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

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ClinicalTrials.gov Identifier: NCT02422563
Recruitment Status : Not yet recruiting
First Posted : April 21, 2015
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
S. Marnitz, 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: hysterectomy Radiation: Radiation Drug: Cisplatin Drug: Paclitaxel Drug: Carboplatin Drug: Ifosfamide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


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
Procedure: hysterectomy
radical hysterectomy

Drug: Cisplatin
Drug: Paclitaxel
Drug: Carboplatin
Drug: Ifosfamide
Arm B: Chemoradiation
Arm B includes patients undergoing primary cisplatin based chemo-radiation
Radiation: Radiation
Drug: Cisplatin



Primary Outcome Measures :
  1. disease free survival [ Time Frame: 5 years ]
    DFS


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
  2. local control [ Time Frame: 5 years ]
    local control rate at 5 years

  3. quality of life [ Time Frame: 5 years ]
    Qol questionnaire EORTC Qol C30 and Cervical Cancer Module EORTC QLQ-CX24



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422563


Contacts
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Contact: Simone Marnitz, MD simone.marnitz@charite.de

Sponsors and Collaborators
Charite University, Berlin, Germany

Publications:

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Responsible Party: S. Marnitz, Prof. Dr. med. S. Marnitz, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02422563     History of Changes
Other Study ID Numbers: NACOPRAD_2015
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by S. Marnitz, Charite University, Berlin, Germany:
neoadjuvant chemotherapy
FIGO IB2, FIGO IIB
chemo-radiation
dose dense chemotherapy
cisplatin
paclitaxel
carboplatin
ifosfamide

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents