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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02422563

Acronym

NACOPRAD

Enrollment

534

Registered

2015-04-21

Start date

2015-10-31

Completion date

2025-10-31

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

neoadjuvant chemotherapy, FIGO IB2, FIGO IIB, chemo-radiation, dose dense chemotherapy, cisplatin, paclitaxel, carboplatin, ifosfamide

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.

Interventions

PROCEDUREhysterectomy

radical hysterectomy

RADIATIONRadiation

DRUGCisplatin

DRUGPaclitaxel

DRUGCarboplatin

DRUGIfosfamide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
disease free survival	5 years	DFS

Secondary

Measure	Time frame	Description
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

Contacts

Primary ContactSimone Marnitz, MD

simone.marnitz@charite.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026