A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00123318
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : June 18, 2013
The Royal Australian and New Zealand College of Radiologists
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)

Brief Summary:
The purpose of this study is to determine the side-effects and effectiveness of a new type of chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with radiotherapy.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: epirubicin Drug: cisplatin Drug: 5-fluorouracil Radiation: Radiotherapy Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Study Start Date : February 2003
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Epirubicin

Arm Intervention/treatment
Experimental: 1
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
Drug: epirubicin
50mg/m2 IV day 1
Other Name: Epirubicin Ebewe, Epirubicin Hydrochloride for Injection

Drug: cisplatin
60mg/m2 IV day 1
Other Name: Cisplatin Ebewe, Cisplatin Injection

Drug: 5-fluorouracil
5-FU 200mg/m2/d IV 21 day continuous infusion Cont. infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
Other Name: DBL Fluoruracil Injection BP, Efudix

Radiation: Radiotherapy
45Gy 25 Fractions, 5 days/week for 5 weeks
Other Name: Radiation

Primary Outcome Measures :
  1. The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity [ Time Frame: Final analysis will be at 3 years. ]
  2. The percentage of patients who complete the planned chemoradiation protocol [ Time Frame: Final analysis will be at 3 years. ]
  3. The percentage of major radiotherapy protocol violations [ Time Frame: Final analysis will be at 3 years. ]

Secondary Outcome Measures :
  1. Median survival and overall survival at 3 years [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 chemotherapy.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00123318

Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Nepean Cancer Care Centre
Penrith, New South Wales, Australia, 2751
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2069
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Australia, Queensland
Mater QRI
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
East Coast Cancer Centre
Tugun, Queensland, Australia, 4224
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Tasmania
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Austin Health
Melbourne, Victoria, Australia, 3081
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Alfred Hospital
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 4710
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
The Royal Australian and New Zealand College of Radiologists
Study Chair: Trevor Leong Peter MacCallum Cancer Centre, Australia

Additional Information:
Responsible Party: Trans-Tasman Radiation Oncology Group (TROG) Identifier: NCT00123318     History of Changes
Other Study ID Numbers: TROG 03.02
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors