CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 178 enrolled
Drug / intervention
Preoperative radiotherapyradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01216202
NCT01216202N/ACompleted

Sexual Function and Wellbeing in Males Diagnosed With Rectal Cancer

Karolinska Institutet·observational·Posted Oct 7, 2010·Updated Oct 4, 2023

In Brief

An observational study evaluating Preoperative radiotherapy for Rectal Cancer. Completed, enrolled 178 participants across 2 sites.

Detailed Summary

Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. For men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where measurements of androgen hormone levels, semen samples and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesSweden

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2010
Enrollment StartApr 1, 2010
Primary CompletionMay 1, 2014
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.7 years ago

Interventions

Preoperative radiotherapyradiation

Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference. Testicular doses (TDs) was calculated from planning CT-scans and reported as mean cumulative testicular dose. Relative TD was calculated based in the assumption that RT regimens for rectal cancer are bioequivalent and referred to as proportion of prescribed dose absorbed by the testes.