Dataset Information

Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) - a prospective, randomized, 2-armed phase-II-trial.

ABSTRACT: BACKGROUND:The incidence of anal cancer is rising in the last decades and more women are affected than men. The prognosis after chemoradiation is very good with complete remission rates of 80-90%. Thus, reducing therapy-related toxicities and improving quality of life are of high importance. With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy), the incidence of acute and chronic gastrointestinal toxicities has already been reduced. However, especially in female anal cancer patients genital toxicities like vaginal fibrosis and stenosis are of great relevance, too. Up to now, there are no prospective data reporting incidence rates, techniques of prevention or impact on quality of life. The aim of the DILANA trial is to evaluate the incidence and grade of vaginal fibrosis, to optimize radiotherapy by reducing dose to the vaginal wall to minimize genital toxicities and improve quality of life of anal cancer patients. METHODS:The study is designed as a prospective, randomized, two-armed, open, single-center phase-II-trial. Sixty patients will be randomized into one of two arms, which differ only in the diameter of a tampon used during treatment. All patients will receive standard (chemo) radiation with a total dose of 45-50.4?Gy to the pelvic and inguinal nodes with a boost to the anal canal up to 54-60?Gy. The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12?months after (chemo) radiation depending on the extent of vaginal dilation. Secondary endpoints are toxicities according to the CTC AE version 5.0 criteria, assessment of clinical feasibility of daily use of a tampon, assessment of compliance for the use of a vaginal dilator and quality of life. DISCUSSION:Prospective studies are needed evaluating the incidence and grade of vaginal fibrosis after (chemo) radiation in female anal cancer patients. Furthermore, the assessment of techniques to reduce the incidence of vaginal fibrosis like intrafractional vaginal dilation as well as other radiotherapy-independent methods like using a vaginal dilator are essential. Additionally, implementation of a systematic assessment of vaginal stenosis is necessary to grant reproducibility and comparability of future data. TRIAL REGISTRATION:The trial is registered with clinicaltrials.gov (NCT04094454, 19.09.2019).

SUBMITTER: Arians N

PROVIDER: S-EPMC6974962 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) - a prospective, randomized, 2-armed phase-II-trial.

Arians Nathalie N Häfner Matthias M Krisam Johannes J Lang Kristin K Wark Antje A Koerber Stefan A SA Hommertgen Adriane A Debus Jürgen J

BMC cancer 20200121 1

<h4>Background</h4>The incidence of anal cancer is rising in the last decades and more women are affected than men. The prognosis after chemoradiation is very good with complete remission rates of 80-90%. Thus, reducing therapy-related toxicities and improving quality of life are of high importance. With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy), the incidence of acute and chronic gastrointestinal toxicities has already been reduced. However, esp ...[more]

PMID: 31964381

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Project description:ObjectiveTo propose a consensus for prevention of vaginal stenosis in patients submitted to pelvic radiotherapy.MethodIn this methodological study, Delphi technique was applied for content validation on vaginal stenosis prevention. Data regarding content validation were collected from 32 specialists practicing in the oncology profession. The content validity index of items in the consensus was calculated based on the evaluations by the specialists.ResultsIn the first round, of the 38 items evaluated, 29 items reached a Content Validity Index (CVI-I) greater than 80%, and 9 items had a CVI lower than 80%. Of the items that did not obtain agreement, 2 items were excluded, and 7 were reformulated and included in the second round. In the second round, all 7 items obtained a CVI-I greater than 80%. The final instrument consisted of 29 items validated in the first round, plus 7 items reformulated and consolidated in the second round. The judges agreed that it is the responsibility of the health professionals to consult the patients undergoing radiation therapy in the area of sexuality to patients. The radiation oncologist should be the first professional to address this issue and the nurse oncologist in the follow-up consultation should pass the guidelines to the patients as comprehensively as possible. Patients should be informed about vaginal dilation, regardless of whether they are sexually active or have a partner. They should also be informed of when they can resume sexual activity. The procedure of vaginal dilation should be individualized. The prescribed vaginal dilators should be used with a lubricant for a duration of at least 5-10 minutes, 2-3 times a week, as per the need of each patient (sexual activity and/or clinical follow-up) for an indefinite time. Patients should seek medical help in case they experience pain, discomfort, or bleeding during dilation.ConclusionThe Brazilian version of the consensus for vaginal stenosis prevention in patients submitted to pelvic radiotherapy was validated with 36 items in 7 categories related to Responsibility; Target population; Rationale; Vaginal dilator; Content instructions; Information provision; and Patient support. In Brazil, the educational practices on vaginal dilation for patients submitted to radiotherapy partly revealed similar difficulties as identified in other studies as well as countries with reference to specific guidelines for the start and duration of vaginal dilation. The final consensus developed in this study could strengthen the guidelines for education of patients in Brazil and provide a future scope to establish a single and safe guideline.

Project description:AimsNode-positive bladder cancer (NPBC) carries a poor prognosis and has traditionally been treated palliatively. However, surgical series suggest that a subset of NPBC patients can achieve long-term control after cystectomy and lymph node dissection. There is little published data regarding the use of radiotherapy to treat NPBC patients. This is in part due to concerns regarding the toxicity of whole-pelvis radiotherapy using conventional techniques. We hypothesised that, using intensity-modulated radiotherapy (IMRT), the pelvic nodes and bladder could be treated within a radical treatment volume with acceptable toxicity profiles.Materials and methodsThe Intensity-modulated Pelvic Node and Bladder Radiotherapy (IMPART) trial was a phase II single-centre prospective study designed to assess the feasibility of delivering IMRT to treat the bladder and pelvic nodes in patients with node-positive or high-risk node-negative bladder cancer (NNBC). The primary end point was meeting predetermined dose constraints. Secondary end points included acute and late toxicity, pelvic relapse-free survival and overall survival.ResultsIn total, 38 patients were recruited and treated between June 2009 and November 2012; 22/38 (58%) had NPBC; 31/38 (81.6%) received neoadjuvant chemotherapy; 18/38 (47%) received concurrent chemotherapy; 37/38 (97%) patients had radiotherapy planned as per protocol. Grade 3 gastrointestinal and genitourinary acute toxicity rates were 5.4 and 20.6%, respectively. At 1 year, the grade 3 late toxicity rate was 5%; 1-, 2- and 5-year pelvic relapse-free survival rates were 55, 37 and 26%, respectively. The median overall survival was 1.9 years (95% confidence interval 1.1-3.8) with 1-, 2- and 5-year overall survival rates of 68, 50 and 34%, respectively.ConclusionDelivering IMRT to the bladder and pelvic nodes in NPBC and high-risk NNBC is feasible, with low toxicity and low pelvic nodal recurrence rates. Long-term control seems to be achievable in a subset of patients. However, relapse patterns suggest that strategies targeting both local recurrence and the development of distant metastases are required to improve patient outcomes.

Dataset Information

Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) - a prospective, randomized, 2-armed phase-II-trial.

Publications

Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) - a prospective, randomized, 2-armed phase-II-trial.

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