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

Primary Purpose

Rectal Cancer Recurrent

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Pencil beam proton radiotherapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer Recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Centre for Particle TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily

Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily

Arm Description

Outcomes

Primary Outcome Measures

R0-resection
Neo-adjuvant treatment: Rate of pathological complete resection (R0)
1-year local control
Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.

Secondary Outcome Measures

Local recurrence
Local re-recurrence determined by imaging 6, 12 and 24 month post treatment
Disease free survival
Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course
Overall survival
Overall survival defined as time from first day of treatment to death from any cause
Toxicity
Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic
Patient reported outcomes
Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic

Full Information

First Posted
January 4, 2021
Last Updated
January 4, 2021
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04695782
Brief Title
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Acronym
ReRad II
Official Title
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily
Arm Type
Experimental
Arm Title
Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Pencil beam proton radiotherapy
Intervention Description
Doseescalated pencil beam proton Therapy
Primary Outcome Measure Information:
Title
R0-resection
Description
Neo-adjuvant treatment: Rate of pathological complete resection (R0)
Time Frame
5-6 years
Title
1-year local control
Description
Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.
Time Frame
6-7 years
Secondary Outcome Measure Information:
Title
Local recurrence
Description
Local re-recurrence determined by imaging 6, 12 and 24 month post treatment
Time Frame
6-8 years
Title
Disease free survival
Description
Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course
Time Frame
10 years
Title
Overall survival
Description
Overall survival defined as time from first day of treatment to death from any cause
Time Frame
10 years
Title
Toxicity
Description
Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic
Time Frame
5-7 years
Title
Patient reported outcomes
Description
Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic
Time Frame
5-7 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Kronborg, MD, PhD
Phone
+45 78450000
Email
camkro@rm.dk
Facility Information:
Facility Name
Danish Centre for Particle Therapy
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Kronborg, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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