Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy (President)

Sichuan Provincial People's Hospital

Status and phase: Unknown; Phase 3

Conditions: Locally Advanced Gastric Carcinoma

Treatments: Other: Arm 1 pre-operative chemoradiation; Other: Arm 2 post operative chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03223740

President Trial

Details and patient eligibility

About

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

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

Arm 1 pre-operative chemoradiation

Experimental group

Description:

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

Treatment:

Other: Arm 1 pre-operative chemoradiation

Arm 2 post operative chemoradiation

Active Comparator group

Description:

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

Treatment:

Other: Arm 2 post operative chemoradiation