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Trial registered on ANZCTR


Registration number
ACTRN12612001242819
Ethics application status
Approved
Date submitted
9/11/2012
Date registered
23/11/2012
Date last updated
30/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vaginal Effects after Radiation Therapy in Anal Cancer Study
Scientific title
Vaginal Effects after Radiation Therapy in Anal Cancer Study
Secondary ID [1] 281407 0
Nil
Universal Trial Number (UTN)
U1111-1135-9316
Trial acronym
VERITAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal Cancer 287652 0
Condition category
Condition code
Cancer 287988 287988 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo standard chemoradiation over 6 weeks. They will receive education by verbal counselling and written information regarding the side effects of pelvic radiotherapy and vaginal dilator use. This will be a one-on-one session taking approximately 30 minutes, performed by qualified nursing staff. This will be conducted in the last week of chemoradiation (i.e. week 6) and repeated at the 3-month review.

Participants will be followed up at 4 weeks; and 3, 6, 9, 12, 18, 24 and 36 months after treatment. At each review session, compliance with vaginal dilator use, vaginal examinations for toxicity scoring, and quality of life questionnaires will be completed and documented.

Standard education will comprise of verbal and written information regarding the side effects of pelvic radiation. Permission for sexual intercourse is given to participants and frequency is documented.

Standard recommendation for vaginal dilator use: initiate vaginal dilator insertion within 6 weeks of completing chemoradiation, insert 3 times per week for 5 minutes duration, as tolerated.

Radiotherapy Schedule
Standard chemoradiation to 54 Gy in 30 fractions, 5 fractions per week using a three phase 3D-conformal technique.

From 2011, all participants except staged T1N0M0 are treated with a two-phase IMRT technique using simultaneous integrated boost.

Chemotherapy Schedule
Standard concurrent chemotherapy consists of infusional 5FU in week 1 and 5, with MMC on day 1. Some participants will receive PVI 5FU for 96 hours each week.

Vaginal Dilator
Vaginal dilators are smooth rigid cylinder-shaped pieces of plastic made of Delrin (Registered Trademark) acetal homopolymer.

Vaginal Dilator Therapy
Vaginal dilators are used with lubricant or oestrogen cream. Standard recommendation for vaginal dilator use: initiate vaginal dilator insertion within 6 weeks of completing chemoradiation, insert 3 times per week for 5 minutes duration, as tolerated. Permission for sexual intercourse up to 3 times per week is given to all participants.
Intervention code [1] 285897 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288199 0
Overall compliance: Adherence to the recommended dilator regimen (Yes or No) as defined by satisfying any three of the following four criteria:
Commence dilator use within 6 weeks of completing chemoradiation
A combined average frequency of dilator use and/or sexual intercourse of at least 3 times per week
An average insertion duration of at least 5 minutes
A duration of use of at least 12 months
Timepoint [1] 288199 0
Information regarding the following individual components of dilator use and sexual intercourse will be collected at baseline and at each of the follow-up reviews in order to determine the primary endpoint of overall compliance:

Time between completion of chemoradiation to initiation of dilator use (days/weeks) (<4 weeks, 4-6 weeks, 6-12 weeks, >12 weeks)
Average frequency of use (times per week) (<2, 2-3, >3 times per week)
Average duration of insertion (minutes) (<5, 5-10, >10 minutes)
Duration of dilator use (weeks/months/years) (6 weeks, 3, 6, 9, 12 months, 1-3 years, indefinitely)
Average frequency of sexual intercourse (times per week)
Secondary outcome [1] 299593 0
Incidence of stenosis as defined by grade 3+ vaginal stricture (per CTCAE version 4.03)
Timepoint [1] 299593 0
Time from date of registration until onset of stenosis (in weeks) where the date of onset of stenosis is defined to be the date of the earliest review where grade 3+ vaginal stricture is reported.
Assessed at 4 weeks, 3,6,9,12,18,24 and 36 months post-treatment.

Eligibility
Key inclusion criteria
Age 18 years or older.
Has provided written informed consent for participation in this trial.
Histological or cytologically confirmed anal cancer (all histological types).
Non-distant metastatic anal cancer.
ECOG performance status score of 2 or less.
Suitable for radical pelvic radiotherapy plus or minus concurrent chemotherapy.
Available for follow up.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Intended to received less than 45 Gy to pelvis i.e. not radical dose.
Participants who had or will require abdominoperineal resection due to changes in vaginal anatomy.
Significant psychiatric condition receiving active management which interferes with ability to comply with vaginal dilator use due to psychological reasons.

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)
Nurse coordinators, radiotherapy nursing staff, or treating radiation oncologists, medical oncologists or surgeons will identify eligible patients according to the inclusion and exclusion criteria. Eligible patients will be approached and written consent obtained. The trial site research coordinator, nurse coordinators or radiotherapy nursing staff will be notified.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single institution (including satellites) prospective single arm study
Phase
Not Applicable
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)
VIC
Recruitment hospital [1] 6768 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 5879 0
3128
Recruitment postcode(s) [2] 5880 0
3550
Recruitment postcode(s) [3] 5881 0
3165
Recruitment postcode(s) [4] 14413 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 286168 0
Hospital
Name [1] 286168 0
Peter MacCallum Cancer Centre
Address [1] 286168 0
305 Grattan St
Melbourne 3000
Country [1] 286168 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St
Melbourne 3000
Country
Australia
Secondary sponsor category [1] 285007 0
Individual
Name [1] 285007 0
Dr Jennifer Tan
Address [1] 285007 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne 3000
Country [1] 285007 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288235 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 288235 0
305 Grattan St
Melbourne 3000
Ethics committee country [1] 288235 0
Australia
Date submitted for ethics approval [1] 288235 0
01/07/2012
Approval date [1] 288235 0
07/08/2012
Ethics approval number [1] 288235 0
Peter Mac 12/43, AU RED HREC Ref no HREC/12/PMCC/20

Summary
Brief summary
This is a prospective single arm study.

Hypothesis
Primary hypothesis is that patients are able to comply with the use of vaginal dilators after radical chemoradiation for anal cancer.
Secondary hypotheses include that the use of vaginal dilators reduces grade 3-4 vaginal toxicity (stenosis), and therefore improves vaginal health, sexual function and quality of life.

Inclusion Criteria
Inclusion criteria are age greater than 18 years, female, histologically-proven non distant metastatic anal cancer (squamous cell carcinoma or adenocarcinoma), suitable for treatment with radical pelvic radiotherapy to greater than 45 Gray with or without concurrent chemotherapy (Mitomycin C (MMC) and/or 5-Fluorouracil (5FU).

Exclusion Criteria
Participants with pre-existing psychiatric illness or who had abdominoperineal resection are excluded.

Radiation Therapy Treatment
The standard regimen consist of external beam radiotherapy to a total dose of 50.4 to 54Gy using a three-phase technique. From 2011, some participants are treated with a two-phase Intensity Modulated Radiotherapy Technique (IMRT).

Chemotherapy Treatment
Standard concurrent chemotherapy consists of infusional 5FU 1g/m2 for 4 days in week 1 and 5, with MMC 10mg/m2 on day 1. Some participants will receive protracted infusional 5FU (PVI 5FU) 300mg/m2 for 96 hours each week.
Device
Vaginal dilators are smooth rigid cylinder-shaped pieces of plastic. There are four standard sizes of varying diameters. They are used with a lubricant or oestrogen cream. Standard recommendation for their use: initiate insertion within 6 weeks of completing chemoradiation; insert 3 times per week for 5 minutes duration.

Follow-up Schedule
At the completion of chemoradiation, participants will be reviewed at 4 weeks; and 3, 6, 9, 12, 18, 24 and 36 months.

Sample Size and Duration
A pragmatic sample size of forty participants will be accrued for this trial. The anticipated duration to complete accrual is 30 months. Participants will undergo 6 weeks of chemoradiation and then 3 years follow up. The total study duration is therefore expected to be 68 months. A planned interim analysis will take place after 15 participants have completed 12 months follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34844 0
Dr Jennifer Tan
Address 34844 0
Peter MacCallum Cancer Centre
305 Grattan St.
Melbourne 3000
Country 34844 0
Australia
Phone 34844 0
+61 3 85595000
Fax 34844 0
Email 34844 0
jennifer.tan@petermac.org
Contact person for public queries
Name 18091 0
Ms Lisa Selbie
Address 18091 0
Peter MacCallum Cancer Centre
305 Grattan St.
Melbourne 3000
Country 18091 0
Australia
Phone 18091 0
+61 3 85597388
Fax 18091 0
+61 3 8559 7439
Email 18091 0
lisa.selbie@petermac.org
Contact person for scientific queries
Name 9019 0
Dr Dr Jennifer Tan
Address 9019 0
Peter MacCallum Cancer Centre
305 Grattan St.
Melbourne 3000
Country 9019 0
Australia
Phone 9019 0
+61 3 85595000
Fax 9019 0
+61 3 8559 7719
Email 9019 0
jennifer.tan@petermac.org

No information has been provided regarding IPD availability
Summary results
No Results