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Active, Not Recruiting

NCT Number: NCT05385250

Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiotherapy Side Effect Rectal Diseases Rectal Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone sparring radiotherapy

Other

Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer

Primary outcomes

  1. Rate of PIFs

    Time frame: 1 year

    Rate of pelvic insufficience fractures (PIF) on MRI

Secondary outcomes

  1. Rate of symptomatic PIFs

    Time frame: after 1 and 3 year

    Rate of symptomatic Pelvic insufficiency fractures (PIF)

  2. 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

  3. 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

  4. 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

  5. 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

  6. Quality of Life measures (EORTC)

    Time frame: Pretreatment and after 1 and 3 years

    Quality of Life measures (EORTC)

Sponsors and collaborators

Lead sponsor

Karen-Lise Garm Spindler

Other

Collaborators

  • Herlev Hospital
  • Vejle Hospital
  • Zealand University Hospital

Registry information

Official study title

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

Acronym: DACG-II

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 23, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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