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

NCT ID: NCT05055635

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2030-07-06

Brief Summary

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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

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Conditions

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Anal Cancer Recurrent Anal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pencil beam proton therapy

Intervention Type RADIATION

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

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danish Centre for Particle Therapy

Aarhus N, Aarhus, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Camilla Kronborg, MD, PhD

Role: CONTACT

+45 78 45 00 00

Facility Contacts

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Camilla Kronborg, MD, PhD

Role: primary

+45 7845 0000

Other Identifiers

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DCPT070721

Identifier Type: -

Identifier Source: org_study_id

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