Trial document
DRKS00003164
Trial Description
Title
Prospective, randomized and multicenter study for investigation of validity of the sentinel lymph node concept in patients with cervical cancer ≤ 2 cm
Trial Acronym
SENCER
URL of the Trial
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Brief Summary in Lay Language
Aim of the present study is to show, if only removal of sentinel lymph nodes in women with early cervical
cancer leads to an equal overall survival compared to systematic radical pelvic lymphadenectomy and at
the same time is accompanied with considerable reduction of intra- and post operative complications.
Brief Summary in Scientific Language
Aim of the present study is to show, if only removal of sentinel lymph nodes in women with early cervical
cancer leads to an equal overall survival compared to systematic radical pelvic lymphadenectomy and at
the same time is accompanied with considerable reduction of intra- and post operative complications.
We plan to randomize 1200 patients with histologically confirmed cervical cancer stage FIGO 1a1 L1 V0,
FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0 ≤ 2 cm. In group A exclusively sentinel lymphadenectomy is
performed, in group B radical systematic pelvic lymphadenectomy is done. All the patients from both groups with tumor free
lymph nodes either radical hysterectomy or, in women seeking parenthood, radical trachelectomy is
performed. In all patients, if lymph nodes are tumor-involved systematic pelvic and paraaortic lymphadenectomy
followed by primary chemoradiation is recommended.
Primary end point is overall survival which should be equal for both groups. Secondary end point is periand
postoperative morbidity including quality of life, where a benefit for women with sentinellymphadenectomy
should be evident.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00003164
- 2011/07/05
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- yes
- Approved
- EA1/207/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
Secondary IDs
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Health Condition or Problem studied
- cervical cancer
- C53.9 - Malignant neoplasm: Cervix uteri, unspecified
Interventions/Observational Groups
- sentinel lymphadenectomy
- radical pelvic lymphadenectomy
Characteristics
- Interventional
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- Randomized controlled trial
- Single blind
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- Active control
- Treatment
- Parallel
- N/A
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Primary Outcome
Overall survival
Secondary Outcome
Peri- and postoperative morbidity
Quality of life judged trough questionnaire EORTC QLQ C-30 (3 months after operation, then yearly till 4 year follow-up)
Recurrence-free survival
Countries of Recruitment
- Germany
- Poland
Locations of Recruitment
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Recruitment
- Planned
- 2011/09/01
- 1200
- Multicenter trial
- International
Inclusion Criteria
- Female
- 18 Years
- 80 Years
Additional Inclusion Criteria
- Karnofsky-Index =/> 70,
- 18-80 year of age
- Cervical cancer diagnosed histologically
- FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0 FIGO 1b1 L0 or L1 V0 ≤ 2cm
- Signed informed consent form
- Patient's willing to cooperate
Exclusion Criteria
- Neuroendocrine tumours or tumours of mixed type with neuroendocrine component
- Invasion of tumour cells in vascular system (V1)
- Pregnancy, breast feeding
- Distant metastases
- Previous malignant diseases
- History of pelvic radiotherapy
- Severe medical disorders
- Psychiatric diseases, that can interfere with participation and follow-up
- HIV infection or AIDS
- Drugs addiction
- Existing motoric or sensoric polyneuropathy > CTC Grad 1
- impossibility to perform anesthesia
Addresses
-
start of 1:1-Block address primary-sponsor
- Charité Campus Charité Mitte
- Charitéplatz 1
- 10117 Berlin
- Germany
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- http://www.charite.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinik für Gynäkologie mit Onkologie Charité Campus Mitte
- Mr. Professor Achim Schneider
- Charitèplatz 1
- 10117 Berlin
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 030 450 564 172
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- achim.schneider at charite.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik für Gynäkologie mit Onkologie Charité Campus Mitte
- Mr. Dr. Sergio Frangini
- Charitèplatz 1
- 10117 Berlin
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 030 450 664 138
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- sergio.frangini at charite.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Charité Campus Charité Mitte
- Charitéplatz 1
- 10117 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.charite.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
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Trial Publications, Results and other Documents
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