Clinical trial NCT02422563: NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Cervical Cancer FIGO Stage IB2 and IIB
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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: neoadjuvant chemotherapy
FIGO IB2, FIGO IIB
chemo-radiation
dose dense chemotherapy
cisplatin
paclitaxel
carboplatin
ifosfamide
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 534
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: local control
timeFrame: 5 years
measure: quality of life
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
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citation: Landoni F, Sartori E, Maggino T, Zola P, Zanagnolo V, Cosio S, Ferrari F, Piovano E, Gadducci A. Is there a role for postoperative treatment in patients with stage Ib2-IIb cervical cancer treated with neo-adjuvant chemotherapy and radical surgery? An Italian multicenter retrospective study. Gynecol Oncol. 2014 Mar;132(3):611-7. doi: 10.1016/j.ygyno.2013.12.010. Epub 2013 Dec 14.