Trial comparing surgery first or chemotherapy first in stomach cancer
- Conditions
- Carcinoma stomach (gastric cancer)
- Registration Number
- CTRI/2013/05/003708
- Lead Sponsor
- South Indian Oncology Group
- Brief Summary
Purpose of study: To conduct a randomized, open label phase III trial of perioperative versus postoperative chemotherapy in patients with resectable gastric cancer.
***Primary objective*:** To compare overall survival and disease free survival in patients with locally advanced resectable gastric cancer treated with either perioperative or only postoperative chemotherapy
Hypothesis: The results of treatment of gastric cancer depend on the stage of the disease. Although early gastric cancer has a high curability rate, patients with advanced stage gastric cancer do not fare well even after complete surgical resection. The risk of recurrence increases as the disease stage increases. The failure after surgery with adequate lymphadenectomy is usually distant- either in the peritoneum or the liver, and only systemic chemotherapy can control micrometastatic disease. Also, in advanced stage gastric cancers, it may not be possible always to achieve an R0 resection due to the local/ regional extent of the disease. Adjuvant chemotherapy has not been shown to improve survival in most randomized controlled trials. The morbidity of surgery may also limit the ability to deliver postoperative chemotherapy effectively. Therefore, there is a lot of interest nowadays in neoadjuvant or preoperative chemotherapy. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Neoadjuvant chemotherapy has many theoretical advantages- it can treat micrometastatic disease at the earliest opportunity and it may downstage the tumor allowing complete resection. Neoadjuvant treatment in gastric cancer offers an opportunity to deliver systemic treatment when the patient is best able to tolerate it, since initiating postoperative chemotherapy is usually delayed following gastric cancer surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 350
- •Histologically proven adenocarcinoma of the stomach or Siewert type 3 adenocarcinoma of the gastroesophageal junction stage T2-4 Nx or Tx N+.
- •Resectable disease •No distant metastasis, including peritoneal carcinomatosis • No gastric outlet obstruction or uncontrolled bleeding •CT scan and diagnostic laparoscopy are mandatory •No prior therapy for the diagnosed gastric cancer Patient characteristics: •Age- 20 to 69 years •ECOG performance status 0-2 Hemopoetic- WBC > 4000/ cu.
- mm Absolute neutrophil count > 2000/cu.mm Platelet count > 100,000/ cu.mm Hepatic- bilirubin not more than 1.5 times upper limit of nomal, AST & ALT not more than 1.5 times upper limit of normal Renal- Creatinine not more than 1.25 times ULN, creatinine clearance > 60 ml/min Cardiovascular-no prior arrhythmias, no prior congestive cardiac failure, no myocardial infarction within past 6 months, no unstable cardiac disease requiring treatment, Ejection fraction >50% on echo Pulmonary- no evidence of severe obstructive or restrictive airway disease on pulmonary function tests.
•Not pregnant or nursing •Fertile patients must use effective contraception •No other prior or concurrent neoplasm except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin •No active infection •No allergy to protocol drugs •No history of significant neurologic or psychiatric disorders •No other serious medical condition that would prevent compliance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare overall survival and disease free survival in patients with locally advanced resectable gastric cancer treated with either perioperative or only postoperative chemotherapy Overall and disease-free survival will be analysed at 3 years and 5 years after completion of treatment
- Secondary Outcome Measures
Name Time Method 1. Evaluate toxicity of and disease response to neoadjuvant chemotherapy 2. Evaluate the postoperative complications following neoadjuvant chemotherapy
Trial Locations
- Locations (5)
Basavatarakam Indo-American Cancer Hospital and Research Institute
🇮🇳Hyderabad, ANDHRA PRADESH, India
Cancer Institute (WIA)
🇮🇳Chennai, TAMIL NADU, India
Christian Medical College Hospital
🇮🇳Vellore, TAMIL NADU, India
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, KARNATAKA, India
MNJ Institute of Oncology and Regional Cancer Center
🇮🇳Hyderabad, ANDHRA PRADESH, India
Basavatarakam Indo-American Cancer Hospital and Research Institute🇮🇳Hyderabad, ANDHRA PRADESH, IndiaDrT Subramanyeshwar RaoPrincipal investigator9848038716subramanyeswar@yahoo.com