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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients

Outcome 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.

Outcome Time Frame:

3 months after concurrent chemoradiation

Safety Issue:

Yes

Principal Investigator

jing jin, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Science

Authority:

China: Food and Drug Administration

Study ID:

2011 CH-GI-024

NCT ID:

NCT01674959

Start Date:

October 2011

Completion Date:

December 2017

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • radiation
  • chemotherapy
  • Stomach Neoplasms

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