Surgical Staging in Cervical Cancer Prior to Chemoradiation
NCT ID: NCT01049100
Last Updated: 2010-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2009-04-30
2017-04-30
Brief Summary
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Detailed Description
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To this end, 250 patients with histologically verified cancer of the cervix uteri of the stages IIB-IV shall be randomised to a standard arm (ARM B), whereby the therapy shall be conducted on the basis of the clinical FIGO stage.
The patients randomised to the test arm (Arm A), after determining the clinical FIGO stage, shall initially receive an operative staging in the form of a pelvine paraaortal lymphadenectomy (laparoscopic or open). On the basis of the operatively obtained findings, a ("surgically") modified tumour stage shall be determined. This "surgical" tumour stage, which shall take into account the affection of the lymph nodes, the infiltration of the neighbouring organs and the intraperitoneal spread, shall serve as the basis for the execution of primary, combined radio-chemotherapy. The primary end-point is the disease-free survival of both groups, the secondary endpoints are overall survival, the local control of both groups, as well as the determination of toxicity and the quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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operative staging (A)
operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open
lymphadenectomy
paraaortal and pelvic lymphadenectomy laparoscopic or open
Standard (B)
No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--\> CT controlled biopsy and histological analysis.
Standard Staging
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
Interventions
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lymphadenectomy
paraaortal and pelvic lymphadenectomy laparoscopic or open
Standard Staging
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age between 18 - 70 years
* histological assured cervical cancer (by biopsy)
* FIGO stages II B - IV
* written informed consent
* patient's ability to cooperate
Exclusion Criteria
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Arbeitsgemeinschaft Radiologische Onkologie
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Department of Radiooncology (Charité Campus Mitte und Virchow) / Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin)
Principal Investigators
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Simone Marnitz, PD
Role: STUDY_CHAIR
Department of Radiooncology (Charité Campus Mitte und Virchow), Charitéplatz 1, 10117 Berlin, Germany
Christhardt Köhler, Prof.
Role: STUDY_CHAIR
Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin), Charitéplatz 1, 10117 Berlin, Germany
Anja Dittgen
Role: PRINCIPAL_INVESTIGATOR
Department of Gynaecology (Charité Campus Mitte), Charitéplatz 1, 10117 Berlin, Germany
Locations
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Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin
Berlin, , Germany
Department of Radiooncology, Charité Campus Mitte und Campus Virchow
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Association for Radiooncology
Other Identifiers
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108771
Identifier Type: -
Identifier Source: org_study_id
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