Trial name | Phase | Interventions | Radiation details | Primary endpoint | Current status |
OUTBACK NCT01414608 | Ⅲ 2012–2018 | Control: CCRT Investigational: CCRT+adjuvant CT (paclitaxel+carboplatin) Enrollment: 926 participants | EBRT: 3D-CRT BT: 2D-ICBT, 3D-CT/MRI-based IGBT (IC/IS BT is not allowed) | OS | ASCO 2021 Plenary8
CCRT+adjuvant CT vs CCRT OS at 5 years: 72% vs 71% (HR 0.91) PFS at 5 years: 63% vs 61% (HR 0.87) NS in OS and PFS |
TACO NCT01561586 | Ⅲ 2012–2023 | Control: CCRT Investigational: CCRT (triweekly CDDP) Enrollment: 374 participants | EBRT: 2D-/3D-CRT BT: 2D-ICBT, 3D-CT/MRI-based IGBT (IC/IS BT is not allowed) | OS | Active, not recruiting |
INTERLACE NCT01566240 | Ⅲ 2012–2026 | Control: CCRT Investigational: NAC (paclitaxel+carboplatin) →CCRT Enrollment: 500 participants | EBRT: 3D-CRT, IMRT BT: 2D-ICBT, 3D-CT/MRI-based IGBT (IC/IS BT if indicated) | OS | Active, not recruiting |
CALLA NCT03830866 | Ⅲ 2019–2023 | Control: CCRT Investigational: CCRT+durvalumab (Concurrent→adjuvant) Enrollment: 770 participants | EBRT: 3D-CRT or IMRT BT: 2D-ICBT, 3D-CT/MRI-based IGBT (IC/IS BT if indicated) | PFS | IGCS 2022 Plenary9
Durvalumab+CCRT vs placebo+CCRT HR 0.84 (95% CI 0.65–1.08); p=0.174 N.S. in PFS |
MK-3475-A18/ KEYNOTE-A18/ ENGOT-cx11/ GOG-3047 NT04221945 | Ⅲ 2020–2024 | Control: CCRT Investigational: CCRT+pembrolizumab (Concurrent→adjuvant) Enrollment: 980 participants | EBRT: 3D-CRT or IMRT BT: 2D-ICBT, 3D-CT/MRI-based IGBT (IC/IS BT if indicated) | PFS at 38 months OS at 46 months |
J Clin Oncol 202010
Active, not recruiting |
NRG-GY006 NCT02466971 | Ⅲ 2016–2023 | Control: CCRT Investigational: CCRT+triapine Enrollment: 450 participants | EBRT: 3D-CRT or IMRT BT: 2D-ICBT, 3D-CT/MRI-based IGBT (IC/IS BT if indicated) | OS | Active, not recruiting |
EMBRACE Ⅱ NCT03617133 | Ⅱ 2016–2031 | Control: CCRT (Historical: Retro-/EMBRACE) Investigational: CCRT Enrollment: 1000 participants | EBRT: IMRT BT: 3D-MRI-based IGBT (IC/IS BT if indicated) Increased use of IC/IS BT, reduction of vaginal source loading, protocol for target and OAR contouring, EBRT dose prescription and reporting, adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence, use of IMRT and IGRT for EBRT delivery, reduction of overall treatment time | Local control for 5 years, nodal control for 5 years, systemic control for 5 years, OS for 5 years, overall morbidity for 5 years, EORTC QoL for 5 years |
Int J Radiat Oncol Biol Phys 201941
Active, not recruiting |
ASCO, American Society of Clinical Oncology; BT, brachytherapy; CCRT, concurrent chemoradiation therapy plus brachytherapy; CI, confidence interval; CR, complete response; CRT, conformal radiotherapy; CT, computed tomography; CT, chemotherapy; CTV, clinical target volume; 2D, two-dimensional; 3D, three-dimensional; EBRT, external beam radiotherapy; EORTC, European Organization for Research and Treatment of Cancer; HR, hazard ratio; HR-QoL, health-related quality of life; ICBT, intracavitary brachytherapy; IC/IS, intracavitary/interstitial; IGBT, image-guided brachytherapy; IGCS, International Gynecologic Cancer Society; IMRT, intensity-modulated radiation therapy; MRI, magnetic resonance imaging; NAC, neoadjuvant chemotherapy; NS, no statistically significant improvement; OAR, organs at risk; PFS, progression-free survival; PR, partial response; QoL, quality of life.