Study: NCT05255653

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olaparib
Description: 300 mg twice daily for one year

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic external beam radiotherapy
Description: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Pelvic external beam radiotherapy
Description: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic external beam radiotherapy
Description: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Pelvic external beam radiotherapy
Description: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

Intervention type: RADIATION
Group type: OTHER
Intervention: Pelvic external beam radiotherapy
Description: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic external beam radiotherapy
Description: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Pelvic external beam radiotherapy
Description: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chemotherapy
Description: Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chemotherapy
Description: Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chemotherapy
Description: Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Chemotherapy
Description: Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Durvalumab
Description: 1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy,

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Medroxyprogesterone Acetate
Description: Oral medroxyprogesterone acetate for two years

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Megestrol Acetate
Description: Oral medroxyprogesterone acetate for two years

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Vaginal brachytherapy
Description: Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI. Brachytherapy is given with a vaginal cylinder or vaginal ovoids or ring applicator, according to the center's standard technique. When using a cylinder, the active length will ideally be 2-3 cm, with the reference isodose covering the proximal 2.5-3 cm of the vagina. High-dose-rate (HDR) and pulse-dose-rate (PDR) schedules are permitted, which deliver an EQD2 equivalent dose of 10-14 Gy at 5 mm from the vaginal mucosa (to obtain a cumulative EDQ2 of 60 Gy at 5 mm).

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Vaginal brachytherapy
Description: Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI. Brachytherapy is given with a vaginal cylinder or vaginal ovoids or ring applicator, according to the center's standard technique. When using a cylinder, the active length will ideally be 2-3 cm, with the reference isodose covering the proximal 2.5-3 cm of the vagina. High-dose-rate (HDR) and pulse-dose-rate (PDR) schedules are permitted, which deliver an EQD2 equivalent dose of 10-14 Gy at 5 mm from the vaginal mucosa (to obtain a cumulative EDQ2 of 60 Gy at 5 mm).

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Vaginal brachytherapy
Description: Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI. Brachytherapy is given with a vaginal cylinder or vaginal ovoids or ring applicator, according to the center's standard technique. When using a cylinder, the active length will ideally be 2-3 cm, with the reference isodose covering the proximal 2.5-3 cm of the vagina. High-dose-rate (HDR) and pulse-dose-rate (PDR) schedules are permitted, which deliver an EQD2 equivalent dose of 10-14 Gy at 5 mm from the vaginal mucosa (to obtain a cumulative EDQ2 of 60 Gy at 5 mm).