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Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II (DACG-II)

Primary Purpose

Anal Cancer, Radiotherapy Side Effect

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bone sparring radiotherapy
Sponsored by
Karen-Lise Garm Spindler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bone sparring radiotherapy

Arm Description

Observational arm of bone-sparing radiotherapy

Outcomes

Primary Outcome Measures

Rate of PIFs
Rate of pelvic insufficience fractures (PIF) on MRI

Secondary Outcome Measures

Rate of symptomatic PIFs
Rate of symptomatic Pelvic insufficiency fractures (PIF)
Rate of toxicity from standard organs at risk (OAR)
Rate of physician rated toxicity from standard OAR; bowel, bladder, skin
Predictive and prognostic biomarkers
Correlation between levels of circulating DNA (copies per ML) in blood samples and outcomes
Patient reported outcomes measures (LARS)
Patient reported outcome measure by LARS (low anterior resection syndrome) scores
Patient reported outcome measures (FACT-BP)
Patient reported outcome measures by Functional Assessment of Cancer Therapy - Bone Pain score
Quality of Life measures (EORTC)
Quality of Life measures (EORTC)

Full Information

First Posted
February 24, 2022
Last Updated
May 18, 2022
Sponsor
Karen-Lise Garm Spindler
Collaborators
Herlev Hospital, Zealand University Hospital, Vejle Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05385250
Brief Title
Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II
Acronym
DACG-II
Official Title
Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial. Danish Anal Cancer Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen-Lise Garm Spindler
Collaborators
Herlev Hospital, Zealand University Hospital, Vejle Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study proposal includes a prospective clinical trial of bone sparing treatment planning in anal cancer patients. We seek 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, Radiotherapy Side Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A phase II prospective observational clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone sparring radiotherapy
Arm Type
Other
Arm Description
Observational arm of bone-sparing radiotherapy
Intervention Type
Other
Intervention Name(s)
Bone sparring radiotherapy
Intervention Description
Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer
Primary Outcome Measure Information:
Title
Rate of PIFs
Description
Rate of pelvic insufficience fractures (PIF) on MRI
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of symptomatic PIFs
Description
Rate of symptomatic Pelvic insufficiency fractures (PIF)
Time Frame
after 1 and 3 year
Title
Rate of toxicity from standard organs at risk (OAR)
Description
Rate of physician rated toxicity from standard OAR; bowel, bladder, skin
Time Frame
after 1 and 3 years
Title
Predictive and prognostic biomarkers
Description
Correlation between levels of circulating DNA (copies per ML) in blood samples and outcomes
Time Frame
Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years
Title
Patient reported outcomes measures (LARS)
Description
Patient reported outcome measure by LARS (low anterior resection syndrome) scores
Time Frame
Pretreatment and after 1 and 3 years
Title
Patient reported outcome measures (FACT-BP)
Description
Patient reported outcome measures by Functional Assessment of Cancer Therapy - Bone Pain score
Time Frame
Pretreatment and after 1 and 3 years
Title
Quality of Life measures (EORTC)
Description
Quality of Life measures (EORTC)
Time Frame
Pretreatment and after 1 and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garm Spindler, Professor
Phone
+4591167244
Email
k.g.spindler@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen-Lise G Spindler, DMSc, PhD
Organizational Affiliation
Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

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