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

Phase 2

Recruiting

• Conditions: Anal Cancer; Recurrent Anal Cancer
• Interventions: Radiation: Pencil beam proton therapy

• Registration Number: NCT05055635
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24
• Primary Completion: 2027-07-06
• Study Completion: 2030-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doseescalated pencil beam proton therapy	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.

Primary Outcome Measures

Name	Time	Method
Local control	12 months	MRI

Secondary Outcome Measures

Name	Time	Method
Local re-recurrence	6 and 24 months
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	30-day	Clavien-Dindo
Translational research	baseline, end of therapy, 1 year	cfDNA
Toxicity	up to 6 weeks, 1 year, 3 year	evaluated by NCI-CTCAE v. 5.0
Quality of life assessment	up to 6 weeks, 1 year, 3 year	LARS score
Progression free survival	3-5 year FU
Overall survival	3-5 year FU
Pathological evaluation of R0, R1 or R2 resection	6 months
To investigate 6-month surgical site morbidity	6 months

Trial Locations

Locations (1)

Danish Centre for Particle Therapy; 🇩🇰 Aarhus N, Aarhus, Denmark