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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04695782

Acronym

ReRad II

Enrollment

Registered

2021-01-05

Start date

2020-10-10

Completion date

2028-10-31

Last updated

2021-01-05

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

Conditions

Rectal Cancer Recurrent

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.

Interventions

RADIATIONPencil beam proton radiotherapy

Doseescalated pencil beam proton Therapy

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

* • 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Overall survival	10 years	Overall survival defined as time from first day of treatment to death from any cause
Local recurrence	6-8 years	Local re-recurrence determined by imaging 6, 12 and 24 month post treatment
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
Toxicity	5-7 years	Toxicity evaluated by NCI-CTCAE v. 5.0 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

Countries

Denmark

Contacts

Primary ContactCamilla Kronborg, MD, PhD

camkro@rm.dk+45 78450000

Outcome results

None listed

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