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A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Phase 3
18 Years
Not Enrolling
Gastric Cancer

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Trial Information

A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

It has been shown recently in a study conducted in the USA (INT0116) that postoperative,
adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This
treatment is relatively new and there remains debate regarding the optimal chemotherapy
regimen and the optimal method of radiotherapy delivery. This study will evaluate a new
regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as
the systemic component given before and after concurrent chemoradiation with continuous
infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by
chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one
month later two further cycles of ECF are given. All patients are treated using
multiple-field conformal radiation techniques.

The specific objectives of the study are:

- To detail the acute toxicity associated with this treatment.

- To determine the feasibility of the proposed concurrent chemoradiation regimen.

- To determine the feasibility of a standardized technique for radiation treatment
planning and delivery.

The study will help to develop a common approach to the adjuvant treatment of gastric
cancer, which is required before initiating further clinical trials in gastric cancer.

Inclusion Criteria:

All of the following must apply:

- Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction
that is:

1. completely resected with negative margins

2. Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be
entered on the study at the discretion of the treating clinician.

- Age greater than or equal to 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

- Adequate organ function defined as follows:

- Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count
greater than or equal to 1.5 x 10^9 /L; Platelet count greater than or equal to
100 x 10^9 /L

- Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less
than or equal to 3.0 x ULN;

- Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated
creatinine clearance greater than or equal to 50mL/min.

- Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is
to be assessed by a dietician prior to commencing treatment.

- Disease which can be radically treated to 45 Gy with standard fractionation.

- Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF

- Written informed consent

Exclusion Criteria:

None of the following must apply:

- Evidence of metastatic disease.

- Prior chemotherapy or radiotherapy

- Patients with other significant underlying medical conditions that may be aggravated
by the study treatment or are not controlled.

- Pregnant or lactating females or female patients of childbearing potential who have
not been surgically sterilized or are without adequate contraceptive measures.

- Cardiac failure (relevant to the use of epirubicin):

- Patients with myocardial infarction within the last 6 months;

- Patients with New York Heart Association class III/IV congestive heart failure

Type of Study:


Study Design:

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

Outcome Measure:

The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity

Outcome Time Frame:

Final analysis will be at 3 years.

Safety Issue:


Principal Investigator

Trevor Leong

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TROG 03.02



Start Date:

February 2003

Completion Date:

February 2012

Related Keywords:

  • Gastric Cancer
  • Gastric cancer
  • Radiotherapy
  • Chemotherapy
  • Chemoradiation
  • Stomach Neoplasms