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

Anal Cancer Clinical Trial

— ReRad III  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055635
• Other study ID #: DCPT070721
• Status: Recruiting
• Phase: Phase 2
• Start date: July 7, 2021
• Est. completion date: July 6, 2030

Study information

• Verified date: July 2021
• Source: University of Aarhus
• Contact: Camilla Kronborg, MD, PhD
• Phone: +45 78 45 00 00
• Email: camkro[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 6, 2030
• Est. primary completion date: July 6, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Recurrence
• Recurrent Anal Cancer

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish Centre for Particle Therapy	Aarhus N	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	MRI	12 months
Secondary	Local re-recurrence		6 and 24 months
Secondary	Progression free survival		3-5 year FU
Secondary	Overall survival		3-5 year FU
Secondary	Pathological evaluation of R0, R1 or R2 resection		6 months
Secondary	Toxicity	evaluated by NCI-CTCAE v. 5.0	up to 6 weeks, 1 year, 3 year
Secondary	Quality of life assessment	EORTC QLQ-c30	up to 6 weeks, 1 year, 3 year
Secondary	Quality of life assessment	QLQ-CR29	up to 6 weeks, 1 year, 3 year
Secondary	Quality of life assessment	QLQ-ANL27	up to 6 weeks, 1 year, 3 year
Secondary	Quality of life assessment	LARS score	up to 6 weeks, 1 year, 3 year
Secondary	Translational research	cfDNA	baseline, end of therapy, 1 year
Secondary	Summed radiotherapy dose volume to organs at risk and correlation to toxicities		up to 6 weeks, 1 year, 3 year
Secondary	To investigate 30-day surgical overall morbidity	Clavien-Dindo	30-day
Secondary	To investigate 6-month surgical site morbidity		6 months