Clinical trial NCT01810874: STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
Official title: STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Neoplasms
Ovarian Neoplasms
Keywords: extraperitoneal
transperitoneal
laparoscopic aortic lymphadenectomy
endometrial ovarian cancer
ovarian cancer
surgical staging
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2013-03-14
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to FIGO (the International Federation of Gynecology and Obstetrics) recommendations
* Diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to FIGO recommendations

Exclusion Criteria:

* Diagnosis of advanced endometrial cancer based on findings on imaging techniques (CT, MRI and/or PET)
* Diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy)
* Patients who underwent previous aortic lymphadenectomy
* Patients who received previous pelvic and/or aortic radiotherapy

Primary outcomes:
measure: Number of lymph nodes
timeFrame: After aortic lymphadenectomy is completed
Secondary outcomes:
measure: Operative time
timeFrame: At the time of the surgery
measure: Intraoperative complications
timeFrame: At the time of surgery
measure: Early Postoperative complications
timeFrame: within 30 days after surgery
measure: Late Postoperative complications
timeFrame: past 30 days after surgery
measure: Overall survival
timeFrame: up to 3 years
measure: Disease-free survival
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Bacelona
country: Spain
facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
state: Barcelona
Study officials:
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Antonio Gil Moreno, M.D., PhD
role: STUDY_CHAIR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Berta Díaz Feijoo, M.D., PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Jose Luis Sánchez, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Alejandro Correa Paris, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: M. Assumpció Pérez-Benavente, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Silvia Cabrera Díaz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Silvia Franco Camps, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Oriol Puig Puig, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gil-Moreno A, Franco-Camps S, Cabrera S, Perez-Benavente A, Martinez-Gomez X, Garcia A, Xercavins J. Pretherapeutic extraperitoneal laparoscopic staging of bulky or locally advanced cervical cancer. Ann Surg Oncol. 2011 Feb;18(2):482-9. doi: 10.1245/s10434-010-1320-9. Epub 2010 Sep 14.
citation: Gil-Moreno A, Diaz-Feijoo B, Perez-Benavente A, del Campo JM, Xercavins J, Martinez-Palones JM. Impact of extraperitoneal lymphadenectomy on treatment and survival in patients with locally advanced cervical cancer. Gynecol Oncol. 2008 Sep;110(3 Suppl 2):S33-5. doi: 10.1016/j.ygyno.2008.03.024. Epub 2008 Jun 5.
citation: Gil-Moreno A, Maffuz A, Diaz-Feijoo B, Puig O, Martinez-Palones JM, Perez A, Garcia A, Xercavins J. Modified approach for extraperitoneal laparoscopic staging for locally advanced cervical cancer. J Exp Clin Cancer Res. 2007 Dec;26(4):451-8.
citation: Gil-Moreno A, Diaz-Feijoo B, Morchon S, Xercavins J. Analysis of survival after laparoscopic-assisted vaginal hysterectomy compared with the conventional abdominal approach for early-stage endometrial carcinoma: a review of the literature. J Minim Invasive Gynecol. 2006 Jan-Feb;13(1):26-35. doi: 10.1016/j.jmig.2005.08.013.
citation: Dowdy SC, Aletti G, Cliby WA, Podratz KC, Mariani A. Extra-peritoneal laparoscopic para-aortic lymphadenectomy--a prospective cohort study of 293 patients with endometrial cancer. Gynecol Oncol. 2008 Dec;111(3):418-24. doi: 10.1016/j.ygyno.2008.08.021. Epub 2008 Oct 2.
citation: Magrina JF, Kho R, Montero RP, Magtibay PM, Pawlina W. Robotic extraperitoneal aortic lymphadenectomy: Development of a technique. Gynecol Oncol. 2009 Apr;113(1):32-5. doi: 10.1016/j.ygyno.2008.11.038. Epub 2009 Jan 21.
citation: Franco-Camps S, Cabrera S, Perez-Benavente A, Diaz-Feijoo B, Bradbury M, Xercavins J, Gil-Moreno A. Extraperitoneal laparoscopic approach for diagnosis and treatment of aortic lymph node recurrence in gynecologic malignancy. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):570-5. doi: 10.1016/j.jmig.2010.03.020. Epub 2010 Jun 30.
citation: Diaz-Feijoo B, Correa-Paris A, Perez-Benavente A, Franco-Camps S, Sanchez-Iglesias JL, Cabrera S, de la Torre J, Centeno C, Puig OP, Gil-Ibanez B, Colas E, Magrina J, Gil-Moreno A. Prospective Randomized Trial Comparing Transperitoneal Versus Extraperitoneal Laparoscopic Aortic Lymphadenectomy for Surgical Staging of Endometrial and Ovarian Cancer: The STELLA Trial. Ann Surg Oncol. 2016 Sep;23(9):2966-74. doi: 10.1245/s10434-016-5229-9. Epub 2016 Apr 20.