VERITAS : Vaginal Effects after Radiation Therapy in Anal Cancer Study (Other ID: U1111-1135-9316)

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Radiotherapy<br/>TrialTypeRadiotherapy
Trial

UnknownPhase Unknown

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Radiotherapy | Bowel (colorectum)Anus

Trial Overview Read MoreRead more

This trial is looking at the effects of vaginal dilator use, following pelvic radiotherapy for anal cancer.
 

This trial is treating patients with Anal Cancer.

This is a radiotherapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Vaginal Effects after Radiation Therapy in Anal Cancer Study (Other ID: U1111-1135-9316)

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

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.

Recruiting Hospitals Read MoreRead more

Peter MacCallum Cancer Centre Bendigo
Bendigo
Ms Catherine Anderson
catherine.anderson@petermac.org
03 5454 9234

Peter MacCallum Cancer Centre
Box Hill
Ms Lisa Selbie
Lisa.Selbie@petermac.org
03 9895 7528

Peter MacCallum Cancer Centre
Moorabbin
Moorabbin Research
moorabbin.research@petermac.org
03 9928 8994

Not Recruiting Hospitals Read MoreRead more

Closed

Peter MacCallum Cancer Centre
Parkville
Ms Lisa Selbie
Lisa.Selbie@petermac.org
(03) 8559 7388

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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