Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2028-10-31

Brief Summary

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Study design:

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.

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Detailed Description

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Conditions

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Rectal Cancer Recurrent

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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Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily

Group Type EXPERIMENTAL

Pencil beam proton radiotherapy

Intervention Type RADIATION

Doseescalated pencil beam proton Therapy

Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily

Group Type EXPERIMENTAL

Pencil beam proton radiotherapy

Intervention Type RADIATION

Doseescalated pencil beam proton Therapy

Interventions

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Pencil beam proton radiotherapy

Doseescalated pencil beam proton Therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* • Locally recurrent rectal cancer.

* Bioptically verified (adenocarcinoma )
* Available dose plan from primary radiotherapy
* Previous pelvic RT (\>30Gy EQD2)
* Evaluated in MDT-conferences (Herlev, Aarhus)
* Age\>18 years
* PS 0-2
* Adequate organ function
* Informed consent

Exclusion Criteria

* Non-resectable distant metastases (PET-CT)
* Unable to undergo MRI, PET-CT
* Inability to attend full course radiotherapy and follow up in the out patient clinic.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No