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Trial registered on ANZCTR


Registration number
ACTRN12606000526572
Ethics application status
Approved
Date submitted
22/12/2003
Date registered
22/12/2003
Date last updated
12/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Advanced oesophageal cancer study to compare quality of life and palliation of dysphagia
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 03.01 - A randomised phase III study in advanced oesophageal cancer to compare quality of life and palliation of dysphagia in patients treated with radiotherapy versus chemo-radiotherapy (cisplatin & 5-Flurouracil).
Secondary ID [1] 251990 0
clinicalTrials.gov ID NCT00193882
Universal Trial Number (UTN)
Trial acronym
TROG 03.01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced oesophagus cancer, not suitable for radical treatment. 43 0
Condition category
Condition code
Cancer 50 50 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 2: Chemo-radiotherapy. 35Gy in 15 fractions (Overall, treatment time will not exceed 25 days total for the 3 week course and 18 days for the 2 week course of radiation) plus Cisplatin 80mg/m squared IV day 1 (or 20mg/m sqaured/day IV each day from 1-4 only one cycle) plus 5-Fluorouacil 800mg/m squared/day IV days 1-4 (radiotherapy and chemotherapy are simultaneous)
Intervention code [1] 1300 0
Treatment: Drugs
Comparator / control treatment
Arm 1: Radiotherapy alone. 35 Gy in 15 fractions. Overall, treatment time will not exceed 25 days total for the 3 week course and 18 days for the 2 week course of radiation.
Control group
Active

Outcomes
Primary outcome [1] 83 0
Relief of dysphagia. Defined as improvment of at least one point on the Mellow scale.
Timepoint [1] 83 0
This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
Secondary outcome [1] 157 0
1. Dysphagia progression free survival.
Timepoint [1] 157 0
Measured from randomisation to the time of first progression of dysphagia. Progression will be defined as a drop of at least one point on the scale or stricture requiring intervention or death. Measured weeks 5 & 9 after the start of treatment, every month until one year post randomisation, then 3 monthly for two years and then yearly until death (all patients).
Secondary outcome [2] 158 0
2. Time to achieve any response in dysphagia.
Timepoint [2] 158 0
Measured weeks 5 & 9 after the start of treatment, every month until one year post randomisation, then 3 monthly for two years and then yearly until death (all patients).
Secondary outcome [3] 159 0
3. Quality of Life
Timepoint [3] 159 0
Differences post treatment (at the end of the treatment cycles) and at monthly intervals for the first 12 months and then 3 monthly until death (all patients).
Secondary outcome [4] 160 0
4. Acute and late toxicity.
Timepoint [4] 160 0
Measured weeks 5 & 9 after the start of treatment, every month until one year post randomisation, then 3 monthly for two years and then yearly until death (all patients).
Secondary outcome [5] 161 0
5. Survival.
Timepoint [5] 161 0
All patients followed until death.

Eligibility
Key inclusion criteria
1. Biopsy proven carcinoma of the Oesophagus
2. Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness (it should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment).
3. Symptomatic patients with dysphagia scores of => 1 i.e. able to eat only some sollids (see appendix 1)
4. Performance status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
5. Patients msut begin treatment within 2 weeks of randomisation
6. Patient is at least 18 years old
7. Adequate haematology function to undergo chemotherapy Peripheral blood - Neutrophils > 1.5 x 109/L - Platelets > 100 x 109/L
8. Adequate renal function, Creatine - Calculated clearence 50 ml/min (see appendix 1).
9. Patients capable of child bearing are using adequate contraception.
10. Written informed consent of patient.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest.
2. Synchronous active malignancies.
3. Pregnant or lactating patients.
4. Patients unfit for any treatment component.
5. Tracheo-oesophageal fistula.
6. Stents in situ.
7. Previous chemotherapy for Oesophageal Cancer
8. CT scan of thorax and abdomen more than 8 weeks prior to randomisation
9. Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomisation

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors: Presence of Metastases, Dysphagia score, Insititution. Simple randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2003
Actual
7/07/2003
Date of last participant enrolment
Anticipated
Actual
20/03/2012
Date of last data collection
Anticipated
Actual
20/03/2013
Sample size
Target
220
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 5242 0
Canada
State/province [1] 5242 0
Country [2] 5243 0
New Zealand
State/province [2] 5243 0
Country [3] 5244 0
United Kingdom
State/province [3] 5244 0

Funding & Sponsors
Funding source category [1] 70 0
Government body
Name [1] 70 0
National Health & Medical Research Council
Country [1] 70 0
Australia
Funding source category [2] 71 0
Government body
Name [2] 71 0
Cancer Council Tasmania
Country [2] 71 0
Australia
Funding source category [3] 72 0
Government body
Name [3] 72 0
National Cancer Institute of Canada
Country [3] 72 0
Canada
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group
Address
TROG Central Operations Office
Calvary Mater Newcastle
MHAB Level 5
Edith Street
Waratah, NSW
2310
Country
Australia
Secondary sponsor category [1] 58 0
Other
Name [1] 58 0
National Cancer Institute of Canada (NCIC)
Address [1] 58 0
10 Alcorn Avenue, Suite 200 Toronto, Ontario M4V 3B1
Country [1] 58 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 523 0
AHSC St John Regional Health
Ethics committee address [1] 523 0
Ethics committee country [1] 523 0
Canada
Date submitted for ethics approval [1] 523 0
Approval date [1] 523 0
01/11/1999
Ethics approval number [1] 523 0
Ethics committee name [2] 524 0
Box Hill Hospital
Ethics committee address [2] 524 0
Ethics committee country [2] 524 0
Australia
Date submitted for ethics approval [2] 524 0
Approval date [2] 524 0
Ethics approval number [2] 524 0
Ethics committee name [3] 525 0
Cancer Care Manitoba
Ethics committee address [3] 525 0
Ethics committee country [3] 525 0
Canada
Date submitted for ethics approval [3] 525 0
Approval date [3] 525 0
Ethics approval number [3] 525 0
Ethics committee name [4] 526 0
Christchurch Hospital
Ethics committee address [4] 526 0
Ethics committee country [4] 526 0
New Zealand
Date submitted for ethics approval [4] 526 0
Approval date [4] 526 0
Ethics approval number [4] 526 0
Ethics committee name [5] 527 0
Cross Cancer Institute
Ethics committee address [5] 527 0
Ethics committee country [5] 527 0
Canada
Date submitted for ethics approval [5] 527 0
Approval date [5] 527 0
Ethics approval number [5] 527 0
Ethics committee name [6] 528 0
Geelong Hospital
Ethics committee address [6] 528 0
Ethics committee country [6] 528 0
Australia
Date submitted for ethics approval [6] 528 0
Approval date [6] 528 0
Ethics approval number [6] 528 0
Ethics committee name [7] 529 0
Grand River Regional Cancer Centre
Ethics committee address [7] 529 0
Ethics committee country [7] 529 0
Canada
Date submitted for ethics approval [7] 529 0
Approval date [7] 529 0
Ethics approval number [7] 529 0
Ethics committee name [8] 530 0
Hotel-Dieu de Quebec
Ethics committee address [8] 530 0
Ethics committee country [8] 530 0
Canada
Date submitted for ethics approval [8] 530 0
Approval date [8] 530 0
Ethics approval number [8] 530 0
Ethics committee name [9] 531 0
Kingston Regional Cancer centre
Ethics committee address [9] 531 0
Ethics committee country [9] 531 0
Canada
Date submitted for ethics approval [9] 531 0
Approval date [9] 531 0
Ethics approval number [9] 531 0
Ethics committee name [10] 532 0
Liverpool Hospital
Ethics committee address [10] 532 0
Ethics committee country [10] 532 0
Australia
Date submitted for ethics approval [10] 532 0
Approval date [10] 532 0
Ethics approval number [10] 532 0
Ethics committee name [11] 533 0
Mater QRI
Ethics committee address [11] 533 0
Ethics committee country [11] 533 0
Australia
Date submitted for ethics approval [11] 533 0
Approval date [11] 533 0
Ethics approval number [11] 533 0
Ethics committee name [12] 534 0
Nova Scotia Cancer centre
Ethics committee address [12] 534 0
Ethics committee country [12] 534 0
Canada
Date submitted for ethics approval [12] 534 0
Approval date [12] 534 0
Ethics approval number [12] 534 0
Ethics committee name [13] 535 0
Peter MacCallum Cancer Centre
Ethics committee address [13] 535 0
Ethics committee country [13] 535 0
Australia
Date submitted for ethics approval [13] 535 0
Approval date [13] 535 0
Ethics approval number [13] 535 0
Ethics committee name [14] 536 0
Princess Alexandra Hospital
Ethics committee address [14] 536 0
Ethics committee country [14] 536 0
Australia
Date submitted for ethics approval [14] 536 0
Approval date [14] 536 0
Ethics approval number [14] 536 0
Ethics committee name [15] 537 0
Prince of Wales Hospital
Ethics committee address [15] 537 0
Ethics committee country [15] 537 0
Australia
Date submitted for ethics approval [15] 537 0
Approval date [15] 537 0
Ethics approval number [15] 537 0
Ethics committee name [16] 538 0
Princess Margaret Hospital
Ethics committee address [16] 538 0
Ethics committee country [16] 538 0
Canada
Date submitted for ethics approval [16] 538 0
Approval date [16] 538 0
Ethics approval number [16] 538 0
Ethics committee name [17] 539 0
Queen Elizabeth Hospital
Ethics committee address [17] 539 0
Ethics committee country [17] 539 0
Australia
Date submitted for ethics approval [17] 539 0
Approval date [17] 539 0
Ethics approval number [17] 539 0
Ethics committee name [18] 540 0
Royal Adelaide Hospital
Ethics committee address [18] 540 0
Ethics committee country [18] 540 0
Australia
Date submitted for ethics approval [18] 540 0
Approval date [18] 540 0
Ethics approval number [18] 540 0
Ethics committee name [19] 541 0
Royal Perth Hospital
Ethics committee address [19] 541 0
Ethics committee country [19] 541 0
Australia
Date submitted for ethics approval [19] 541 0
Approval date [19] 541 0
Ethics approval number [19] 541 0

Summary
Brief summary
People with cancer of the oesophagus (gullet) often have trouble swallowing. Radiotherapy can help improve this problem. Using chemotherapy together with radiotherapy may work better but has more side effects. This trial will determine if it is better to use radiotherapy by itself or together with chemotherapy.
Trial website
Trial related presentations / publications
Abstract 66: Penniment M. A randomized phase III study in advanced esophageal cancer (OC) to compare the quality of life (QoL) and palliation of dysphagia in patients treated with radiotherapy (RT) or chemoradiotherapy (CRT) TROG 03.01 NCIC CTG ES.2. ASCO May 30-June 2, Chicago Illinois. Poster presentation.
Public notes

Contacts
Principal investigator
Name 35188 0
Dr Michael Penniment
Address 35188 0
Royal Adelaide Hospital
North Terrace
Adelaide SA, 5000
Country 35188 0
Australia
Phone 35188 0
+61 8 8222 4000
Fax 35188 0
Email 35188 0
[email protected]
Contact person for public queries
Name 10489 0
Sonya Stephens
Address 10489 0
Royal Adelaide Hospital
Radiation Oncology
North Terrace
Adelaide SA 5000
Country 10489 0
Australia
Phone 10489 0
+61 8 8222 4042
Fax 10489 0
Email 10489 0
[email protected]
Contact person for scientific queries
Name 1417 0
Michael Penniment
Address 1417 0
Royal Adelaide Hospital
Radiation Oncology
North Terrace ADELAIDE SA 5000
Country 1417 0
Australia
Phone 1417 0
+61 8 8222 4000
Fax 1417 0
Email 1417 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4212Study results articleYes Penniment M, De Ieso P, Harvey J, Stephens S, Au H... [More Details]
4213Other filesNo Penniment M G; Harvey JA; Wong R; et al. Best Prac... [More Details]

Documents added automatically
No additional documents have been identified.