Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

NCT03223740 | Unknown Phase 3 DMC

• 1 other identifier: President Trial
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  up to 5 year

Secondary Outcomes (2)

• Overall Survival

  up to 5 year

• R0 Resection Rate

  At time of surgery

Study Arms (2)

Arm 1 pre-operative chemoradiation

EXPERIMENTAL

Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2

Other: Arm 1 pre-operative chemoradiation

Arm 2 post operative chemoradiation

ACTIVE COMPARATOR

Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2

Other: Arm 2 post operative chemoradiation

Interventions

Arm 1 pre-operative chemoradiation OTHER

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.

Arm 1 pre-operative chemoradiation

Arm 2 post operative chemoradiation OTHER

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

Arm 2 post operative chemoradiation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Xijing Hospital: collaborator

Study Sites (3)

Xijing Hospital, GI institute

Xi’an, Shanxi, 710032, China

ACTIVE NOT RECRUITING

friendship Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

ziyang People's Hospital

Siyang, Sichuan, China

RECRUITING

Study Officials

• Ming Zeng, MD PhD

  Sichuan Academy of Medical Science

  STUDY CHAIR

• Hongwei Zhang, MD PhD

  Xijing Hosptial, GI institute

  STUDY CHAIR

Central Study Contacts

Qian Peng, MD PhD

CONTACT

008617708130617; pengqian0522@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2021
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

CN (3)