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

Stomach Neoplasms Clinical Trial

Official title:

A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02296658
• Other study ID #: NCC2013RE-088
• Status: Unknown status
• Phase: Phase 2
• First received: November 18, 2014
• Last updated: November 19, 2014
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Jin, MD
• Phone: +8613601365130
• Email: jingjin1025[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemoradiotherapy, Adjuvant
• Radiotherapy, Intensity-Modulated
• Stomach Neoplasms

Intervention

Radiation:
• intensity-modulated radiotherapy
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.

Drug:
• S-1
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of dosimetric differences between radiation techniques	To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning.	1 year
Primary	Disease free survival		3 years
Primary	Locoregional recurrence free survival		3 years
Primary	Overall survival		3 years
Primary	Distant metastasis free survival		3 years
Secondary	Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0		during treatment and within the first 30 days after completion of chemoradiotherapy