NCT02422563

NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Cervical Cancer FIGO Stage IB2 and IIB

Multicenter Prospective Randomized Study on NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Patients With Cervical Cancer FIGO Stage IB2 and IIB

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 534 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB.

Detailed description

The optimal treatment for patients with cervical cancer on FIGO stage IB2 and IIB is controversial. There is no randomized comparison of a dose-dense NACT (TP or TIP-schedule) followed by hysterectomy and LNE (investigational Arm A) versus primary chemo-radiation (standard arm B). Primary endpoint is the DFS at 5 years, secondary endpoints local control at 5 years, OS at 5 years, QOL, questionnaires on sexual activity/QOL.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	hysterectomy	radical hysterectomy
RADIATION	Radiation
DRUG	Cisplatin
DRUG	Paclitaxel
DRUG	Carboplatin
DRUG	Ifosfamide

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-10-01
• Completion: 2025-10-01
• First posted: 2015-04-21
• Last updated: 2015-04-21