A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Information source: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Cancer
Intervention: epirubicin (Drug); cisplatin (Drug); 5-fluorouracil (Drug); Radiotherapy (Radiation)
Phase: Phase 3
Status: Completed
Sponsored by: Trans-Tasman Radiation Oncology Group (TROG) Official(s) and/or principal investigator(s): Trevor Leong, Study Chair, Affiliation: Peter MacCallum Cancer Centre, Australia
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.
Clinical Details
Official title: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicityThe percentage of patients who complete the planned chemoradiation protocol The percentage of major radiotherapy protocol violations
Secondary outcome: Median survival and overall survival at 3 years
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Christchurch Hospital, Christchurch 4710, New Zealand
Liverpool Hospital, Liverpool, New South Wales 1871, Australia
Calvary Mater Newcastle, Newcastle, New South Wales 2298, Australia
Nepean Cancer Care Centre, Penrith, New South Wales 2751, Australia
Prince of Wales Hospital, Randwick, New South Wales 2031, Australia
Royal North Shore Hospital, Sydney, New South Wales 2069, Australia
Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia
Westmead Hospital, Sydney, New South Wales 2145, Australia
Mater QRI, Brisbane, Queensland, Australia
Royal Brisbane Hospital, Herston, Queensland 4029, Australia
East Coast Cancer Centre, Tugun, Queensland 4224, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia
Launceston General Hospital, Launceston, Tasmania 7250, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Andrew Love Cancer Care Centre, Geelong Hospital, Geelong, Victoria 3220, Australia
Austin Health, Melbourne, Victoria 3081, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria 8006, Australia
Alfred Hospital, Prahran, Victoria 3181, Australia
Sir Charles Gairdner Hospital, Perth, Western Australia 6009, Australia
Additional Information
Click here for more information about this study on the TROG official website
Starting date: February 2003
Last updated: June 17, 2013
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