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Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) (ReRad III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05055635
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:
This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.

Condition or disease Intervention/treatment Phase
Anal Cancer Recurrent Anal Cancer Radiation: Pencil beam proton therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
Actual Study Start Date : July 7, 2021
Estimated Primary Completion Date : July 6, 2027
Estimated Study Completion Date : July 6, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Doseescalated pencil beam proton therapy
Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day.
 Radiation: Pencil beam proton therapy
Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day


Outcome Measures
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Primary Outcome Measures :
  1. Local control [ Time Frame: 12 months ]
    MRI


Secondary Outcome Measures :
  1. Local re-recurrence [ Time Frame: 6 and 24 months ]
  2. Progression free survival [ Time Frame: 3-5 year FU ]
  3. Overall survival [ Time Frame: 3-5 year FU ]
  4. Pathological evaluation of R0, R1 or R2 resection [ Time Frame: 6 months ]
  5. Toxicity [ Time Frame: up to 6 weeks, 1 year, 3 year ]
    evaluated by NCI-CTCAE v. 5.0

  6. Quality of life assessment [ Time Frame: up to 6 weeks, 1 year, 3 year ]
    EORTC QLQ-c30

  7. Quality of life assessment [ Time Frame: up to 6 weeks, 1 year, 3 year ]
    QLQ-CR29

  8. Quality of life assessment [ Time Frame: up to 6 weeks, 1 year, 3 year ]
    QLQ-ANL27

  9. Quality of life assessment [ Time Frame: up to 6 weeks, 1 year, 3 year ]
    LARS score

  10. Translational research [ Time Frame: baseline, end of therapy, 1 year ]
    cfDNA

  11. Summed radiotherapy dose volume to organs at risk and correlation to toxicities [ Time Frame: up to 6 weeks, 1 year, 3 year ]
  12. To investigate 30-day surgical overall morbidity [ Time Frame: 30-day ]
    Clavien-Dindo

  13. To investigate 6-month surgical site morbidity [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent anal cancer
  • Bioptically verified (squamous cell carcinoma)
  • Available dose plan from primary radiotherapy
  • Previous RT (>30Gy EQD2)
  • Evaluated in MDT-conferences (Herlev, Aarhus)
  • Age>18 years
  • PS 0-2
  • Adequate organ function
  • Written informed consent

Exclusion Criteria:

  • Distant metastases deemed without curative intended treatment options (PET-CT)
  • Unable to undergo MRI, PET-CT
  • Inability to attend full course radiotherapy and follow up in the outpatient clinic.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05055635


Contacts
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Contact: Camilla Kronborg, MD, PhD +45 78 45 00 00 camkro@rm.dk

Locations
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Denmark
Danish Centre for Particle Therapy Recruiting
Aarhus N, Aarhus, Denmark, 8200
Contact: Camilla Kronborg, MD, PhD    +45 7845 0000    camkro@rm.dk   
Sponsors and Collaborators
University of Aarhus
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT05055635    
Other Study ID Numbers: DCPT070721
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anus Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases