Endometrial NeoplasmsSTELLA-2NCT02676726

STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

A study testing Extraperitoneal Laparoscopic aortic lymphadenectomy and Transperitoneal Laparoscopic aortic lymphadenectomy in people with Endometrial Neoplasms and Ovarian Neoplasms, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer Read more about this study

Who is it for?: Ages 18 to 85 years, women only
Conditions the study is for: Endometrial Neoplasms, Ovarian Neoplasms
What is being tested?: Extraperitoneal Laparoscopic aortic lymphadenectomy and Transperitoneal Laparoscopic aortic lymphadenectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 208 participants
Where: 1 siteSpain
Study dates: Jul 2014to 8 Sep 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Barcelona, 08035

Other trials in Spain

About this study

Official title: STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications

Conditions: Endometrial Neoplasms, Ovarian Neoplasms
Being tested: Extraperitoneal Laparoscopic aortic lymphadenectomy, Transperitoneal Laparoscopic aortic lymphadenectomy
Keywords: extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial cancer, ovarian cancer, surgical staging
Medical subject headings: Endometrial Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extraperitoneal Laparoscopic aortic lymphadenectomyProcedure or surgery
Also called Extraperitoneal laparoscopic para-aortic lymphadenectomy, Retroperitoneal laparoscopic lumbo-aortic lymphadenectomy
Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
Transperitoneal Laparoscopic aortic lymphadenectomyProcedure or surgery
Also called Transperitoneal laparoscopic para-aortic lymphadenectomy, Transperitoneal laparoscopic lumbo-aortic lymphadenectomy
Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Study groups in NCT02676726
Study group	Role	What they receive
Extraperitoneal	Experimental	Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy. Receives: Procedure: Extraperitoneal Laparoscopic aortic lymphadenectomy
Transperitoneal	Active comparator	Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy. Receives: Procedure: Transperitoneal Laparoscopic aortic lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical complications
Composite outcome defined by including at least one of the following:
- Total estimated blood loss > 500 mL during surgery
- Blood transfusion
- Intraoperative complication classified as Dindo grade III or worse, related to the aortic lymphadenectomy
- Early postoperative complication (within 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy
- Late postoperative complication (past 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy
- Conversion to laparotomy during the aortic lymphadenectomy
- Inability to complete the aortic lymphadenectomy
Measured: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery

Secondary outcomes (5)

Number of lymph nodes
The number of lymph nodes (absolute number) is specified by the pathologist on histopathological analysis of the sample sent by the surgeon after surgical staging is realized (laparoscopic aortic lymphadenectomy). This variable is subdivided into: supra-mesenteric and infra-mesenteric.
Measured: Postoperatively (within 1 week), at the moment of histopathologic examination
Operative time
Total duration of surgery (from initial skin incision to end of skin suture), and total aortic lymphadenectomy time (time spent since the beginning of aortic lymphadenectomy to its completion). Metric: minutes.
Measured: At the time of the surgery
Hospital stay
The number of days that patients stay in the hospital after surgery, measured in days from the day of the surgery to the day the patient is discharged from the hospital.
Measured: Measured the day the patient is discharged (up to 100 days)
Overall survival
Number of patients alive after surgery.
Measured: up to 3 years after surgery
Disease-free survival
Period of time in which there is no appearance of the symptoms or effects of the disease.
Measured: up to 3 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20148 Sep 2019

First posted8 Feb 2016 (estimated)
Study startJul 2014
Primary completionSep 2019
Study completion8 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02676726
Sponsor's protocol ID: P14/1817
Acronym: STELLA-2
Status last verified: Oct 2019
First submitted: 14 Oct 2015
Last updated: 24 Oct 2019
Results posted: No
Data monitoring committee: Yes

Publications

Vasilev SA, McGonigle KF. Extraperitoneal laparoscopic para-aortic lymph node dissection. Gynecol Oncol. 1996 Jun;61(3):315-20. doi: 10.1006/gyno.1996.0149.
PubMed 8641608
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.
PubMed 18835020
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.
PubMed 18365538
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.
PubMed 16431320
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.
PubMed 18538379
Gil-Moreno A, Franco-Camps S, Diaz-Feijoo B, Perez-Benavente A, Martinez-Palones JM, Del Campo JM, Parera M, Verges R, Castellvi J, Xercavins J. Usefulness of extraperitoneal laparoscopic paraaortic lymphadenectomy for lymph node recurrence in gynecologic malignancy. Acta Obstet Gynecol Scand. 2008;87(7):723-30. doi: 10.1080/00016340802136343.
PubMed 18607826
Pakish J, Soliman PT, Frumovitz M, Westin SN, Schmeler KM, Reis RD, Munsell MF, Ramirez PT. A comparison of extraperitoneal versus transperitoneal laparoscopic or robotic para-aortic lymphadenectomy for staging of endometrial carcinoma. Gynecol Oncol. 2014 Feb;132(2):366-71. doi: 10.1016/j.ygyno.2013.12.019. Epub 2013 Dec 20.
PubMed 24361579
Dowdy SC, Mariani A. Lymphadenectomy in endometrial cancer: when, not if. Lancet. 2010 Apr 3;375(9721):1138-40. doi: 10.1016/S0140-6736(09)62068-7. Epub 2010 Feb 24. No abstract available.
PubMed 20188409
Mariani A, Dowdy SC, Cliby WA, Gostout BS, Jones MB, Wilson TO, Podratz KC. Prospective assessment of lymphatic dissemination in endometrial cancer: a paradigm shift in surgical staging. Gynecol Oncol. 2008 Apr;109(1):11-8. doi: 10.1016/j.ygyno.2008.01.023. Epub 2008 Mar 4.
PubMed 18304622
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.
PubMed 20839058
Diaz-Feijoo B, Gil-Ibanez B, Perez-Benavente A, Martinez-Gomez X, Colas E, Sanchez-Iglesias JL, Cabrera-Diaz S, Puig-Puig O, Magrina JF, Gil-Moreno A. Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy. Gynecol Oncol. 2014 Jan;132(1):98-101. doi: 10.1016/j.ygyno.2013.11.004. Epub 2013 Nov 11.
PubMed 24231134
Bebia V, Gil-Moreno A, Hernandez A, Gilabert-Estelles J, Franco-Camps S, de la Torre J, Siegrist J, Chipirliu A, Cabrera S, Bradbury M, Perez-Benavente A, Diaz-Feijoo B. Robot-assisted Extraperitoneal Para-aortic Lymphadenectomy Is Associated with Fewer Surgical Complications: A Post Hoc Analysis of the STELLA-2 Randomized Trial. J Minim Invasive Gynecol. 2021 Dec;28(12):2004-2012.e1. doi: 10.1016/j.jmig.2021.05.009. Epub 2021 May 20.
PubMed 34022445
Diaz-Feijoo B, Bebia V, Hernandez A, Gilabert-Estalles J, Franco-Camps S, de la Torre J, Segrist J, Chipirliu A, Cabrera S, Perez-Benavente A, Gil-Moreno A. Surgical complications comparing extraperitoneal vs transperitoneal laparoscopic aortic staging in early stage ovarian and endometrial cancer. Gynecol Oncol. 2021 Jan;160(1):83-90. doi: 10.1016/j.ygyno.2020.10.038. Epub 2020 Nov 5.
PubMed 33160695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
Active, not recruitingPhase 2
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
Carcinoma

All Endometrial Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications
ClinicalTrials.gov ID: NCT02676726
Acronym / sponsor ID: STELLA-2 / P14/1817
Conditions: Endometrial Neoplasms, Ovarian Neoplasms
Keywords: extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial cancer, ovarian cancer, surgical staging
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
Collaborators: European Regional Development Fund
Study start: Jul 2014 (actual)
Primary completion: Sep 2019 (actual)
Study completion: 8 Sep 2019 (actual)
First posted: 8 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Extraperitoneal	Experimental	Procedure: Extraperitoneal Laparoscopic aortic lymphadenectomyPatients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
Transperitoneal	Active comparator	Procedure: Transperitoneal Laparoscopic aortic lymphadenectomyPatients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Who may qualify

Ages: 18 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extraperitoneal Laparoscopic aortic lymphadenectomyAlso: Extraperitoneal laparoscopic para-aortic lymphadenectomy, Retroperitoneal laparoscopic lumbo-aortic lymphadenectomyAortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.	Procedure or surgery	Extraperitoneal
Transperitoneal Laparoscopic aortic lymphadenectomyAlso: Transperitoneal laparoscopic para-aortic lymphadenectomy, Transperitoneal laparoscopic lumbo-aortic lymphadenectomyAortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.	Procedure or surgery	Transperitoneal

Primary outcome

Surgical complications
Time frame: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery
Composite outcome defined by including at least one of the following: * Total estimated blood loss > 500 mL during surgery * Blood transfusion * Intraoperative complication classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Early postoperative complication (within 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Late postoperative complication (past 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Conversion to laparotomy during the aortic lymphadenectomy * Inability to complete the aortic lymphadenectomy

5 secondary outcomes

Number of lymph nodes
Time frame: Postoperatively (within 1 week), at the moment of histopathologic examination
Operative time
Time frame: At the time of the surgery
Hospital stay
Time frame: Measured the day the patient is discharged (up to 100 days)
Overall survival
Time frame: up to 3 years after surgery
Disease-free survival
Time frame: up to 3 years after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
Background: PubMed 8641608Vasilev SA, McGonigle KF. Extraperitoneal laparoscopic para-aortic lymph node dissection. Gynecol Oncol. 1996 Jun;61(3):315-20. doi: 10.1006/gyno.1996.0149.
Background: PubMed 18835020Dowdy 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.
Background: PubMed 18365538Gil-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.
Background: PubMed 16431320Gil-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.
Background: PubMed 18538379Gil-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.
Background: PubMed 18607826Gil-Moreno A, Franco-Camps S, Diaz-Feijoo B, Perez-Benavente A, Martinez-Palones JM, Del Campo JM, Parera M, Verges R, Castellvi J, Xercavins J. Usefulness of extraperitoneal laparoscopic paraaortic lymphadenectomy for lymph node recurrence in gynecologic malignancy. Acta Obstet Gynecol Scand. 2008;87(7):723-30. doi: 10.1080/00016340802136343.
Background: PubMed 24361579Pakish J, Soliman PT, Frumovitz M, Westin SN, Schmeler KM, Reis RD, Munsell MF, Ramirez PT. A comparison of extraperitoneal versus transperitoneal laparoscopic or robotic para-aortic lymphadenectomy for staging of endometrial carcinoma. Gynecol Oncol. 2014 Feb;132(2):366-71. doi: 10.1016/j.ygyno.2013.12.019. Epub 2013 Dec 20.
Background: PubMed 20188409Dowdy SC, Mariani A. Lymphadenectomy in endometrial cancer: when, not if. Lancet. 2010 Apr 3;375(9721):1138-40. doi: 10.1016/S0140-6736(09)62068-7. Epub 2010 Feb 24. No abstract available.
Background: PubMed 18304622Mariani A, Dowdy SC, Cliby WA, Gostout BS, Jones MB, Wilson TO, Podratz KC. Prospective assessment of lymphatic dissemination in endometrial cancer: a paradigm shift in surgical staging. Gynecol Oncol. 2008 Apr;109(1):11-8. doi: 10.1016/j.ygyno.2008.01.023. Epub 2008 Mar 4.
Background: PubMed 20839058Gil-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.
Background: PubMed 24231134Diaz-Feijoo B, Gil-Ibanez B, Perez-Benavente A, Martinez-Gomez X, Colas E, Sanchez-Iglesias JL, Cabrera-Diaz S, Puig-Puig O, Magrina JF, Gil-Moreno A. Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy. Gynecol Oncol. 2014 Jan;132(1):98-101. doi: 10.1016/j.ygyno.2013.11.004. Epub 2013 Nov 11.
Derived from this study: PubMed 34022445Bebia V, Gil-Moreno A, Hernandez A, Gilabert-Estelles J, Franco-Camps S, de la Torre J, Siegrist J, Chipirliu A, Cabrera S, Bradbury M, Perez-Benavente A, Diaz-Feijoo B. Robot-assisted Extraperitoneal Para-aortic Lymphadenectomy Is Associated with Fewer Surgical Complications: A Post Hoc Analysis of the STELLA-2 Randomized Trial. J Minim Invasive Gynecol. 2021 Dec;28(12):2004-2012.e1. doi: 10.1016/j.jmig.2021.05.009. Epub 2021 May 20.

Related trials for Endometrial Neoplasms

RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
Active, not recruitingPhase 2
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Gil Moreno, MD, PhD study chair

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Berta Diaz Feijoo, MD, PhD study director

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Alejandro Correa Paris, MD principal investigator

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical complications (time frame: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02676726, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.