Surgical Staging in Cervical Cancer Prior to Chemoradiation

Cervical Cancer Clinical Trial

— uterus11  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01049100
• Other study ID #: 108771
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2010
• Last updated: January 14, 2010
• Start date: April 2009
• Est. completion date: April 2017

Study information

• Verified date: August 2009
• Source: Charite University, Berlin, Germany
• Contact: Simone Marnitz, PD
• Phone: 004930450627162
• Email: simone.marnitz[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2017
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• lymphadenectomy
paraaortal and pelvic lymphadenectomy laparoscopic or open

Other:
• 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

Locations

Country	Name	City	State
Germany	Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin	Berlin
Germany	Department of Radiooncology, Charité Campus Mitte und Campus Virchow	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Arbeitsgemeinschaft Radiologische Onkologie, Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Bye A, Tropé 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. — View 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. — View 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. — View Citation

Marnitz S, Köhler C, Roth C, Füller 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. — View 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. — View 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. Epub 2007 Jun 27. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS (disease-free survival)		4 years	Yes
Secondary	OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity)		4 years	Yes

External Links

•   Association for Radiooncology
•   Websites of the Association of Gynecological Cancer and Society of Radiooncology, Germany