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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 (TROG)
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/show/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
Other publications