Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
February 8, 2018 updated by: LI Ning, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase I Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors.
The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present.
Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer.
However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer.
The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days.
3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1.
Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral.
Imaging evaluation was performed 3 weeks after neoadjuvant treatment.
The radical operation and surgical procedure were determined on MDT discussion.
Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed.
A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Ning Li, MD
- Phone Number: 8610-87787625
- Email: lee_ak@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical stage T3-4N+M0
- Gastric cancer or Siewert II/III esophagogastric junction carcinoma;
- Pathologically confirmed adenocarcinoma;
- 18-75 years old, male or female;
- Karnofsky score >= 70;
- White blood cell count >= 4 x 109 / L; platelet count >= 100 x109/L; serum creatinine =< 1 x upper limit of normal, total bilirubin =< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =< 2.5 x upper limit of normal, alkaline phosphatase =< 5 x upper limit of normal.
Exclusion Criteria:
- Any chemotherapy or radiotherapy history before enrollment
- Siewert I EGJ cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypo-fractionated radiotherapy
Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer
|
Hypo-fractionated radiotherapy with fraction >2Gy .
S-1 80mg/m2/day, orally intake on radiotherapy days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum tolerated dose AND Dose limited toxicity
Time Frame: From date of enrollment until one month after chemo-radiotherapy
|
To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy
|
From date of enrollment until one month after chemo-radiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response rate
Time Frame: From date of enrollment until surgery, assessed up to 2 months
|
To evaluate the pathological response rate of gastric cancer after hypo-fractionated neoadjuvant radiotherapy
|
From date of enrollment until surgery, assessed up to 2 months
|
|
2-year disease-free survival
Time Frame: From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months
|
To evaluate the 2-year disease-free survival of gastric cancer after hypo-fractionated neoadjuvant radiotherapy
|
From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7.
- Li N, Wang X, Tang Y, Zhao D, Chi Y, Yang L, Jiang L, Jiang J, Liu W, Tang Y, Fang H, Liu Y, Song Y, Wang S, Jin J, Li Y. A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer. BMC Cancer. 2018 Aug 8;18(1):803. doi: 10.1186/s12885-018-4707-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
December 31, 2016
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
January 28, 2018
First Submitted That Met QC Criteria
February 8, 2018
First Posted (Actual)
February 9, 2018
Study Record Updates
Last Update Posted (Actual)
February 9, 2018
Last Update Submitted That Met QC Criteria
February 8, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMS-GIRO-G005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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