Anal CancerPC-Anal-01NCT02785263
Shared Decision Making With Anal Cancer Patients on Radiation Dose
A study testing 2.15 gray and 1.8 gray. Max. 6 weeks. and 2.15 gray and 1.8 gray. Max. 5 weeks. in people with Anal Cancer, run by Vejle Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- 2.15 gray and 1.8 gray. Max. 6 weeks. and 2.15 gray and 1.8 gray. Max. 5 weeks.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
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.
Read the 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.
- Conditions
- Anal Cancer
- Being tested
- 2.15 gray and 1.8 gray. Max. 6 weeks., 2.15 gray and 1.8 gray. Max. 5 weeks.
- Keywords
- Anal cancer, Shared decision making
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.15 gray and 1.8 gray. Max. 6 weeks.Radiation
2.15 gray and 1.8 gray. Max. 5 weeks.Radiation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fraction of enrolled patients wanting to take part in the decision making on radiation dose level
Measured: 6 months after the last patient has finished radiotherapy
The fraction of enrolled patients choosing the lower radiation dose
Measured: 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
Measured: 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
Measured: 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)
Measured: 5 years after inclusion of the last patient
Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29
Measured: 5 years after inclusion of the last patient
Subjective symptoms as assessed by LARS score (low anterior resection syndrome)
Measured: 5 years after inclusion of the last patient
Rate of complete response
Measured: 6 months after the last patient has finished radiotherapy
Number of patients with loco-regional recurrence 60 months after end of treatment
Measured: 5 years after inclusion of the last patient
Number of patients with distant metastases at 5 years
Measured: 5 years after inclusion of the last patient
Colostomy free survival
Measured: 5 years after inclusion of the last patient
Disease free survival
Measured: 5 years after inclusion of the last patient
Overall survival
Measured: 5 years after inclusion of the last patient
Number of patients with HPV at time of enrollment
Measured: 6 months after the last patient has finished radiotherapy
Response evaluation assessed by diffusion weighted imaging
Measured: 6 months after the last patient has finished radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2021
- Study completionJun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars H Jensen, MD,PhD, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785263
- Sponsor's protocol ID
- PC-Anal-01
- Acronym
- PC-Anal-01
- Status last verified
- Jul 2025
- First submitted
- 9 May 2016
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
- ClinicalTrials.gov ID
- NCT02785263
- Acronym / sponsor ID
- PC-Anal-01 / PC-Anal-01
- Conditions
- Anal Cancer
- Keywords
- Anal cancer, Shared decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard radiotherapy | Other | Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.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 |
| High dose radiotherapy | Other | Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.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 |
| Low dose radiotherapy | Other | Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2.15 gray and 1.8 gray. Max. 6 weeks. | Radiation | High dose radiotherapy, Standard radiotherapy |
| 2.15 gray and 1.8 gray. Max. 5 weeks. | Radiation | Low dose radiotherapy |
Primary outcome
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
The fraction of enrolled patients choosing the lower radiation dose
Time frame: 6 months after the last patient has finished radiotherapy
13 secondary outcomes
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
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
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
Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29
Time frame: 5 years after inclusion of the last patient
Subjective symptoms as assessed by LARS score (low anterior resection syndrome)
Time frame: 5 years after inclusion of the last patient
Rate of complete response
Time frame: 6 months after the last patient has finished radiotherapy
Number of patients with loco-regional recurrence 60 months after end of treatment
Time frame: 5 years after inclusion of the last patient
Number of patients with distant metastases at 5 years
Time frame: 5 years after inclusion of the last patient
Colostomy free survival
Time frame: 5 years after inclusion of the last patient
Disease free survival
Time frame: 5 years after inclusion of the last patient
Overall survival
Time frame: 5 years after inclusion of the last patient
Number of patients with HPV at time of enrollment
Time frame: 6 months after the last patient has finished radiotherapy
Response evaluation assessed by diffusion weighted imaging
Time frame: 6 months after the last patient has finished radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars H Jensen, MD,PhD study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.15 gray and 1.8 gray. Max. 6 weeks. and 2.15 gray and 1.8 gray. Max. 5 weeks. in people with Anal Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.