NCT01049100

Brief Summary

The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 15, 2010

Status Verified

August 1, 2009

Enrollment Period

4 years

First QC Date

January 13, 2010

Last Update Submit

January 14, 2010

Conditions

Cervical Cancer

Keywords

Surgical StagingCervical CancerChemoradiationOutcomeToxicity

Outcome Measures

Primary Outcomes (1)

  • DFS (disease-free survival)

    4 years

Secondary Outcomes (1)

  • OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity)

    4 years

Study Arms (2)

operative staging (A)

EXPERIMENTAL

operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open

Procedure: lymphadenectomy

Standard (B)

NO INTERVENTION

No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--\> CT controlled biopsy and histological analysis.

Other: Standard Staging

Interventions

lymphadenectomyPROCEDURE

paraaortal and pelvic lymphadenectomy laparoscopic or open

Also known as: debulking, surgical staging
operative staging (A)
Standard StagingOTHER

clinical Staging (FIGO) (examination in narcosis, biopsy, cystoscopy, rectoscopy) X-Ray Radiograph of Thorax, Ultrasound of abdomen, CT abdomen / pelvis positive, suspicious lymphnodes--\> CT controlled biopsy

Also known as: FIGO Staging
Standard (B)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Karnofsky-Index =/\> 70,
  • age between 18 - 70 years
  • histological assured cervical cancer (by biopsy)
  • FIGO stages II B - IV
  • written informed consent
  • patient's ability to cooperate

You may not qualify if:

  • neuroendocrine tumors or histological mixed types containing neuroendocrine fractions
  • pregnancy, lactation,
  • distant metastases, except paraaortal metastases
  • other malignant diseases in anamnesis
  • pelvic radiotherapy in anamnesis
  • severe internal diseases
  • psychiatric diseases which might query the trial attendance or follow-up
  • HIV-Infection or AIDS
  • drug addiction
  • existing motoric or sensoric polyneuropathy \> CTC Grad 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin

Berlin, 10117, Germany

RECRUITING

Department of Radiooncology, Charité Campus Mitte und Campus Virchow

Berlin, 10117, Germany

RECRUITING

Related Publications (7)

  • Sakuragi N. Up-to-date management of lymph node metastasis and the role of tailored lymphadenectomy in cervical cancer. Int J Clin Oncol. 2007 Jun;12(3):165-75. doi: 10.1007/s10147-007-0661-2. Epub 2007 Jun 27.

    PMID: 17566838BACKGROUND

  • Subak LL, Hricak H, Powell CB, Azizi L, Stern JL. Cervical carcinoma: computed tomography and magnetic resonance imaging for preoperative staging. Obstet Gynecol. 1995 Jul;86(1):43-50. doi: 10.1016/0029-7844(95)00109-5.

    PMID: 7784021BACKGROUND

  • Marnitz S, Kohler C, Roth C, Fuller J, Bischoff A, Wendt T, Schneider A, Budach V. Stage-adjusted chemoradiation in cervical cancer after transperitoneal laparoscopic staging. Strahlenther Onkol. 2007 Sep;183(9):473-8. doi: 10.1007/s00066-007-1675-4.

    PMID: 17762920BACKGROUND

  • Bye A, Trope C, Loge JH, Hjermstad M, Kaasa S. Health-related quality of life and occurrence of intestinal side effects after pelvic radiotherapy--evaluation of long-term effects of diagnosis and treatment. Acta Oncol. 2000;39(2):173-80. doi: 10.1080/028418600430734.

    PMID: 10859007BACKGROUND

  • Nag S, Erickson B, Thomadsen B, Orton C, Demanes JD, Petereit D. The American Brachytherapy Society recommendations for high-dose-rate brachytherapy for carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):201-11. doi: 10.1016/s0360-3016(00)00497-1.

    PMID: 10924990BACKGROUND

  • Lai CH, Huang KG, Hong JH, Lee CL, Chou HH, Chang TC, Hsueh S, Huang HJ, Ng KK, Tsai CS. Randomized trial of surgical staging (extraperitoneal or laparoscopic) versus clinical staging in locally advanced cervical cancer. Gynecol Oncol. 2003 Apr;89(1):160-7. doi: 10.1016/s0090-8258(03)00064-7.

    PMID: 12694671BACKGROUND

  • Denschlag D, Gabriel B, Mueller-Lantzsch C, Tempfer C, Henne K, Gitsch G, Hasenburg A. Evaluation of patients after extraperitoneal lymph node dissection for cervical cancer. Gynecol Oncol. 2005 Mar;96(3):658-64. doi: 10.1016/j.ygyno.2004.08.053.

    PMID: 15721408BACKGROUND

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Lymph Node Excision

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)

Surgical Procedures, Operative

Study Officials

  • Simone Marnitz, PD

    Department of Radiooncology (Charité Campus Mitte und Virchow), Charitéplatz 1, 10117 Berlin, Germany

    STUDY CHAIR

  • Christhardt Köhler, Prof.

    Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin), Charitéplatz 1, 10117 Berlin, Germany

    STUDY CHAIR

  • Anja Dittgen

    Department of Gynaecology (Charité Campus Mitte), Charitéplatz 1, 10117 Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Marnitz, PD

CONTACT

004930450627162simone.marnitz@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

April 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2017

Last Updated

January 15, 2010

Record last verified: 2009-08

Locations

DE(2)