Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy (ReRad II)

January 4, 2021 updated by: University of Aarhus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Camilla Kronborg, MD, PhD
  • Phone Number: +45 78450000
  • Email: camkro@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Danish Centre for Particle Therapy
        • Contact:
          • Camilla Kronborg, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily
Radiation: Pencil beam proton radiotherapy
Doseescalated pencil beam proton Therapy
Experimental: Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily
Radiation: Pencil beam proton radiotherapy
Doseescalated pencil beam proton Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0-resection
Time Frame: 5-6 years
Neo-adjuvant treatment: Rate of pathological complete resection (R0)
5-6 years
1-year local control
Time Frame: 6-7 years
Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.
6-7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence
Time Frame: 6-8 years
Local re-recurrence determined by imaging 6, 12 and 24 month post treatment
6-8 years
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
10 years
Overall survival
Time Frame: 10 years
Overall survival defined as time from first day of treatment to death from any cause
10 years
Toxicity
Time Frame: 5-7 years
Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic
5-7 years
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
5-7 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Anticipated)

October 31, 2025

Study Completion (Anticipated)

October 31, 2028

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCPT221020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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