None listed
Conditions
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.
Interventions
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
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.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed