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Shared Decision Making With Anal Cancer Patients on Radiation Dose (PC-Anal-01)

V

Vejle Hospital

Status

Active, not recruiting

Conditions

Anal Cancer

Treatments

Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.
Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.

Study type

Interventional

Funder types

Other

Identifiers

NCT02785263
PC-Anal-01

Details and patient eligibility

About

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.

Full description

The study will also provide new knowledge on the effect and side effects of irradiation of anal cancer, and detailed data from the dose planning will be instrumental in optimizing future decision aids.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 3 patient groups

Standard radiotherapy
Other group
Description:
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
Treatment:
Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
High dose radiotherapy
Other group
Description:
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
Treatment:
Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
Low dose radiotherapy
Other group
Description:
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
Treatment:
Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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