Postoperative IMRT Combined With Capecitabine for Advanced Gastric Cancer Patients
Phase II Study of Postoperative Intensity-modulated Radiotherapy (IMRT) Combined With Capecitabine for Stage II/III Gastric Cancer Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Oct 2011
Longer than P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 26, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 5, 2015
February 1, 2015
4.2 years
August 26, 2012
February 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months after concurrent chemoradiation
Secondary Outcomes (1)
efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
3 years after concurrent chemoradiation
Study Arms (1)
concurrent chemoradiation
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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jing jin, professor
Cancer Hospital Chinese Academy of Medical Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending doctor of Dept. radiation oncology, Cancer Hospital
Study Record Dates
First Submitted
August 26, 2012
First Posted
August 29, 2012
Study Start
October 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
February 5, 2015
Record last verified: 2015-02