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

April 20, 2015 updated by: S. Marnitz, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

534

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: NACT+radical 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
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Ifosfamide
Procedure: hysterectomy
radical hysterectomy
Other: Arm B: Chemoradiation
Arm B includes patients undergoing primary cisplatin based chemo-radiation
Drug: Cisplatin
Radiation: Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 5 years
DFS
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
5 years
local control
Time Frame: 5 years
local control rate at 5 years
5 years
quality of life
Time Frame: 5 years
Qol questionnaire EORTC Qol C30 and Cervical Cancer Module EORTC QLQ-CX24
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NACOPRAD_2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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