Randomized trial of vaginal brachytherapy vs observation for high-intermediate risk endometrial carcinoma
PORTEC - 4
Groningen
Waddenzee Friesland
Drenthe Noord Ijsselmeer Holland
Flevoland Overijssel
Gelderland Zuid Holland Utrecht
Noord Brabant
Zeeland Limburg PORTEC-2: results
Vaginal Recurrence Sexual activity
p=0.78
1.6 vs 1.8%
2 Nout et al, Lancet 2010; ESTRO 2010 Questions after PORTEC-2
• More atrophy in patients who had vaginal brachytherapy Is 21 Gy in 3 fractions at 5 mm the optimal dose? Many other schedules with lower doses seem equally effective • Should we treat all HIR patients or treat only for relapse? No survival difference!
PORTEC-4 design
• HIR endometrial carcinoma • 21 Gy in 3 fractions vs 15 Gy in 3 fractions • Vaginal brachytherapy vs no further treatment
1 VBT 3 x 7 Gy at 5 mm
2 1 R VBT 3 x 5 Gy at 5 mm 1 No further treatment Close FU; EBRT/VBT for vaginal relapse
4 PORTEC-4 eligibility
Inclusion (FIGO 2009): • Stage IA, any age, grade 3 without LVSI • Stage IB, age > 60 years, grade 1 or 2 • Stage IB, any age, grade 1 or 2 with LVSI
Endpoints: • Vaginal recurrence / 5-year vaginal control • Survival and relapse • Vaginal mucosal toxicity, Quality of life
Groningen
Waddenzee Friesland
Drenthe Noord Ijsselmeer Holland
Flevoland Overijssel
Gelderland Zuid Holland Utrecht
Noord Brabant
Zeeland Limburg Statistics
R 2 1
VBT No further treatment
3 x 7 Gy 3 x 5 Gy
• 10% vs 2.5%; power 90% • 3x5 Gy: estimate of VRR (se<2.5%)
Groningen • N = 500 Waddenzee Friesland
Drenthe Noord Ijsselmeer Holland
Flevoland Overijssel
Gelderland Zuid Holland Utrecht
Noord Brabant
Zeeland 4 Limburg PORTEC-4
• Upfront pathology review: Regional gynecologic pathologist • Funding by Dutch Cancer Society • Central Ethics approval • Local approval and dummy run procedures ongoing for some centres
Study activated 1 September 2012
Groningen
Waddenzee Friesland
Drenthe Noord Ijsselmeer Holland
Flevoland Overijssel
Gelderland Zuid Holland Utrecht
Noord Brabant
Zeeland Limburg PORTEC-4 accrual
Groningen
Waddenzee Friesland
Drenthe Noord Ijsselmeer Holland
Flevoland Overijssel
Gelderland Zuid Holland Utrecht
Noord Brabant
Zeeland Limburg PORTEC-4
Radiation oncologist: eligibility Pathology review: confirm pathology diagnosis Informed consent procedure Baseline quality of life
Randomisation
Vaginal brachytherapy 2 1 Observation
1 1
Brachytherapy Brachytherapy EBRT+VBT in case of 3x7 Gy HDR at 5 mm 3x5 Gy HDR at 5 mm recurrence
Groningen
Waddenzee Friesland
Drenthe Noord Ijsselmeer Holland
Flevoland Overijssel
Gelderland Follow-up and Quality of Life Zuid Holland Utrecht
Noord Brabant
Zeeland Limburg