Sentinel Concept in Early Stage Cervical Cancer

NCT01157962 | Unknown DMC

• 1 other identifier: EA1/207/09
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

Sentinel Concept; Lymphadenectomy; Early Stage Cervical Cancer; Overall Survive; Improvement Therapy

Outcome Measures

Primary Outcomes (1)

• overall survival

  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.

  one year

Secondary Outcomes (1)

• morbidity

  one year

Study Arms (2)

Group A Sentinel lymphadenectomy

EXPERIMENTAL

In group A exclusively sentinel lymphadenectomy is performed

Procedure: Lymphadenectomy in cervical cancer

Group B radical pelvine lymphadenectomy

ACTIVE COMPARATOR

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

Interventions

Lymphadenectomy in cervical cancer PROCEDURE

Sentinel lymphadenectomy vs systematic pelvic lymphadenectomy

Also known as: Sentinel node dissection and radical pelvic dissection

Group A Sentinel lymphadenectomy; Group B radical pelvine lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charite University of Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (1)

• Altgassen C, Hertel H, Brandstadt A, Kohler C, Durst M, Schneider A; AGO Study Group. Multicenter validation study of the sentinel lymph node concept in cervical cancer: AGO Study Group. J Clin Oncol. 2008 Jun 20;26(18):2943-51. doi: 10.1200/JCO.2007.13.8933.

  PMID: 18565880 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: July 8, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2018
• Last Updated: July 1, 2011

Record last verified: 2009-12

Locations

DE (1)