Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000188033
Ethics application status
Approved
Date submitted
25/02/2010
Date registered
2/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
TROG 99.02 Concurent radiation and chemotherapy for the organ conserving treatment of early anal canal cancer
Scientific title
TROG 99.02 A prospective single arm non randomised study of concurrent radiation and chemotherapy for the organ conserving treatment of early anal canal cancer assessed by colostomy free survival and late toxicity.
Universal Trial Number (UTN)
Trial acronym
TROG 99.02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anal canal cancer 256883 0
Condition category
Condition code
Cancer 257032 257032 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
concurrent radiation and chemotherapy over a total of 7 weeks 3 days.

Radiation:50.4 Gy given in split course - initial phase 36 Gy in 18 fractions to primary +/- perirectal nodes followed after 2 week gap with 14.4 Gy in 8 fractions to primary alone.

Chemotherapy: 5FU 800mg/m2/day (maximum 1.5gm a day) given by intravenous infusion (IV) Days 1-4 and Days 43-46 and Mitomycin C 10mg/m2 (maximum 15mg) by intravenous (IV) bolus Day 1 only.
Intervention code [1] 256075 0
Treatment: Drugs
Intervention code [2] 256076 0
Treatment: Other
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257921 0
To test the hypothesis that this chemoradiation schedule can acheive a 5 year colostomy free survival in 85% of patients with less than 10% Grade 3 and 4 Radiation Therapy Oncology Group (RTOG) late toxicity.

Colostomy free survival is assessed by clinical assessment. Late toxicity is scored using the Radiation Therapy Oncology Group /European Organisation for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Scheme
Timepoint [1] 257921 0
Follow up schedule for clinical assessment is 1,2,3, 6 months after completion of treatment and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5.

Late toxicity is scored by physician scored toxicity forms at 6 months post completion of treatment and and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5
Secondary outcome [1] 263405 0
local control rate assessed clinically with inspection and digital rectal examination and with other investigations such as biopsy and radiological investigations if appropriate
Timepoint [1] 263405 0
Clinical follow up schedule is 1,2,3, 6 months after completion of treatment and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5.
Secondary outcome [2] 263406 0
relapse free and overall survival as assessed clinically and by radiological investigations if appropriate
Timepoint [2] 263406 0
Follow up schedule is 1,2,3, 6 months after completion of treatment and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5.
Secondary outcome [3] 263407 0
Acute toxicity.
Acute toxicity is scored using the Common Toxicity Criteria (CTC) version 2.0 of the Radiation Therapy Oncology Group (RTOG) and the European Organisation for Research and Treatment of Cancer (EORTC)
Timepoint [3] 263407 0
Follow up schedule is 1,2 and 3 months after completion of treatment.
Secondary outcome [4] 263408 0
pattern of relapse as assessed clinically and by radiological investigations if appropriate
Timepoint [4] 263408 0
Follow up schedule is 1,2,3, 6 months after completion of treatment and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5.

Eligibility
Key inclusion criteria
squamous cell cancer including basaloid variant
Stage T1 and T2 <4cm, N0 or N1, M0
Performance status WHO grade 0,1,2
adequate bone marrow, liver and renal function
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
anal tumours of other histology eg adenocarcinoma
anal margin tumours
patients presenting with recurrent disease after prior excision
history of ischaemic heart disease where 5FU considered a cardiac hazard
impaired control of anal shpincter
known immunosuppression eg HIV +ve or AIDS
pregnant or lactating women

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2522 0
New Zealand
State/province [1] 2522 0

Funding & Sponsors
Funding source category [1] 256574 0
Self funded/Unfunded
Name [1] 256574 0
Country [1] 256574 0
Primary sponsor type
Other Collaborative groups
Name
Trans-Tasman Radiation Oncology Group Inc (TROG)
Address
TROG Central Operations
Dept Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7,
Hunter Region Mail Centre
NSW 2310
Australia
Country
Australia
Secondary sponsor category [1] 255868 0
None
Name [1] 255868 0
Address [1] 255868 0
Country [1] 255868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258608 0
Auckland Ethics Committee now called Northern Ethics Committee
Ethics committee address [1] 258608 0
Private Bag 92-522
Wellesley St
Auckland, 1010, New Zealand
Ethics committee country [1] 258608 0
New Zealand
Date submitted for ethics approval [1] 258608 0
Approval date [1] 258608 0
Ethics approval number [1] 258608 0

Summary
Brief summary
Anal canal cancer is generally sensitive to both radiation and chemotherapy and these two treatments given together is now the "gold standard treatment for most early anal canal cancers. Our study was designed to see if we could maintain the generally good cure rates using less extensive and lower doses of radiation and chemotherapy than have been given in some centres. We also looked to see if the less intensive treatment would result in a lower risk of serious side effects for the patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30878 0
Address 30878 0
Country 30878 0
Phone 30878 0
Fax 30878 0
Email 30878 0
Contact person for public queries
Name 14125 0
John Matthews
Address 14125 0
Dept Radiation Oncology
Auckland City Hospital
Park Rd
Auckland 1010
Country 14125 0
New Zealand
Phone 14125 0
+6493797440
Fax 14125 0
Email 14125 0
[email protected]
Contact person for scientific queries
Name 5053 0
John Matthews
Address 5053 0
Dept Radiation Oncology
Auckland City Hospital
Park Rd
Auckland 1010
Country 5053 0
New Zealand
Phone 5053 0
+6493797440
Fax 5053 0
Email 5053 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.