Back to resultsShared Decision Making With Anal Cancer Patients on Radiation Dose (PC-Anal-01)
Primary Purpose
Anal Cancer
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
2.15 gray and 1.8 gray. Max. 6 weeks.
2.15 gray and 1.8 gray. Max. 5 weeks.
Sponsored by
About this trial
This is an interventional treatment trial for Anal Cancer focused on measuring Anal cancer, Shared decision making
Eligibility Criteria
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)
Sites / Locations
- Vejle Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Standard radiotherapy
High dose radiotherapy
Low dose radiotherapy
Arm 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
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
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
Outcomes
Primary Outcome Measures
The fraction of enrolled patients wanting to take part in the decision making on radiation dose level
The fraction of enrolled patients choosing the lower radiation dose
Secondary Outcome Measures
Number of patients with a V45Gy of less than 300 cc for the small bowel calculated on the basis of dose plans
Number of patients with a V35Gy of less than 75% for the bladder calculated on the basis of dose plans
Number of patients with treatment related adverse events as assessed by healthcare staff based on the common toxicity criteria (CTCAE v.4.0)
Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29
Subjective symptoms as assessed by LARS score (low anterior resection syndrome)
Rate of complete response
Number of patients with loco-regional recurrence 60 months after end of treatment
Number of patients with distant metastases at 5 years
Colostomy free survival
Disease free survival
Overall survival
Number of patients with HPV at time of enrollment
Response evaluation assessed by diffusion weighted imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02785263
Brief Title
Shared Decision Making With Anal Cancer Patients on Radiation Dose
Acronym
PC-Anal-01
Official Title
Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer
Keywords
Anal cancer, Shared decision making
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard radiotherapy
Arm Type
Other
Arm 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
Arm Title
High dose radiotherapy
Arm Type
Other
Arm 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
Arm Title
Low dose radiotherapy
Arm Type
Other
Arm 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
Intervention Type
Radiation
Intervention Name(s)
2.15 gray and 1.8 gray. Max. 6 weeks.
Intervention Type
Radiation
Intervention Name(s)
2.15 gray and 1.8 gray. Max. 5 weeks.
Primary Outcome Measure Information:
Title
The fraction of enrolled patients wanting to take part in the decision making on radiation dose level
Time Frame
6 months after the last patient has finished radiotherapy
Title
The fraction of enrolled patients choosing the lower radiation dose
Time Frame
6 months after the last patient has finished radiotherapy
Secondary Outcome Measure Information:
Title
Number of patients with a V45Gy of less than 300 cc for the small bowel calculated on the basis of dose plans
Time Frame
6 months after the last patient has finished radiotherapy
Title
Number of patients with a V35Gy of less than 75% for the bladder calculated on the basis of dose plans
Time Frame
6 months after the last patient has finished radiotherapy
Title
Number of patients with treatment related adverse events as assessed by healthcare staff based on the common toxicity criteria (CTCAE v.4.0)
Time Frame
5 years after inclusion of the last patient
Title
Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29
Time Frame
5 years after inclusion of the last patient
Title
Subjective symptoms as assessed by LARS score (low anterior resection syndrome)
Time Frame
5 years after inclusion of the last patient
Title
Rate of complete response
Time Frame
6 months after the last patient has finished radiotherapy
Title
Number of patients with loco-regional recurrence 60 months after end of treatment
Time Frame
5 years after inclusion of the last patient
Title
Number of patients with distant metastases at 5 years
Time Frame
5 years after inclusion of the last patient
Title
Colostomy free survival
Time Frame
5 years after inclusion of the last patient
Title
Disease free survival
Time Frame
5 years after inclusion of the last patient
Title
Overall survival
Time Frame
5 years after inclusion of the last patient
Title
Number of patients with HPV at time of enrollment
Time Frame
6 months after the last patient has finished radiotherapy
Title
Response evaluation assessed by diffusion weighted imaging
Time Frame
6 months after the last patient has finished radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars H Jensen, MD,PhD
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Shared Decision Making With Anal Cancer Patients on Radiation Dose
We'll reach out to this number within 24 hrs