ming Zeng, MD PhD, Sichuan Academy of Medical Science; Study Chair: Hongwei Zhang, MD PhD, Xijing Hosptial, GI institute

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: President Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED