A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer

Trial Title: A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer

NCT ID: NCT02296658

Condition: Stomach Neoplasms
Chemoradiotherapy, Adjuvant
Radiotherapy, Intensity-Modulated

Conditions: Official terms:
Stomach Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: intensity-modulated radiotherapy
Description: A total irradiation dose of 45 Gy was delivered in daily 1.8-Gy fractions (5 days a week over 5 weeks) to all patients.
Arm group label: S-1 based chemoradiotherapy

Intervention type: Drug
Intervention name: S-1
Description: S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.
Arm group label: S-1 based chemoradiotherapy

Summary: The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection - Any prior chemotherapy is allowed in this protocol - No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation - No prior abdominal or pelvic radiotherapy - Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months - Patients must have normal organ and marrow function as defined below: - Leukocytes greater than or equal to 3,000 G/L - Platelets: greater than or equal to 100,000/mm3 - Hemoglobin:greater than or equal to 10g/L - Total bilirubin: within normal institutional limits - AST/ALT: less than or equal to 1.5 times the upper limit - Creatinine within normal upper limits - Informed consent Exclusion Criteria: - Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer - With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation - History of allergic reactions attributed to similar chemical or biologic complex to S-1 - Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness - History of myocardial infarction within the past 6 months or history of ventricular arrhythmia - History of prior radiation to the abdomen - Pregnant or lactating females

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Address:
City: Beijing
Zip: 100021
Country: China

Status: Recruiting

Contact:
Last name: Xin Wang, MD

Phone: +8613311583220
Email: beryl_wx2000@163.com

Start date: January 2014

Completion date: December 2016

Lead sponsor:
Agency: Chinese Academy of Medical Sciences
Agency class: Other

Source: ChineseAMS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02296658