Bone-sparing Chemoradiotherapy for Anal Cancer – DACG-II

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Brief Title

Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

Official Title

Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial. Danish Anal Cancer Group Study

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.
    


Study Type

Interventional


Primary Outcome

Rate of PIFs

Secondary Outcome

 Rate of symptomatic PIFs

Condition

Anal Cancer

Intervention

Bone sparring radiotherapy

Study Arms / Comparison Groups

 Bone sparring radiotherapy
Description:  Observational arm of bone-sparing radiotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

August 23, 2021

Completion Date

March 1, 2026

Primary Completion Date

March 1, 2024

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karen-Lise G Spindler, DMSc, PhD, +4591167244, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT05385250

Organization ID

DACG-II


Responsible Party

Sponsor-Investigator

Study Sponsor

Karen-Lise Garm Spindler

Collaborators

 Herlev Hospital

Study Sponsor

Karen-Lise G Spindler, DMSc, PhD, Study Chair, Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG


Verification Date

May 2022