Anal CancerDACG-IINCT05385250
Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II
A study testing Bone sparring radiotherapy in people with Anal Cancer and Radiotherapy Side Effect, run by Karen-Lise Garm Spindler at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Radiotherapy Side Effect
- What is being tested?
- Bone sparring radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Aug 2021to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous pelvic radiotherapy
- Previous systemic therapy with severe bone marrow suppression or hematological diseases
- Hip-replacements
- Contraindications to MRI-scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anal Cancer, Radiotherapy Side Effect
- Being tested
- Bone sparring radiotherapy
- Medical subject headings
- Anus Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone sparring radiotherapyOther
Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer
| Study group | Role | What they receive |
|---|---|---|
| Bone sparring radiotherapy | Other | Observational arm of bone-sparing radiotherapy Receives: Other: Bone sparring radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PIFs
Rate of pelvic insufficience fractures (PIF) on MRI
Measured: 1 year
Secondary outcomes (6)
Rate of symptomatic PIFs
Rate of symptomatic Pelvic insufficiency fractures (PIF)
Measured: after 1 and 3 year
Rate of toxicity from standard organs at risk (OAR)
Rate of physician rated toxicity from standard OAR; bowel, bladder, skin
Measured: after 1 and 3 years
Predictive and prognostic biomarkers
Prognostic value of levels of circulating DNA (copies per ML) in blood samples
Measured: Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years
Patient reported outcomes measures (LARS)
Patient reported outcome measure by LARS (low anterior resection syndrome) scores 1-5
Measured: Pretreatment and at 1 and 3 years
Patient reported outcome measures (FACT-BP)
Patient reported outcome measures by Functional Assessment of Cancer Therapy - Bone Pain score
Measured: Pretreatment and after 1 and 3 years
Quality of Life measures (EORTC)
Quality of Life measures (EORTC)
Measured: Pretreatment and after 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start23 Aug 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A phase II prospective observational clinical trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karen-Lise Garm Spindler
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Zealand University Hospital, Vejle Hospital
- Responsible party
- Sponsor-investigator, Karen-Lise Garm Spindler, Aarhus University Hospital
- Investigators
- Karen-Lise G Spindler, DMSc, PhD, Study chair, Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385250
- Sponsor's protocol ID
- DACG-II
- Acronym
- DACG-II
- Status last verified
- Aug 2024
- First submitted
- 24 Feb 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial Danish Anal Cancer Group Study
- ClinicalTrials.gov ID
- NCT05385250
- Acronym / sponsor ID
- DACG-II / DACG-II
- Conditions
- Anal Cancer, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karen-Lise Garm SpindlerUniversity, hospital or other
- Collaborators
- Herlev Hospital, Zealand University Hospital, Vejle Hospital
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A phase II prospective observational clinical trial
| Arm | Type | Receives |
|---|---|---|
| Bone sparring radiotherapy | Other | Other: Bone sparring radiotherapyObservational arm of bone-sparing radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Previous pelvic radiotherapy
- Previous systemic therapy with severe bone marrow suppression or hematological diseases
- Hip-replacements
- Contraindications to MRI-scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone sparring radiotherapyObservation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer | Other | Bone sparring radiotherapy |
Primary outcome
Rate of PIFs
Time frame: 1 year
Rate of pelvic insufficience fractures (PIF) on MRI
6 secondary outcomes
Rate of symptomatic PIFs
Time frame: after 1 and 3 year
Rate of toxicity from standard organs at risk (OAR)
Time frame: 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
Patient reported outcomes measures (LARS)
Time frame: Pretreatment and at 1 and 3 years
Patient reported outcome measures (FACT-BP)
Time frame: Pretreatment and after 1 and 3 years
Quality of Life measures (EORTC)
Time frame: Pretreatment and after 1 and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen-Lise G Spindler, DMSc, PhD study chair
Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone sparring radiotherapy in people with Anal Cancer and Radiotherapy Side Effect, run by Karen-Lise Garm Spindler at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PIFs (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.