Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
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.
Conditions
This trial is treating people with Anal Cancer
Eligibility
Inclusion
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
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.
Inclusion
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Peter MacCallum Cancer Centre
Scientific Title
Vaginal Effects after Radiation Therapy in Anal Cancer Study (Other ID: U1111-1135-9316)
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