Clinical trial NCT01049100: Surgical Staging in Cervical Cancer Prior to Chemoradiation
Official title: Prospective, Randomised and Multi-centric Therapy Optimisation Study for Examining the Influence of Surgical Staging on the Oncological Results for Patients With Cervix Carcinoma of the FIGO Stages IIB-IV After Chemoradiation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: Surgical Staging
Cervical Cancer
Chemoradiation
Outcome
Toxicity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
name: Arbeitsgemeinschaft Radiologische Onkologie
First posted: 2010-01-14
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: DFS (disease-free survival)
timeFrame: 4 years
Secondary outcomes:
measure: OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity)
timeFrame: 4 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin
city: Berlin
country: Germany
facility: Department of Radiooncology, Charité Campus Mitte und Campus Virchow
Study officials:
affiliation: Department of Radiooncology (Charité Campus Mitte und Virchow), Charitéplatz 1, 10117 Berlin, Germany
name: Simone Marnitz, PD
role: STUDY_CHAIR
affiliation: Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin), Charitéplatz 1, 10117 Berlin, Germany
name: Christhardt Köhler, Prof.
role: STUDY_CHAIR
affiliation: Department of Gynaecology (Charité Campus Mitte), Charitéplatz 1, 10117 Berlin, Germany
name: Anja Dittgen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.