Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

NCT ID: NCT03223740

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1 pre-operative chemoradiation

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

Group Type: EXPERIMENTAL

Arm 1 pre-operative chemoradiation

Intervention Type: 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 2 post operative chemoradiation

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

Group Type: ACTIVE_COMPARATOR

Arm 2 post operative chemoradiation

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

ming zeng, MD

Director of Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Zeng, MD PhD

Role: STUDY_CHAIR

Sichuan Academy of Medical Science

Hongwei Zhang, MD PhD

Role: STUDY_CHAIR

Xijing Hosptial, GI institute

Locations

Xijing Hospital, GI institute

Xi’an, Shanxi, China

Site Status: ACTIVE_NOT_RECRUITING

friendship Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

ziyang People's Hospital

Siyang, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian Peng, MD PhD

Role: CONTACT

pengqian0522@163.com

008617708130617

Facility Contacts

lili deng, MD

Role: primary

+8613880926676

min wei, MD

Role: primary

+8613980386078

Other Identifiers

President Trial

Identifier Type: -

Identifier Source: org_study_id