Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05055635

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

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.

Recruiting

Interested in participating?

Request Info

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 Rectal Diseases Rectal Neoplasms Recurrent Anal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Danish Centre for Particle Therapy

Aarhus N, Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Camilla Kronborg, MD, PhD

CONTACT

[email protected]

+45 7845 0000

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pencil beam proton therapy

Radiation

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

Primary outcomes

  1. Local control

    Time frame: 12 months

    MRI

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Kronborg, MD, PhD

CONTACT

[email protected]

+45 78 45 00 00

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy

Acronym: ReRad III

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Sep 24, 2021
Registry last updated
Sep 24, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.