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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05055635

Acronym

ReRad III

Enrollment

Registered

2021-09-24

Start date

2021-07-07

Completion date

2030-07-06

Last updated

2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer, Recurrent Anal Cancer

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.

Interventions

RADIATIONPencil 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Local control	12 months	MRI

Secondary

Measure	Time frame	Description
Progression free survival	3-5 year FU	—
Overall survival	3-5 year FU	—
Pathological evaluation of R0, R1 or R2 resection	6 months	—
Toxicity	up to 6 weeks, 1 year, 3 year	evaluated by NCI-CTCAE v. 5.0
Local re-recurrence	6 and 24 months	—
Translational research	baseline, end of therapy, 1 year	cfDNA
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
To investigate 6-month surgical site morbidity	6 months	—
Quality of life assessment	up to 6 weeks, 1 year, 3 year	EORTC QLQ-c30

Countries

Denmark

Contacts

Primary ContactCamilla Kronborg, MD, PhD

camkro@rm.dk+45 78 45 00 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026