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

Rectal Cancer Recurrent Clinical Trial

— ReRad II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04695782
• Other study ID #: DCPT221020
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2020
• Est. completion date: October 31, 2028

Study information

• Verified date: October 2020
• Source: University of Aarhus
• Contact: Camilla Kronborg, MD, PhD
• Phone: +45 78450000
• Email: camkro[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: October 31, 2028
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer Recurrent
• Rectal Neoplasms
• Recurrence

Intervention

Radiation:
• Pencil beam proton radiotherapy
Doseescalated pencil beam proton Therapy

Locations

Country	Name	City	State
Denmark	Danish Centre for Particle Therapy	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0-resection	Neo-adjuvant treatment: Rate of pathological complete resection (R0)	5-6 years
Primary	1-year local control	Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.	6-7 years
Secondary	Local recurrence	Local re-recurrence determined by imaging 6, 12 and 24 month post treatment	6-8 years
Secondary	Disease free survival	Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course	10 years
Secondary	Overall survival	Overall survival defined as time from first day of treatment to death from any cause	10 years
Secondary	Toxicity	Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic	5-7 years
Secondary	Patient reported outcomes	Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic	5-7 year