Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) (ReRad III)
Primary Purpose
Anal Cancer, Recurrent Anal Cancer
Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Pencil beam proton therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anal Cancer
Eligibility 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.
Sites / Locations
- Danish Centre for Particle TherapyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Doseescalated pencil beam proton therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Local control
MRI
Secondary Outcome Measures
Local re-recurrence
Progression free survival
Overall survival
Pathological evaluation of R0, R1 or R2 resection
Toxicity
evaluated by NCI-CTCAE v. 5.0
Quality of life assessment
EORTC QLQ-c30
Quality of life assessment
QLQ-CR29
Quality of life assessment
QLQ-ANL27
Quality of life assessment
LARS score
Translational research
cfDNA
Summed radiotherapy dose volume to organs at risk and correlation to toxicities
To investigate 30-day surgical overall morbidity
Clavien-Dindo
To investigate 6-month surgical site morbidity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05055635
Brief Title
Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
Acronym
ReRad III
Official Title
ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
July 6, 2027 (Anticipated)
Study Completion Date
July 6, 2030 (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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, Recurrent Anal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Doseescalated pencil beam proton therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Pencil beam proton therapy
Intervention Description
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 Outcome Measure Information:
Title
Local control
Description
MRI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Local re-recurrence
Time Frame
6 and 24 months
Title
Progression free survival
Time Frame
3-5 year FU
Title
Overall survival
Time Frame
3-5 year FU
Title
Pathological evaluation of R0, R1 or R2 resection
Time Frame
6 months
Title
Toxicity
Description
evaluated by NCI-CTCAE v. 5.0
Time Frame
up to 6 weeks, 1 year, 3 year
Title
Quality of life assessment
Description
EORTC QLQ-c30
Time Frame
up to 6 weeks, 1 year, 3 year
Title
Quality of life assessment
Description
QLQ-CR29
Time Frame
up to 6 weeks, 1 year, 3 year
Title
Quality of life assessment
Description
QLQ-ANL27
Time Frame
up to 6 weeks, 1 year, 3 year
Title
Quality of life assessment
Description
LARS score
Time Frame
up to 6 weeks, 1 year, 3 year
Title
Translational research
Description
cfDNA
Time Frame
baseline, end of therapy, 1 year
Title
Summed radiotherapy dose volume to organs at risk and correlation to toxicities
Time Frame
up to 6 weeks, 1 year, 3 year
Title
To investigate 30-day surgical overall morbidity
Description
Clavien-Dindo
Time Frame
30-day
Title
To investigate 6-month surgical site morbidity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Kronborg, MD, PhD
Phone
+45 78 45 00 00
Email
camkro@rm.dk
Facility Information:
Facility Name
Danish Centre for Particle Therapy
City
Aarhus N
State/Province
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Kronborg, MD, PhD
Phone
+45 7845 0000
Email
camkro@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
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