Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II (DACG-II)
August 13, 2024 updated by: Karen-Lise Garm Spindler
Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial Danish Anal Cancer Group Study
This study proposal includes a prospective clinical trial of bone sparing treatment planning in anal cancer patients.
the trial aim to lower the risk of bone damage, while adhering with the constrains to the bowel, bladder and other conventional Organs At Risk, and finally to describe the fraction of pelvic insufficiency fractures in patients treated with optimized radiotherapy.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients will receive standard (chemo)-radiotherapy according to national Danish Anal Cancer Group (DACG) guidelines, but the bone-sparing focus will be added to the algorithm for dose-constrains and planning objectives.
A bone specific magnetic resonance scan will be performed at 1 year post treatment.
Additional substudies include collection of blood samples for translational research purposes.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with biopsy verified localized squamous cell anal cancer
- Indication for standard (chemo)-radiotherapy with curative intend for anal cancer as per multidisciplinary team decision
- Clinical eligible for standard (chemo)-radiotherapy as per physicians' decision
- Written and oral consent
- Age at least 18 years
Exclusion Criteria:
- Previous pelvic radiotherapy
- Previous systemic therapy with severe bone marrow suppression or hematological diseases
- Hip-replacements
- Contraindications to MRI-scan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Bone sparring radiotherapy
Observational arm of bone-sparing radiotherapy
|
Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of PIFs
Time Frame: 1 year
|
Rate of pelvic insufficience fractures (PIF) on MRI
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of symptomatic PIFs
Time Frame: after 1 and 3 year
|
Rate of symptomatic Pelvic insufficiency fractures (PIF)
|
after 1 and 3 year
|
|
Rate of toxicity from standard organs at risk (OAR)
Time Frame: after 1 and 3 years
|
Rate of physician rated toxicity from standard OAR; bowel, bladder, skin
|
after 1 and 3 years
|
|
Patient reported outcome measures (FACT-BP)
Time Frame: Pretreatment and after 1 and 3 years
|
Patient reported outcome measures by Functional Assessment of Cancer Therapy - Bone Pain score
|
Pretreatment and after 1 and 3 years
|
|
Quality of Life measures (EORTC)
Time Frame: Pretreatment and after 1 and 3 years
|
Quality of Life measures (EORTC)
|
Pretreatment and after 1 and 3 years
|
|
Predictive and prognostic biomarkers
Time Frame: Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years
|
Prognostic value of levels of circulating DNA (copies per ML) in blood samples
|
Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years
|
|
Patient reported outcomes measures (LARS)
Time Frame: Pretreatment and at 1 and 3 years
|
Patient reported outcome measure by LARS (low anterior resection syndrome) scores 1-5
|
Pretreatment and at 1 and 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Karen-Lise G Spindler, DMSc, PhD, Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2021
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
May 18, 2022
First Posted (Actual)
May 23, 2022
Study Record Updates
Last Update Posted (Actual)
August 15, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DACG-II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.