Back to resultsA Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
Primary Purpose
Stomach Neoplasms, Chemoradiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
intensity-modulated radiotherapy
S-1
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
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
Sites / Locations
- Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-1 based chemoradiotherapy
Arm Description
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
Outcomes
Primary Outcome Measures
Disease free survival
Locoregional recurrence free survival
Overall survival
Distant metastasis free survival
Secondary Outcome Measures
Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0
Full Information
NCT ID
NCT02296658
First Posted
November 18, 2014
Last Updated
November 19, 2014
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02296658
Brief Title
A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
Official Title
A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Chemoradiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-1 based chemoradiotherapy
Arm Type
Experimental
Arm Description
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiotherapy
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
3 years
Title
Locoregional recurrence free survival
Time Frame
3 years
Title
Overall survival
Time Frame
3 years
Title
Distant metastasis free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0
Time Frame
during treatment and within the first 30 days after completion of chemoradiotherapy
Other Pre-specified Outcome Measures:
Title
Comparison of dosimetric differences between radiation techniques
Description
To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, MD
Phone
+8613601365130
Email
jingjin1025@163.com
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD
Phone
+8613311583220
Email
beryl_wx2000@163.com
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
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