A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
The Royal Australian and New Zealand College of Radiologists
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00123318
First received: July 19, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: epirubicin
Drug: cisplatin
Drug: 5-fluorouracil
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • The percentage of patients who complete the planned chemoradiation protocol [ Time Frame: Final analysis will be at 3 years. ] [ Designated as safety issue: No ]
  • The percentage of major radiotherapy protocol violations [ Time Frame: Final analysis will be at 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median survival and overall survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: February 2003
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123318

Locations
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
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Austin Health
Melbourne, Victoria, Australia, 3081
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
Investigators
Study Chair: Trevor Leong Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00123318     History of Changes
Other Study ID Numbers: TROG 03.02
Study First Received: July 19, 2005
Last Updated: June 17, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Cisplatin
Epirubicin
Fluorouracil
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 30, 2014