A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
1 other identifier
interventional
52
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
Started Feb 2003
Longer than P75 for phase_3 gastric-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 19, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJune 18, 2013
June 1, 2013
9 years
July 19, 2005
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Final analysis will be at 3 years.
The percentage of patients who complete the planned chemoradiation protocol
Final analysis will be at 3 years.
The percentage of major radiotherapy protocol violations
Final analysis will be at 3 years.
Secondary Outcomes (1)
Median survival and overall survival at 3 years
3 years
Study Arms (1)
1
EXPERIMENTALSingle-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
Interventions
50mg/m2 IV day 1
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
Eligibility Criteria
You may qualify if:
- All of the following must apply:
- Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is:
- completely resected with negative margins
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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 Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2069, 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
Christchurch Hospital
Christchurch, 4710, New Zealand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Trevor Leong
Peter MacCallum Cancer Centre, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2005
First Posted
July 22, 2005
Study Start
February 1, 2003
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
June 18, 2013
Record last verified: 2013-06