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NCT Number: NCT04695782

Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

Study design:

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.

Recruiting

Interested in participating?

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Key information

Conditions

Rectal Cancer Recurrent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Danish Centre for Particle Therapy

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Camilla Kronborg, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Locally recurrent rectal cancer.
  • Bioptically verified (adenocarcinoma )
  • Available dose plan from primary radiotherapy
  • Previous pelvic RT (>30Gy EQD2)
  • Evaluated in MDT-conferences (Herlev, Aarhus)
  • Age>18 years
  • PS 0-2
  • Adequate organ function
  • Informed consent

Exclusion criteria

  • Non-resectable distant metastases (PET-CT)
  • Unable to undergo MRI, PET-CT
  • Inability to attend full course radiotherapy and follow up in the out patient clinic.

Treatment and study plan

Pencil beam proton radiotherapy

Radiation

Doseescalated pencil beam proton Therapy

Primary outcomes

  1. R0-resection

    Time frame: 5-6 years

    Neo-adjuvant treatment: Rate of pathological complete resection (R0)

  2. 1-year local control

    Time frame: 6-7 years

    Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.

Secondary outcomes

  1. Local recurrence

    Time frame: 6-8 years

    Local re-recurrence determined by imaging 6, 12 and 24 month post treatment

  2. Disease free survival

    Time frame: 10 years

    Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course

  3. Overall survival

    Time frame: 10 years

    Overall survival defined as time from first day of treatment to death from any cause

  4. Toxicity

    Time frame: 5-7 years

    Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic

  5. Patient reported outcomes

    Time frame: 5-7 year

    Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic

Study contacts

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

Camilla Kronborg, MD, PhD

CONTACT

[email protected]

+45 78450000

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: ReRad II

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Jan 5, 2021
Registry last updated
Jan 5, 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.

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