Suspended

Phase II Study of Postoperative Intensity-modulated Radiotherapy (IMRT) Combined With Capecitabine for Stage II/III Gastric Cancer Patients

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What is being tested

concurrent chemoradiation

Radiation
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2011
See protocol details

Summary

Principal SponsorChinese Academy of Medical Sciences
Study Contactjing jinMore contacts
Last updated: February 5, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2011

Actual date on which the first participant was enrolled.

In Intergroup 0116, only 64% patients in concurrent chemoradiation group completed treatment as planed, but in recently reported ARTIST trial, capecitabine was admitted to concurrent with radiotherapy,patients who completed treatment as planed in concurrent group reach high as 80%. IMRT is an advanced radiotherapy technology which allows high conformal dose distribution to Planing Tumor Volume (PTV) and low dose to organ at risk. The purpose of this study is to evaluate feasibility and efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients after D1/2 surgery.

NCT01674959
Principal SponsorChinese Academy of Medical Sciences
Study Contactjing jinMore contacts
Last updated: February 5, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

Inclusion Criteria: Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction. Age of 18 to 75, Karnofsky score higher than 70. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, without positive incisal margin. Stage II/III(AJCC 7th). No severe functional damage of major organ, normal blood cell, normal liver and kidney function. No clinical findings of distant metastasis. Predictive survival time longer than 6 months. - Exclusion Criteria: Peritoneal carcinomatosis, as diagnosed by mandatory laparoscopy or distant metastasis Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia) Active or uncontrolled infection. Definitive contraindications for the use of corticosteroids as premedication Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen Any contraindication to treatment with cetuximab, capecitabine or cisplatin Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer Known hypersensitivity against any of the study drugs ( capecitabine)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
• Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered. Postoperative current chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science

Beijing, ChinaOpen Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science in Google Maps
SuspendedOne Study Center