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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily | Experimental |
| |
| Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pencil beam proton radiotherapy | Radiation | Doseescalated pencil beam proton Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence | Local re-recurrence determined by imaging 6, 12 and 24 month post treatment | 6-8 years |
| 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 |
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Inclusion Criteria:
• Locally recurrent rectal cancer.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camilla Kronborg, MD, PhD | Contact | +45 78450000 | camkro@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Centre for Particle Therapy | Recruiting | Aarhus | 8200 | Denmark |
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| 10 years |
| Overall survival | Overall survival defined as time from first day of treatment to death from any cause | 10 years |
| Toxicity | Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic | 5-7 years |
| 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 |