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Vaginal Effects after Radiation Therapy in Anal Cancer Study (Other ID: U1111-1135-9316)
Other Non-Commercial Sponsor
Peter MacCallum Cancer Centre
This is a prospective single arm study.
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 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).
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).
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.
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.
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.