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Sentinel Concept in Early Stage Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2009 by Charite University, Berlin, Germany
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01157962
First received: June 22, 2010
Last updated: June 30, 2011
Last verified: December 2009
  Purpose

Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection.

For this purpose were randomized about 1200 patients with histological assured cervix carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy.

Primary end point is overall survival; this for both groups must be equal. Secondary end point is peri- and postoperative morbidity inclusive quality of life, the benefits for women must be evident with sentinel- lymph node dissection, don't have to show for both groups any significant difference.


Condition Intervention
Cervical Cancer
Procedure: Lymphadenectomy in cervical cancer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • overall survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Primary study end point is that overall survival of patients with sentinel-concept, has not to differentiate from that one of patients with systematic lymph node dissection.


Secondary Outcome Measures:
  • morbidity [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Secondary study end points are peri- und postoperative complications percentage and life quality after EORTC QLQ C-30 and local control. Local control percentage must exhibit no difference for both groups. Complications percentage and life quality must be significative better in branch with sentinel-lymph node dissection.


Estimated Enrollment: 1600
Study Start Date: January 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Sentinel lymphadenectomy
In group A exclusively sentinel lymphadenectomy is performed
Procedure: Lymphadenectomy in cervical cancer
Sentinel lymphadenectomy vs systematic pelvic lymphadenectomy
Other Name: Sentinel node dissection and radical pelvic dissection
Active Comparator: Group B radical pelvine lymphadenectomy
in group B radical systematic pelvic lymphadenectomy is done. In patients with tumor free lymph nodes either radical hysterectomy or, in women seeking parenthood, radical trachelectomy is performed. If lymph nodes are tumor-involved systematic pelvic and paraaortic lymphadenectomy followed by primary chemoradiation is recommended.
Procedure: Lymphadenectomy in cervical cancer
Sentinel lymphadenectomy vs systematic pelvic lymphadenectomy
Other Name: Sentinel node dissection and radical pelvic dissection

Detailed Description:

After randomization and assignment to experimental or control group lymphadenectomy is carried out.

Four different techniques can be used: 1) laparoscopic transperitoneal 2) laparoscopic retroperitoneal 3) open extraperitoneal 4) open transperitoneal. Radioactive labeling of sentinel-lymph nodes with 99technetium-marked colloid and/or patent blue is carried out. On the day prior to the operation 50mBq 99technetium or on the day of operation 10 mBq 99technetium is injected subepithelially in the cervix at 12, 3, 6 and 9 o'clock. Preoperatively 4 cc patent blue are injected in the same manner subepithelially. At the beginning of surgery parametrial tumor involvement, intrabdominal tumor dissemination, invasion of vesica-cervical and recto-vaginal septum are excluded. A lavage of cul-de-sac for cytological analysis is performed. The retroperitoneum is opened lateral of iliac vessels and blue colored lymph or radioactive nodes are removed. Sentinel- lymph node's radioactive signal is documented in counts per second (cps).

If no sentinel-lymph node is detected, complete pelvic lymph node dissection is carried out. If tumor involved pelvic lymph nodes are shown, paraaortic lymph node dissection is carried out. If sentinel- or pelvic lymph nodes are quoted as tumor free at frozen sections, radical hysterectomy or radical trachelectomy is performed. Radical hysterectomy follows in an extension a type-2 variation. In patients with positive lymph nodes in frozen section or in definitive histo-pathology primary chemoradiation is performed.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karnofsky index
  • Patients aged 18-70
  • Histological assured cervix cancer (Squamous epithelium- or Adenoids cancer, adenosquamous cancer)
  • Stadium FIGO from 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, till FIGO 1b1 L0 or L1 V0 ≤ 2cm
  • Completed and signed consent form
  • Cooperation qualities of patients
  • Performed explanation patients and written consent

Exclusion Criteria:

  • Tumour thickness > 2cm, FIGO- staging > 1b1
  • Neuroendocrine tumoural or mixed types with neuroendocrine tissues
  • Tumoural invasion in vascular system (V1)
  • Pregnancy, during lactation women without reliable contraception during radiochemotherapy
  • Existing malignant diseases (Exception: basalioma of the skin)
  • Radiotherapy of pelvis in anamnesis
  • Severe internal associated diseases (Myocardial infarction, Heart pathology, Heart insufficiency NYHA III/IV, Severe chronic obstructive bronchopulmonary disease, kidney insufficiency, diabetes mellitus poorly regulated, uncontrolled infections) Anaesthesia not allowed
  • Psychiatric diseases, which put off participating and after care
  • HIV infection, or rather AIDS disease
  • Drug addicted
  • Precedent motorial or sensorial Polyneuropathies>CTC grade 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157962

Locations
Germany
Charite University of Berlin Recruiting
Berlin, Germany, 10117
Contact: Achim Schneider, Professor    +49 30 450 564 172    achim.schneider@charite.de   
Principal Investigator: Achim Schneider, Professor         
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Campus Mitte/ Campus Benjamin Franklin Charité university, Gynecological Oncology Ward
ClinicalTrials.gov Identifier: NCT01157962     History of Changes
Other Study ID Numbers: EA1/207/09
Study First Received: June 22, 2010
Last Updated: June 30, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Sentinel Concept
Lymphadenectomy
Early Stage Cervical Cancer
Overall Survive
Improvement Therapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014