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Postoperative IMRT Combined With Capecitabine for Advanced Gastric Cancer Patients

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
concurrent chemoradiation
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, radiation, chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
  2. Age of 18 to 75, Karnofsky score higher than 70.
  3. 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).
  4. No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
  5. No clinical findings of distant metastasis.

  6. Predictive survival time longer than 6 months.

    -

Exclusion Criteria:

  1. Peritoneal carcinomatosis, as diagnosed by mandatory laparoscopy or distant metastasis
  2. Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry
  3. 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)
  4. Active or uncontrolled infection.
  5. Definitive contraindications for the use of corticosteroids as premedication
  6. Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
  7. Any contraindication to treatment with cetuximab, capecitabine or cisplatin
  8. Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
  9. Known hypersensitivity against any of the study drugs ( capecitabine)

Sites / Locations

  • Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

concurrent chemoradiation

Arm Description

• 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).

Outcomes

Primary Outcome Measures

feasibility of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
feasibility of concurrent IMRT combined with capecitabine is defined as toxicities (CTC-AE 3.0) and rate of patients complete concurrent chemoradiation according to protocol.

Secondary Outcome Measures

efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients in this trial is defined as 3-year overall survival and 3-year relapse free survival.

Full Information

First Posted
August 26, 2012
Last Updated
February 3, 2015
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01674959
Brief Title
Postoperative IMRT Combined With Capecitabine for Advanced Gastric Cancer Patients
Official Title
Phase II Study of Postoperative Intensity-modulated Radiotherapy (IMRT) Combined With Capecitabine for Stage II/III Gastric Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (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
No

5. Study Description

Brief Summary
Radiation therapy plus concurrent chemotherapy has been demonstrated a significant improvement in overall and disease-free survival according to Intergroup Trial 0116 in patients with gastric cancer after surgical complete resection. Advantage of application of IMRT has been shown in planning comparison studies for postoperative gastric patients. So the investigators designed the trial to see safety and efficacy of postoperative concurrent chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, radiation, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
concurrent chemoradiation
Arm Type
Experimental
Arm Description
• 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).
Intervention Type
Radiation
Intervention Name(s)
concurrent chemoradiation
Intervention Description
postoperative Intensity-modulated radiotherapy (IMRT) combined with capecitabine for high risk gastric cancer patients 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 chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).
Primary Outcome Measure Information:
Title
feasibility of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
Description
feasibility of concurrent IMRT combined with capecitabine is defined as toxicities (CTC-AE 3.0) and rate of patients complete concurrent chemoradiation according to protocol.
Time Frame
3 months after concurrent chemoradiation
Secondary Outcome Measure Information:
Title
efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
Description
efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients in this trial is defined as 3-year overall survival and 3-year relapse free survival.
Time Frame
3 years after concurrent chemoradiation

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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jing jin
Phone
8610-87788280
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
hua ren
Phone
8610-87788122
Email
renhua2009@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jing jin, professor
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing jin
Phone
8610-87788280
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name & Degree
hua ren
Phone
8610-87788122
Email
renhua2009@hotmail.com
First Name & Middle Initial & Last Name & Degree
jing jin, professor

12. IPD Sharing Statement

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Postoperative IMRT Combined With Capecitabine for Advanced Gastric Cancer Patients

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