NCT02785263

Brief Summary

The purpose of this study is to maximize patient involvement in the treatment of anal cancer. Specifically, the investigators will investigate whether patients wish to take part in the decision making on radiation dose and whether they want a high or low radiation dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

May 9, 2016

Last Update Submit

July 7, 2025

Conditions

Anal Cancer

Keywords

Anal cancerShared decision making

Outcome Measures

Primary Outcomes (2)

  • The fraction of enrolled patients wanting to take part in the decision making on radiation dose level

    6 months after the last patient has finished radiotherapy

  • The fraction of enrolled patients choosing the lower radiation dose

    6 months after the last patient has finished radiotherapy

Secondary Outcomes (13)

  • Number of patients with a V45Gy of less than 300 cc for the small bowel calculated on the basis of dose plans

    6 months after the last patient has finished radiotherapy

  • Number of patients with a V35Gy of less than 75% for the bladder calculated on the basis of dose plans

    6 months after the last patient has finished radiotherapy

  • Number of patients with treatment related adverse events as assessed by healthcare staff based on the common toxicity criteria (CTCAE v.4.0)

    5 years after inclusion of the last patient

  • Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29

    5 years after inclusion of the last patient

  • Subjective symptoms as assessed by LARS score (low anterior resection syndrome)

    5 years after inclusion of the last patient

  • +8 more secondary outcomes

Study Arms (3)

Standard radiotherapy

OTHER

Daily on weekdays: 2.15 gray for tumor and verified lymph node metastases and 1.8 gray for the elective volume. A total of 28 treatments

Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.

High dose radiotherapy

OTHER

Daily on weekdays: 2.15 gray for tumor and verified lymph node metastases and 1.8 gray for the elective volume. A total of 28 treatments

Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.

Low dose radiotherapy

OTHER

Daily on weekdays: 2.15 gray for tumor and verified lymph node metastases and 1.8 gray for the elective volume. A total of 25 treatments

Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.

Interventions

2.15 gray and 1.8 gray. Max. 6 weeks.RADIATION
High dose radiotherapyStandard radiotherapy
2.15 gray and 1.8 gray. Max. 5 weeks.RADIATION
Low dose radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Squamous cell carcinoma of the anal duct or perianal (non-hairy skin, max 5 cm from the anal verge)
  • T2-T4 N0-3
  • Age ≥ 18 years
  • Performance status 0-2
  • Sufficient organ and bone marrow function defined as:
  • Neutrophils ≥ 1.5 x 10\^9/L
  • Thrombocytes ≥ 100 x 10\^9/L
  • Curative intent radiation treatment deemed possible
  • Patients chooses 1 of 3 options:
  • I do not wish to decide on details of my treatment, but I would like to receive the standard treatment
  • I want to receive the high radiation dose
  • I want to receive the low radiation dose
  • Written and orally informed consent

You may not qualify if:

  • Non-resectable metastases
  • Tumor \> 10 cm or the total tumor volume (incl. lymph node metastases) is too large to be included in an appropriate radiation field (after possible neoadjuvant chemotherapy)
  • Pregnant or breastfeeding women
  • Fertile women not willing to use effective contraception
  • Serious co-morbidity that would hinder interfere with radiation treatment or hinder patient compliance (e.g. incapacity to understand or complete questionnaires)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Lars H Jensen, MD,PhD

    Vejle Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 27, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

DK(1)