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

NCT ID: NCT02296658

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stomach Neoplasms Chemoradiotherapy, Adjuvant Radiotherapy, Intensity-Modulated

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S-1 based chemoradiotherapy

S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.

Group Type EXPERIMENTAL

intensity-modulated radiotherapy

Intervention Type RADIATION

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.

S-1

Intervention Type DRUG

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

Interventions

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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.

Intervention Type RADIATION

S-1

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Wang Xin

Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Jin, MD

Role: CONTACT

[email protected]
+8613601365130

Facility Contacts

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Xin Wang, MD

Role: primary

[email protected]
+8613311583220

Other Identifiers

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NCC2013RE-088

Identifier Type: -

Identifier Source: org_study_id