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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anal Cancer; Recurrent Anal Cancer
• Intervention / Treatment: Radiation: Pencil beam proton therapy

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Camilla Kronborg, MD, PhD; Phone Number: +45 78 45 00 00; Email: camkro@rm.dk

Study Locations

• Denmark
  • Aarhus
    • Aarhus N, Aarhus, Denmark, 8200
      • Recruiting
      • Danish Centre for Particle Therapy
      • Contact: Camilla Kronborg, MD, PhD; Phone Number: +45 7845 0000; Email: camkro@rm.dk

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doseescalated pencil beam proton therapy; 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.	Radiation: Pencil beam proton therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control	MRI	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local re-recurrence		6 and 24 months
Progression free survival		3-5 year FU
Overall survival		3-5 year FU
Pathological evaluation of R0, R1 or R2 resection		6 months
Toxicity	evaluated by NCI-CTCAE v. 5.0	up to 6 weeks, 1 year, 3 year
Quality of life assessment	EORTC QLQ-c30	up to 6 weeks, 1 year, 3 year
Quality of life assessment	QLQ-CR29	up to 6 weeks, 1 year, 3 year
Quality of life assessment	QLQ-ANL27	up to 6 weeks, 1 year, 3 year
Quality of life assessment	LARS score	up to 6 weeks, 1 year, 3 year
Translational research	cfDNA	baseline, end of therapy, 1 year
Summed radiotherapy dose volume to organs at risk and correlation to toxicities		up to 6 weeks, 1 year, 3 year
To investigate 30-day surgical overall morbidity	Clavien-Dindo	30-day
To investigate 6-month surgical site morbidity		6 months

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Anticipated): July 6, 2027
• Study Completion (Anticipated): July 6, 2030

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Recurrence; Anus Neoplasms
• Other Study ID Numbers: DCPT070721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No