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

Phase 2

Recruiting

• Conditions: Rectal Cancer Recurrent
• Interventions: Radiation: Pencil beam proton radiotherapy

• Registration Number: NCT04695782
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-10
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2025-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily	Pencil beam proton radiotherapy	-
Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily	Pencil beam proton radiotherapy	-

Primary Outcome Measures

Name	Time	Method
R0-resection	5-6 years	Neo-adjuvant treatment: Rate of pathological complete resection (R0)
1-year local control	6-7 years	Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.

Secondary Outcome Measures

Name	Time	Method
Local recurrence	6-8 years	Local re-recurrence determined by imaging 6, 12 and 24 month post treatment
Toxicity	5-7 years	Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic
Patient reported outcomes	5-7 year	Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic
Disease free survival	10 years	Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course
Overall survival	10 years	Overall survival defined as time from first day of treatment to death from any cause

Trial Locations

Locations (1)

Danish Centre for Particle Therapy; 🇩🇰 Aarhus, Denmark