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

Phase 3

Not yet recruiting

• Conditions: Cervical Cancer
• Interventions: Procedure: hysterectomy; Radiation: Radiation; Drug: Cisplatin; Drug: Paclitaxel; Drug: Carboplatin; Drug: Ifosfamide

• Registration Number: NCT02422563
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Study Timeline

• Study First Submitted: 2015-02-11
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-20
• Last Update Submitted: 2015-04-20
• Study First Posted: 2015-04-21
• Last Update Posted: 2015-04-21
• Study Start: 2015-10
• Primary Completion: 2020-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 534

Inclusion Criteria

• >18 years
• cervical cancer FIGO IB2, IIB,
• squamous cell, adeno or adenosquamous cell carcinoma
• informed consent

Exclusion Criteria

• small cell/neuroendocrine component
• previous radiation, previous cancer
• pregnancy
• HIV
• severe co-morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: NACT+radical hysterectomy	hysterectomy	Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
Arm B: Chemoradiation	Radiation	Arm B includes patients undergoing primary cisplatin based chemo-radiation
Arm A: NACT+radical hysterectomy	Cisplatin	Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
Arm A: NACT+radical hysterectomy	Carboplatin	Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
Arm A: NACT+radical hysterectomy	Ifosfamide	Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
Arm A: NACT+radical hysterectomy	Paclitaxel	Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
Arm B: Chemoradiation	Cisplatin	Arm B includes patients undergoing primary cisplatin based chemo-radiation

Primary Outcome Measures

Name	Time	Method
disease free survival	5 years	DFS

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years
local control	5 years	local control rate at 5 years
quality of life	5 years	Qol questionnaire EORTC Qol C30 and Cervical Cancer Module EORTC QLQ-CX24