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

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ClinicalTrials.gov Identifier: NCT02785263
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

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.

Condition or disease Intervention/treatment Phase
Anal Cancer Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks. Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks. Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
Actual Study Start Date : June 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arm Intervention/treatment
Standard radiotherapy
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
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
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.



Primary Outcome Measures :
  1. 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 ]
  2. The fraction of enrolled patients choosing the lower radiation dose [ Time Frame: 6 months after the last patient has finished radiotherapy ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29 [ Time Frame: 5 years after inclusion of the last patient ]
  5. Subjective symptoms as assessed by LARS score (low anterior resection syndrome) [ Time Frame: 5 years after inclusion of the last patient ]
  6. Rate of complete response [ Time Frame: 6 months after the last patient has finished radiotherapy ]
  7. Number of patients with loco-regional recurrence 60 months after end of treatment [ Time Frame: 5 years after inclusion of the last patient ]
  8. Number of patients with distant metastases at 5 years [ Time Frame: 5 years after inclusion of the last patient ]
  9. Colostomy free survival [ Time Frame: 5 years after inclusion of the last patient ]
  10. Disease free survival [ Time Frame: 5 years after inclusion of the last patient ]
  11. Overall survival [ Time Frame: 5 years after inclusion of the last patient ]
  12. Number of patients with HPV at time of enrollment [ Time Frame: 6 months after the last patient has finished radiotherapy ]
  13. Response evaluation assessed by diffusion weighted imaging [ Time Frame: 6 months after the last patient has finished radiotherapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785263


Contacts
Contact: Lars H Jensen, MD, PhD lars.henrik.jensen@rsyd.dk

Locations
Denmark
Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Lars H Henriksen, MD, PhD       lars.henrik.jensen@rsyd.dk   
Principal Investigator: Lars H Jensen, MD, PhD         
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Lars H Jensen, MD,PhD Vejle Hospital

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT02785263     History of Changes
Other Study ID Numbers: PC-Anal-01
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Vejle Hospital:
Anal cancer
Shared decision making

Additional relevant MeSH terms:
Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases