CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 65 target
Drug / intervention
Pencil beam proton radiotherapyradiation
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Locally recurrent rectal cancer
  • ✓Biopsy-verified adenocarcinoma
  • ✓Available dose plan from primary radiotherapy
  • ✓Prior pelvic radiotherapy >30Gy EQD2
Key exclusion· 3
  • ✕Non-resectable distant metastases on PET-CT
  • ✕Unable to undergo MRI or PET-CT
  • ✕Unable to attend full course of radiotherapy and follow-up

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04695782
NCT04695782Phase 2RecruitingUpdate OverdueUpdated 65mo ago · Completion was 8mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

University of Aarhus·interventional·Posted Jan 5, 2021·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating Pencil beam proton radiotherapy for Rectal Cancer Recurrent. Currently recruiting, targeting 65 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer Recurrent
CountriesDenmark
Collaborators--

Timeline

Phase 2Recruiting
202120222023202420252026202720282029
First PostedJan 5, 2021
Enrollment StartOct 10, 2020
Primary CompletionOct 31, 2025
Study CompletionOct 31, 2028
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 5.5 years ago

Interventions

Pencil beam proton radiotherapyradiation

Doseescalated pencil beam proton Therapy