Clinical trial NCT03223740: Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy
Official title: A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Locally Advanced Gastric Carcinoma
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Xijing Hospital
First posted: 2017-07-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Progression Free Survival
timeFrame: up to 5 year
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 5 year
measure: R0 Resection Rate
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, GI institute
state: Shanxi
city: Chengdu
country: China
facility: friendship Hospital
state: Sichuan
city: Siyang
country: China
facility: ziyang People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Academy of Medical Science
name: Ming Zeng, MD PhD
role: STUDY_CHAIR
affiliation: Xijing Hosptial, GI institute
name: Hongwei Zhang, MD PhD
role: STUDY_CHAIR
References: