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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00123318




Registration number
NCT00123318
Ethics application status
Date submitted
19/07/2005
Date registered
22/07/2005
Date last updated
18/06/2013

Titles & IDs
Public title
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Scientific title
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Secondary ID [1] 0 0
TROG 03.02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - epirubicin
Treatment: Drugs - cisplatin
Treatment: Drugs - 5-fluorouracil
Treatment: Other - Radiotherapy

Experimental: 1 - Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)


Treatment: Drugs: epirubicin
50mg/m2 IV day 1

Treatment: Drugs: cisplatin
60mg/m2 IV day 1

Treatment: Drugs: 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

Treatment: Other: Radiotherapy
45Gy 25 Fractions, 5 days/week for 5 weeks
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Timepoint [1] 0 0
Final analysis will be at 3 years.
Primary outcome [2] 0 0
The percentage of patients who complete the planned chemoradiation protocol
Timepoint [2] 0 0
Final analysis will be at 3 years.
Primary outcome [3] 0 0
The percentage of major radiotherapy protocol violations
Timepoint [3] 0 0
Final analysis will be at 3 years.
Secondary outcome [1] 0 0
Median survival and overall survival at 3 years
Timepoint [1] 0 0
3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Nepean Cancer Care Centre - Penrith
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [7] 0 0
Westmead Hospital - Sydney
Recruitment hospital [8] 0 0
Mater QRI - Brisbane
Recruitment hospital [9] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [10] 0 0
East Coast Cancer Centre - Tugun
Recruitment hospital [11] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [13] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [14] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [15] 0 0
Austin Health - Melbourne
Recruitment hospital [16] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [17] 0 0
Alfred Hospital - Prahran
Recruitment hospital [18] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2751 - Penrith
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2050 - Sydney
Recruitment postcode(s) [6] 0 0
2069 - Sydney
Recruitment postcode(s) [7] 0 0
2145 - Sydney
Recruitment postcode(s) [8] 0 0
- Brisbane
Recruitment postcode(s) [9] 0 0
4029 - Herston
Recruitment postcode(s) [10] 0 0
4224 - Tugun
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [12] 0 0
7250 - Launceston
Recruitment postcode(s) [13] 0 0
- Box Hill
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3081 - Melbourne
Recruitment postcode(s) [16] 0 0
8006 - Melbourne
Recruitment postcode(s) [17] 0 0
3181 - Prahran
Recruitment postcode(s) [18] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Royal Australian and New Zealand College of Radiologists
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00123318
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Trevor Leong
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00123318