A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

June 17, 2013 updated by: Trans Tasman Radiation Oncology Group
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 1871
        • Liverpool Hospital
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Penrith, New South Wales, Australia, 2751
        • Nepean Cancer Care Centre
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australia, 2145
        • Westmead Hospital
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2069
        • Royal North Shore Hospital
    • Queensland
      • Brisbane, Queensland, Australia
        • Mater QRI
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • Tugun, Queensland, Australia, 4224
        • East Coast Cancer Centre
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Box Hill, Victoria, Australia
        • Box Hill Hospital
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Care Centre, Geelong Hospital
      • Melbourne, Victoria, Australia, 3081
        • Austin Health
      • Melbourne, Victoria, Australia, 8006
        • Peter MacCallum Cancer Centre
      • Prahran, Victoria, Australia, 3181
        • Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • New Zealand
      • Christchurch, New Zealand, 4710
        • Christchurch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Epirubicin Ebewe, Epirubicin Hydrochloride for Injection
Drug: cisplatin
60mg/m2 IV day 1
Other Names:
  • 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 Names:
  • DBL Fluoruracil Injection BP, Efudix
Radiation: Radiotherapy
45Gy 25 Fractions, 5 days/week for 5 weeks
Other Names:
  • Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Final analysis will be at 3 years.
The percentage of patients who complete the planned chemoradiation protocol
Time Frame: Final analysis will be at 3 years.
Final analysis will be at 3 years.
The percentage of major radiotherapy protocol violations
Time Frame: Final analysis will be at 3 years.
Final analysis will be at 3 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Median survival and overall survival at 3 years
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

The Royal Australian and New Zealand College of Radiologists

Investigators

  • Study Chair: Trevor Leong, Peter MacCallum Cancer Centre, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 19, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 03.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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