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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: hysterectomy
* Radiation: Radiation
* Drug: Cisplatin
* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: Ifosfamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | DFS | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant chemotherapy, FIGO IB2, FIGO IIB, chemo-radiation, dose dense chemotherapy, cisplatin, paclitaxel, carboplatin, ifosfamide