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Trial registered on ANZCTR


Trial ID
ACTRN12605000106639
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
31/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II Study of Weekly Oxaliplatin With Continous Infusion Fluorouracil And Concurrent Radiation for Treatment of Localised Oesophageal Carcinoma
Scientific title
Phase II Study of Weekly Oxaliplatin With Continous Infusion Fluorouracil And Concurrent Radiation for Treatment and to determine response and local control of Localised Oesophageal Carcinoma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histologically confirmed localised squamous cell carcinoma of the oesophagus 189 0
Adenocarcinoma of the oesophagus 190 0
Condition category
Condition code
Cancer 213 213 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxaliplatin is designated chemically as [SP-4-2]-(1R,2R)-(cyclohexane-1,2-diamine-k2N,Nÿ¿ÿ´ (oxalato(2-)-k2O1,O2]platinum (II)
given by intravenous infusion.

This is a single arm open label Phase II study of chemo-radiation of localised oesophageal cancer with Oxaliplatin, continuous infusion fluorouracil and radiation.

The duration of the study participation will include for each patient a 1 week inclusion and treatment planning period, followed by a 6 week treatment period, followed by a minimum of 1 week follow-up for chemotherapy related toxicities after the completion of the study treatment. In addition all patients will be followed for radiation toxicity and disease status for 2 years after the completion of the study treatment.

Treatment Regimen:
*5-fluorouracil via continuous intravenous infusion at the dose of 225mg/m2/day commencing on first day of radiation and continuing until delivery of last radiation fraction.
*Oxaliplatin given by 2-hour intravenous infusion at a dose of 60mg/m2 weekly commencing immediately prior to the commencement of 5-fluorouracil
Radiation-Standard total 54 to 60 Gy, given daily apart from weekends and public holidays
Intervention code [1] 118 0
Treatment: drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 251 0
This trial will determine local control of oesophageal cancer after treatment with oxaliplatin, continuous infusion fluorouracil and radiation. The primary endpoints will be tumour response, local control, and toxicity.
The aim of this study is includes:
a)Determine response and local control of oesophageal cancer after treatment with oxaliplatin, continuous infusion fluorouracil and radiation.
Timepoint [1] 251 0
Primary outcome [2] 252 0
This trial will determine local control of oesophageal cancer after treatment with oxaliplatin, continuous infusion fluorouracil and radiation. The primary endpoints will be tumour response, local control, and toxicity.
The aim of this study is includes:
b)Determine the toxicity and change in quality of life in patients with oesophageal cancer after treatment with oxaliplatin, continuous infusion fluorouracil and radiation.
Timepoint [2] 252 0
Primary outcome [3] 253 0
This trial will determine local control of oesophageal cancer after treatment with oxaliplatin, continuous infusion fluorouracil and radiation. The primary endpoints will be tumour response, local control, and toxicity.
The aim of this study is includes:
c)Determine the time to progression and survival of patients with oesophageal cancer after treatment with oxaliplatin, continuous infusion fluorouracil and radiation.
Timepoint [3] 253 0
Secondary outcome [1] 575 0
Toxicity
Timepoint [1] 575 0
Secondary outcome [2] 576 0
Time to loco-regional failure
Timepoint [2] 576 0
Secondary outcome [3] 577 0
Failure free survival
Timepoint [3] 577 0
Secondary outcome [4] 578 0
Patterns of failure
Timepoint [4] 578 0
Secondary outcome [5] 579 0
Quality of Life
Timepoint [5] 579 0
Secondary outcome [6] 580 0
Safety will be determined through a review of adverse events, routine symptom assessment, and laboratory determinations.
Timepoint [6] 580 0

Eligibility
Key inclusion criteria
1.Histologically confirmed localised squamous cell carcinoma of the oesophagus or adenocarcinoma of the oesophagus. 2. Performance status 0 or 1. 3. No prior chemotherapy or radiotherapy. 4. Disease evaluated by either CT or endoscopy. 5. Geographically accessible. 6. No other severe medical illness which would contra-indicate the therapy. 7. Life expectancy of greater than 3 months. 8. Bone marrow function showing white cells greater than 3.0x109/L, neutrophils greater than 2.0x109/L, platelets greater than 100x109/L. 9. Creatinine less than 2x upper limit of normal. 10.Adequate methods of contraception.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Serious uncontrolled infection 2. Uncontrolled other malignancy 3. Concurrent treatment with other anti-cancer drugs 4. Respiratory function with FEV1 less than 1L 5. Oesophageal-bronchial fistula 6. Pregnancy or Lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)

Funding & Sponsors
Funding source category [1] 273 0
Hospital
Name [1] 273 0
Princess Alexandra Hospital,
Address [1] 273 0
Country [1] 273 0
Australia
Funding source category [2] 274 0
Commercial sector/Industry
Name [2] 274 0
Sanofi Synthelabo
Address [2] 274 0
Country [2] 274 0
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Country
Australia
Secondary sponsor category [1] 206 0
Commercial sector/Industry
Name [1] 206 0
Sanofi Synthelabo
Address [1] 206 0
Country [1] 206 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1122 0
Princess Alexandra Hospital
Ethics committee address [1] 1122 0
Ethics committee country [1] 1122 0
Australia
Date submitted for ethics approval [1] 1122 0
Approval date [1] 1122 0
Ethics approval number [1] 1122 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36344 0
Address 36344 0
Country 36344 0
Phone 36344 0
Fax 36344 0
Email 36344 0
Contact person for public queries
Name 9307 0
Dr Bryan Burmeister
Address 9307 0
Radiation Oncology Unit
Princess Alexandra Hospital
Level 2 Building 1
Ipswich Road
Woolloongabba QLD 4102
Country 9307 0
Australia
Phone 9307 0
+61 7 32406581
Fax 9307 0
+61 7 32402252
Email 9307 0
Bryan_Burmeister@health.qld.gov.au
Contact person for scientific queries
Name 235 0
Dr Bryan Burmeister
Address 235 0
Radiation Oncology Unit
Princess Alexandra Hospital
Level 2 Building 1
Ipswich Road
Woolloongabba QLD 4102
Country 235 0
Australia
Phone 235 0
+61 7 32406581
Fax 235 0
+61 7 32402252
Email 235 0
Bryan_Burmeister@health.qld.gov.au