Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

Locally Advanced Gastric Carcinoma Clinical Trial

— President  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03223740
• Other study ID #: President Trial
• Status: Recruiting
• Phase: Phase 3
• First received: July 18, 2017
• Last updated: August 16, 2017
• Start date: September 2016
• Est. completion date: October 2021

Study information

• Verified date: August 2017
• Source: Sichuan Provincial People's Hospital
• Contact: Qian Peng, MD PhD
• Phone: 008617708130617
• Email: pengqian0522[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: October 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Gastric Carcinoma
• Stomach Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
China	friendship Hospital	Chengdu	Sichuan
China	ziyang People's Hospital	Siyang	Sichuan
China	Xijing Hospital, GI institute	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital	Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		up to 5 year
Secondary	Overall Survival		up to 5 year
Secondary	R0 Resection Rate		At time of surgery