Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000382370
Ethics application status
Approved
Date submitted
22/07/2008
Date registered
1/08/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Phase II Trial of Weekly Docetaxel (Taxotere) Chemoradiotherapy +/- Cetuximab (Erbitux) for Localised Resectable Cancer of the Oesophagus
Scientific title
A Randomised Phase II Trial to evaluate the response of Weekly Docetaxel (Taxotere) Chemoradiotherapy +/- Cetuximab (Erbitux) for Localised Resectable Cancer of the Oesophagus
Universal Trial Number (UTN)
Trial acronym
DECO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Localised resectable cancer of the oesophagus 3442 0
Condition category
Condition code
Cancer 3596 3596 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arm: Induction chemotherapy: 2 cycles of 4 weeks of Docetaxel (D), Cisplatin (C), 5-fluorouracil (5FU) and Cetuximab: Docetaxel 35mg/m2 by intravenous drip on days 1, 8 and 15 of every 4 week cycle, Cisplatin 25mg/m2 by intravenous drip on days 1, 8 and15 of every 4 week cycle, 5FU, 150mg/m2/day by continuous infusion from days 1-21 of every 4 week cycle, Cetuximab initial dose 400mg/m2 by intravenous drip on day 1, then 250mg/m2 by intravenous drip on days 1, 8, 15 and 22 of every 4 week cycle, Chemotherapy break: 1 week prior to chemoradiotherapy, cetuximab given alone at 250mg/m2 by intravenous drip Chemoradiotherapy: 1 cycle of 5 weeks of Docetaxel (D), Cisplatin (C), Radiotherapy (RT) and Cetuximab: Docetaxel 35mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Cisplatin 25mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Radiotherapy 50.4 Gray (28 fractions/5 fractions per week) Cetuximab 250mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Surgery: Following restaging to exclude metastatic disease, surgery will be performed within 4-8 weeks of completion of chemoradiotherapy.
Intervention code [1] 3175 0
Treatment: Drugs
Comparator / control treatment
Control Arm: Induction chemotherapy: 2 cycles of 4 weeks of Docetaxel (D), Cisplatin (C) and 5-fluorouracil (5FU): Docetaxel 35mg/m2 by intravenous drip on days 1, 8 and 15 of every 4 week cycle Cisplatin 25mg/m2 by intravenous drip on days 1, 8 and15 of every 4 week cycle 5FU, 150mg/m2/day by continuous infusion from days 1-21 of every 4 week cycle Chemotherapy break: 1 week prior to the commencement of chemoradiotherapy Chemoradiotherapy: 1 cycle of 5 weeks of Docetaxel (D), Cisplatin (C) and Radiotherapy (RT): Docetaxel 35mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Cisplatin 25mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Radiotherapy 50.4 Gray (28 fractions/5 fractions per week) Surgery: Following restaging to exclude metastatic disease, surgery will be performed within 4-8 weeks of completion of chemoradiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 4533 0
Pathological complete response rate determined from surgical specimens in resectable patients
Timepoint [1] 4533 0
Surgery will be performed 4-8 weeks following completion of chemoradiotherapy in resectable patients
Secondary outcome [1] 7608 0
Disease-free survival
Timepoint [1] 7608 0
Progression status will be reviewed prior to surgery, and then every 3 months until disease progression.
Secondary outcome [2] 7670 0
Overall survival
Timepoint [2] 7670 0
Overall survival will be measured from date of patient entry onto the study to date of death from any cause. Following completion of study treatment, patients will be followed up every 3 months for a minimum of 3 years.
Secondary outcome [3] 7671 0
Toxicity as measured by adverse events. Examples include febrile neutropaenia, nausea, vomiting and oesophagitis, which will be measured by clinican assessment and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCICTCAEv3.0). Late radiation toxicities including lung, heart and spinal cord will be measured by clinician assessment and graded according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer(RTOG/EORTC) Late Radiation Morbidity Scoring Schema.
Timepoint [3] 7671 0
Adverse events will be assessed at baseline, at the end of every induction chemotherapy cycle, weekly during concurrent chemoradiotherapy, and 2 and 4 weeks post completion of chemoradiotherapy. Late radiation toxicities will then be assessed every 3 months for a minimum of 3 years.
Secondary outcome [4] 7672 0
Feasibility in terms of the extent of delivery of the planned treatment regimen
Timepoint [4] 7672 0
Extent of treatment delivery will be assessed at the completion of protocol treatment.
Secondary outcome [5] 7673 0
Early Fluorodeoxyglucose Positron Emission Tomography (FDG PET) response (where assessed).
Timepoint [5] 7673 0
FDG PET will be performed at baseline. Another FDG PET will be performed 14-21 days after the commencment of induction chemotherapy, where available.
Secondary outcome [6] 7674 0
Post-treatment Fluorodeoxyglucose Positron Emission Tomography (FDG PET) response rate (where assessed)
Timepoint [6] 7674 0
FDG PET will be performed at baseline. Another FDG PET will be performed 4-6 weeks following the completion of chemoradiotherapy, where available.

Eligibility
Key inclusion criteria
Adenocarcinoma of the oesophagus or oesophago-gastric junction, suitable for definitive surgical resection.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Distant visceral or nodal metastases.
Previous chemotherapy or radiotherapy for oesophageal cancer.
Carcinoma of the cervical oesophagus, or tumour predominantly in the stomach.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,TAS

Funding & Sponsors
Funding source category [1] 3624 0
Commercial sector/Industry
Name [1] 3624 0
Seed funding from Merck Serono
Country [1] 3624 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group (AGITG)
Address
National Health and Medical Research Council (NHMRC) Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 3259 0
None
Name [1] 3259 0
Address [1] 3259 0
Country [1] 3259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5676 0
Cancer Institute NSW Clinical Research Ethics Committeee
Ethics committee address [1] 5676 0
Ethics committee country [1] 5676 0
Australia
Date submitted for ethics approval [1] 5676 0
25/01/2008
Approval date [1] 5676 0
09/07/2008
Ethics approval number [1] 5676 0
2008c/02/040

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

Contacts
Principal investigator
Name 28772 0
Address 28772 0
Country 28772 0
Phone 28772 0
Fax 28772 0
Email 28772 0
Contact person for public queries
Name 11929 0
Michelle Cummins
Address 11929 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Country 11929 0
Australia
Phone 11929 0
02 9562 5000
Fax 11929 0
02 9562 5094
Email 11929 0
[email protected]
Contact person for scientific queries
Name 2857 0
Dr Michael Michael
Address 2857 0
Peter MacCallum Cancer Centre, Dept of Haematology and Medical Oncology, 1 St Andrews Place, East Melbourne, VIC
Country 2857 0
Australia
Phone 2857 0
03 9656 1111
Fax 2857 0
03 9656 1091
Email 2857 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.