NCT04695782

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
30mo left

Started Oct 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Oct 2020Oct 2028

Study Start

First participant enrolled

October 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Expected
Last Updated

January 5, 2021

Status Verified

October 1, 2020

Enrollment Period

5.1 years

First QC Date

January 4, 2021

Last Update Submit

January 4, 2021

Conditions

Rectal Cancer Recurrent

Outcome Measures

Primary Outcomes (2)

  • R0-resection

    Neo-adjuvant treatment: Rate of pathological complete resection (R0)

    5-6 years

  • 1-year local control

    Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.

    6-7 years

Secondary Outcomes (5)

  • Local recurrence

    6-8 years

  • Disease free survival

    10 years

  • Overall survival

    10 years

  • Toxicity

    5-7 years

  • Patient reported outcomes

    5-7 year

Study Arms (2)

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

EXPERIMENTAL
Radiation: Pencil beam proton radiotherapy

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

EXPERIMENTAL
Radiation: Pencil beam proton radiotherapy

Interventions

Pencil beam proton radiotherapyRADIATION

Doseescalated pencil beam proton Therapy

Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two dailyNeo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Centre for Particle Therapy

Aarhus, 8200, Denmark

RECRUITING

Central Study Contacts

Camilla Kronborg, MD, PhD

CONTACT

+45 78450000camkro@rm.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 5, 2021

Study Start

October 10, 2020

Primary Completion

October 31, 2025

Study Completion (Estimated)

October 31, 2028

Last Updated

January 5, 2021

Record last verified: 2020-10

Locations

DK(1)