NCT02422563

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
534

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

5 years

First QC Date

February 11, 2015

Last Update Submit

April 20, 2015

Conditions

Cervical Cancer

Keywords

neoadjuvant chemotherapyFIGO IB2, FIGO IIBchemo-radiationdose dense chemotherapycisplatinpaclitaxelcarboplatinifosfamide

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    DFS

    5 years

Secondary Outcomes (3)

  • overall survival

    5 years

  • local control

    5 years

  • quality of life

    5 years

Study Arms (2)

Arm A: NACT+radical hysterectomy

EXPERIMENTAL

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: hysterectomyDrug: CisplatinDrug: PaclitaxelDrug: CarboplatinDrug: Ifosfamide

Arm B: Chemoradiation

OTHER

Arm B includes patients undergoing primary cisplatin based chemo-radiation

Radiation: RadiationDrug: Cisplatin

Interventions

hysterectomyPROCEDURE

radical hysterectomy

Arm A: NACT+radical hysterectomy
RadiationRADIATION
Arm B: Chemoradiation
CisplatinDRUG
Arm A: NACT+radical hysterectomyArm B: Chemoradiation
PaclitaxelDRUG
Arm A: NACT+radical hysterectomy
CarboplatinDRUG
Arm A: NACT+radical hysterectomy
IfosfamideDRUG
Arm A: NACT+radical hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • cervical cancer FIGO IB2, IIB,
  • squamous cell, adeno or adenosquamous cell carcinoma
  • informed consent

You may not qualify if:

  • small cell/neuroendocrine component
  • previous radiation, previous cancer
  • pregnancy
  • HIV
  • severe co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Sardi JE, di Paola GR, Cachau A, Ortiz OC, Sananes C, Giaroli A, Martins D, Peluffo M. A possible new trend in the management of the carcinoma of the cervix uteri. Gynecol Oncol. 1986 Oct;25(2):139-49. doi: 10.1016/0090-8258(86)90095-8.

    PMID: 2428700BACKGROUND

  • Benedetti-Panici P, Greggi S, Colombo A, Amoroso M, Smaniotto D, Giannarelli D, Amunni G, Raspagliesi F, Zola P, Mangioni C, Landoni F. Neoadjuvant chemotherapy and radical surgery versus exclusive radiotherapy in locally advanced squamous cell cervical cancer: results from the Italian multicenter randomized study. J Clin Oncol. 2002 Jan 1;20(1):179-88. doi: 10.1200/JCO.2002.20.1.179.

    PMID: 11773168BACKGROUND

  • Sardi J, Sananes C, Giaroli A, Maya G, di Paola G. Neoadjuvant chemotherapy in locally advanced carcinoma of the cervix uteri. Gynecol Oncol. 1990 Sep;38(3):486-93. doi: 10.1016/0090-8258(90)90096-4.

    PMID: 1699851BACKGROUND

  • Souhami L, Gil RA, Allan SE, Canary PC, Araujo CM, Pinto LH, Silveira TR. A randomized trial of chemotherapy followed by pelvic radiation therapy in stage IIIB carcinoma of the cervix. J Clin Oncol. 1991 Jun;9(6):970-7. doi: 10.1200/JCO.1991.9.6.970.

    PMID: 1709686BACKGROUND

  • Gadducci A, Sartori E, Maggino T, Zola P, Cosio S, Zizioli V, Lapresa M, Piovano E, Landoni F. Pathological response on surgical samples is an independent prognostic variable for patients with Stage Ib2-IIb cervical cancer treated with neoadjuvant chemotherapy and radical hysterectomy: an Italian multicenter retrospective study (CTF Study). Gynecol Oncol. 2013 Dec;131(3):640-4. doi: 10.1016/j.ygyno.2013.09.029. Epub 2013 Oct 3.

    PMID: 24096111BACKGROUND

  • Lissoni AA, Colombo N, Pellegrino A, Parma G, Zola P, Katsaros D, Chiari S, Buda A, Landoni F, Peiretti M, Dell'anna T, Fruscio R, Signorelli M, Grassi R, Floriani I, Fossati R, Torri V, Rulli E. A phase II, randomized trial of neo-adjuvant chemotherapy comparing a three-drug combination of paclitaxel, ifosfamide, and cisplatin (TIP) versus paclitaxel and cisplatin (TP) followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the Snap-02 Italian Collaborative Study. Ann Oncol. 2009 Apr;20(4):660-5. doi: 10.1093/annonc/mdn690. Epub 2009 Jan 30.

    PMID: 19181826BACKGROUND

  • Buda A, Fossati R, Colombo N, Fei F, Floriani I, Gueli Alletti D, Katsaros D, Landoni F, Lissoni A, Malzoni C, Sartori E, Scollo P, Torri V, Zola P, Mangioni C. Randomized trial of neoadjuvant chemotherapy comparing paclitaxel, ifosfamide, and cisplatin with ifosfamide and cisplatin followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the SNAP01 (Studio Neo-Adjuvante Portio) Italian Collaborative Study. J Clin Oncol. 2005 Jun 20;23(18):4137-45. doi: 10.1200/JCO.2005.04.172.

    PMID: 15961761BACKGROUND

  • 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.

    PMID: 24342439BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

HysterectomyRadiationCisplatinPaclitaxelCarboplatinIfosfamide

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativePhysical PhenomenaChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Simone Marnitz, MD

CONTACT

simone.marnitz@charite.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. S. Marnitz

Study Record Dates

First Submitted

February 11, 2015

First Posted

April 21, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 1, 2025

Last Updated

April 21, 2015

Record last verified: 2015-04