Shared Decision Making With Anal Cancer Patients on Radiation Dose

Anal Cancer Clinical Trial

— PC-Anal-01  

Official title:

Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02785263
• Other study ID #: PC-Anal-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: June 2025
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

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

• 2.15 gray and 1.8 gray. Max. 5 weeks.

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The fraction of enrolled patients choosing the lower radiation dose		6 months after the last patient has finished radiotherapy
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29		5 years after inclusion of the last patient
Secondary	Subjective symptoms as assessed by LARS score (low anterior resection syndrome)		5 years after inclusion of the last patient
Secondary	Rate of complete response		6 months after the last patient has finished radiotherapy
Secondary	Number of patients with loco-regional recurrence 60 months after end of treatment		5 years after inclusion of the last patient
Secondary	Number of patients with distant metastases at 5 years		5 years after inclusion of the last patient
Secondary	Colostomy free survival		5 years after inclusion of the last patient
Secondary	Disease free survival		5 years after inclusion of the last patient
Secondary	Overall survival		5 years after inclusion of the last patient
Secondary	Number of patients with HPV at time of enrollment		6 months after the last patient has finished radiotherapy
Secondary	Response evaluation assessed by diffusion weighted imaging		6 months after the last patient has finished radiotherapy