Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000026628
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
19/07/2005
Date last updated
14/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II study of fixed dose rate Gemcitabine-Oxaliplatin Integrated with concomitant 5FU and 3-D Conformal Radiotherapy for the treatment of localised pancreatic cancer: GOFURTGO
Scientific title
Phase II study of fixed dose rate Gemcitabine-Oxaliplatin Integrated with concomitant 5FU and 3-D Conformal Radiotherapy for the treatment of localised pancreatic cancer: GOFURTGO
Secondary ID [1] 253298 0
GOFURTGO
Universal Trial Number (UTN)
Trial acronym
GOFURTGO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced or locally recurrent inoperable pancreatic cancer not previously treated with chemotherapy or radiotherapy. 89 0
Condition category
Condition code
Cancer 110 110 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients enrolled in the study will receive the same treatment consisting of all of the following:
a) 1 cycle of chemotherapy: the cycle is 28 days (gemcitabine on days 1 and 15 and oxaliplatin on days 2 and 16, followed by:
b)radiotherpay plus continuous 5FU infusion: 5FU is given continuously (7 days a week for 6 weeks), radiotherpay is given 5 days a week (Mon-Fri) for 6 weeks followed by:
c) 3 cycles of chemotherapy: each cycle is 28 days (gemcitabine on days 1 and 15 and oxaliplatin on days 2 and 16
Intervention code [1] 36 0
Treatment: Other
Comparator / control treatment
This is a single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 136 0
The primary objective is to determine the proportions of patients starting and finishing greater than or equal to 80% of the planned dose on time for each component of the treatment.
Timepoint [1] 136 0
The outcome will be measured once all patients have enrolled and have completeed the study treatment.
Secondary outcome [1] 307 0
Adverse events
Timepoint [1] 307 0
Assessed at the end of ecah treatment cycle, and at end of treatment.
Secondary outcome [2] 308 0
Objective tumour response rates
Timepoint [2] 308 0
Before and after radiotherapy, at the end of treatment, and then as clinically indicated.
Secondary outcome [3] 309 0
Time to progression
Timepoint [3] 309 0
Before and after radiotherapy, at the end of treatment, and then as clinically indicated.
Secondary outcome [4] 310 0
CA 19-9 response rates
Timepoint [4] 310 0
Before and after radiotherapy, at the end of treatment, and then 2 monthly during follow up.
Secondary outcome [5] 311 0
Health-related quality of life.
Timepoint [5] 311 0
Before and after radiotherapy, at the end of treatment, and then 2 monthly until progression/disease recurrence.

Eligibility
Key inclusion criteria
Patient must have histologically/cytologically proven adenocarcinoma of the pancreas located in the head or the body of the pancreas (primary) or in the pancreatic bed (locally recurrent).Locoregional disease must be confirmed by dual phase CT (arterial and portal phases) without distant metastases (confirmed by CT of the chest, abdomen and pelvis).Patients must be assessed by a surgeon and considered inoperable.Performance status must be ECOG grade 0, 1 or 2.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Histological types other than pancreatic ductal adenocarcinoma
2. Metastatic disease.
3. Tumours of the tail of pancreas
4. Major co-morbid illnesses that, in the opinion of the investigator, would jeopardise the likely completion of the treatment program
5. Patients with peripheral sensory neuropathy with functional impairment.
6. Derangement of LFTs consistent with hepatic cellular dysfunction (ALT and/or AST >3 times upper limit of normal), or a bilirubin >3 times upper limit of normal. Patients with LFTs consistent with hepatic obstruction that is relieved (eg. by stenting, bypass) are eligible, provided the bilirubin has fallen to <3 times upper limit of normal.
7. Patients with significant loss of bodyweight, who, at the investigator’s discretion, is deemed not suitable for this study (eg.>15% weight loss since surgery or diagnosis)
8. Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
9. Treatment with any previous cytotoxic chemotherapy for this malignancy. Previous hormonal manipulation (including HRT) is allowed.
10. Previous abdominal radiotherapy
11. A previous history of malignancy other than non-melanomatous skin cancers, in –situ carcinoma, or patients who are disease–free from non-pancreatic tumours treated definitively more than 5 years ago.
12. Pregnant or lactating women, or women of childbearing potential not using adequate contraception.

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)
Paper enrolment through the AGITG Coordinating Centre, NHMRC Clinical Trials Centre
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 149 0
Commercial sector/Industry
Name [1] 149 0
Sanofi-Aventis
Country [1] 149 0
Australia
Funding source category [2] 150 0
Other Collaborative groups
Name [2] 150 0
AGITG
Country [2] 150 0
Australia
Funding source category [3] 151 0
University
Name [3] 151 0
CTC
Country [3] 151 0
Australia
Primary sponsor type
Other Collaborative groups
Name
AGITG
Address
92-94 Parramatta Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 107 0
Other Collaborative groups
Name [1] 107 0
AGITG
Address [1] 107 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
CAMPERDOWN NSW 1450
Country [1] 107 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 896 0
University of Sydney
Ethics committee address [1] 896 0
Ethics committee country [1] 896 0
Australia
Date submitted for ethics approval [1] 896 0
Approval date [1] 896 0
Ethics approval number [1] 896 0
11-2004/5/7779
Ethics committee name [2] 897 0
Prince of Wales Hospital
Ethics committee address [2] 897 0
Ethics committee country [2] 897 0
Australia
Date submitted for ethics approval [2] 897 0
Approval date [2] 897 0
Ethics approval number [2] 897 0
Ethics committee name [3] 898 0
Border Medical Oncology
Ethics committee address [3] 898 0
Ethics committee country [3] 898 0
Australia
Date submitted for ethics approval [3] 898 0
Approval date [3] 898 0
Ethics approval number [3] 898 0
Ethics committee name [4] 899 0
St. George Hospital
Ethics committee address [4] 899 0
Ethics committee country [4] 899 0
Australia
Date submitted for ethics approval [4] 899 0
Approval date [4] 899 0
Ethics approval number [4] 899 0
Ethics committee name [5] 900 0
Newcastle Mater
Ethics committee address [5] 900 0
Ethics committee country [5] 900 0
Australia
Date submitted for ethics approval [5] 900 0
Approval date [5] 900 0
Ethics approval number [5] 900 0
Ethics committee name [6] 901 0
Alfred Hospital
Ethics committee address [6] 901 0
Ethics committee country [6] 901 0
Australia
Date submitted for ethics approval [6] 901 0
Approval date [6] 901 0
Ethics approval number [6] 901 0
Ethics committee name [7] 902 0
Nepean Hospital
Ethics committee address [7] 902 0
Ethics committee country [7] 902 0
Australia
Date submitted for ethics approval [7] 902 0
Approval date [7] 902 0
Ethics approval number [7] 902 0
Ethics committee name [8] 903 0
Royal Adelaide Hospital
Ethics committee address [8] 903 0
Ethics committee country [8] 903 0
Australia
Date submitted for ethics approval [8] 903 0
Approval date [8] 903 0
Ethics approval number [8] 903 0

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

Contacts
Principal investigator
Name 35938 0
Address 35938 0
Country 35938 0
Phone 35938 0
Fax 35938 0
Email 35938 0
Contact person for public queries
Name 9225 0
Dr David Goldstein
Address 9225 0
Department of Medical Oncology
Prince of Wales Hospital
High Street
Randwick NSW 2031
Country 9225 0
Australia
Phone 9225 0
+61 2 93822577
Fax 9225 0
+61 2 93822578
Email 9225 0
D.Goldstein@unsw.edu.au
Contact person for scientific queries
Name 153 0
Dr David Goldstein
Address 153 0
Department of Medical Oncology
Prince of Wales Hospital
High Street
Randwick NSW 2031
Country 153 0
Australia
Phone 153 0
+61 2 93822577
Fax 153 0
+61 2 93822578
Email 153 0
D.Goldstein@unsw.edu.au

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.