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

ConditionRectal Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Locally recurrent rectal cancer.

Bioptically verified (adenocarcinoma )

Available dose plan from primary radiotherapy

Previous pelvic RT (>30Gy EQD2)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pencil beam proton radiotherapy

    Radiation

    Doseescalated pencil beam proton Therapy

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two dailyExperimental treatment 1 intervention
Group B: Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two dailyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

R0-resection

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

Time frame
5-6 years
2

1-year local control

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

Time frame
6-7 years

Secondary outcomes

1

Local recurrence

Local re-recurrence determined by imaging 6, 12 and 24 month post treatment

Time frame
6-8 years
2

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

Time frame
10 years
3

Overall survival

Overall survival defined as time from first day of treatment to death from any cause

Time frame
10 years
4

Toxicity

Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic

Time frame
5-7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Source ClinicalTrials.gov
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