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SUCCOR-Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03958305
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary:
SUCCOR study tries to understand the outcomes of European patients with stage IB1 cervical cancer (FIGO 2009)1, that underwent a radical hysterectomy for cervical cancer in 2013-2014 within the ESGO area (European Society of Gynecologic Oncology)

Condition or disease Intervention/treatment
Uterine Cervical Neoplasms Procedure: RADICAL HYSTERECTOMY

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An International European Retrospective Cohort Observational Study Comparing Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Stage IB1 (FIGO 2009) Cervical Cancer Operated in 2013-2014
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LAPAROTOMY
Radical hysterectomy by laparotomy
Procedure: RADICAL HYSTERECTOMY
Radical hysterectomy is an operation done to treat some cancers of the cervix. The surgeon takes out the uterus and the ligaments (tissue fibers) that hold it in place. The cervix and an inch or 2 of the vagina around the cervix are also removed.

MINIMALLY INVASIVE SURGERY
Radical hysterectomy by minimally invasive surgery (Laparoscopy or Robotics)
Procedure: RADICAL HYSTERECTOMY
Radical hysterectomy is an operation done to treat some cancers of the cervix. The surgeon takes out the uterus and the ligaments (tissue fibers) that hold it in place. The cervix and an inch or 2 of the vagina around the cervix are also removed.




Primary Outcome Measures :
  1. Disease-free survival at 4.5 years [ Time Frame: From date of surgery for cervical cancer (Radical Hysterectomy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months ]
    Compare disease-free survival at 4.5 years in patients who underwent a laparoscopic or robotic radical hysterectomy (MIS) vs. abdominal radical hysterectomy (TARH) for stage IB1 cervical cancer.


Secondary Outcome Measures :
  1. Overall survival Overall survival at 5 years between groups. [ Time Frame: months until the date of first documented date of death from any cause or the date last contact if case patient is alive, assessed up to 84 months ]
    Compare overall survival at 5 years in patients who underwent a laparoscopic or robotic radical hysterectomy (MIS) vs. abdominal radical hysterectomy (TARH) for stage IB1 cervical cancer.

  2. Patterns of recurrence [ Time Frame: Through study completion, an average of 1 year ]
    Compare patterns of recurrence between groups.

  3. Rate of surgical complications during the first 30 days after surgery [ Time Frame: 30 days after surgery ]
    Compare treatment-associated morbidity (30 days after surgery ) between groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive participant sampling of patients with IB1 cervical cancer that underwent a Radical Hysterectomy plus pelvic lymphadenectomy by open or MIS
Criteria

Inclusion criteria

  • Primary squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
  • Stage IB1 carcinoma, <4 CMS, (FIGO 2009)
  • Preoperative pelvic MRI indicating tumor diameter < 4 cm (at least two dimensions,) and no parametrial invasion. Exceptionally it can be considered acceptable Vaginal Ultrasound, only if your Institution have internally validated this technique for cervical cancer. Otherwise it cannot be accepted.
  • Preoperative either (Abdominal) CT scan or MRI or PET-CT ruling out extracervical metastatic disease
  • Performance status ECOG 0-1
  • Age 18 years or older
  • Radical hysterectomy Type II-III or Type B-C by MIS (laparoscopic or robotic) or open surgery.
  • Patient was operated during the years 2013-2014 within the ESGO area.
  • Bilateral pelvic lymphadenectomy (+- sentinel LN biopsy)
  • Pathologic report shows information on tumor size, vaginal and parametrial margins and nodal status

Exclusion criteria

  • No past medical history of any invasive tumor
  • No previous abdominal or pelvic radiotherapy of any type (including braquitherapy).
  • No history of preoperative neoadjuvant chemotherapy .
  • No cervical conization previous to surgery
  • No suspicious positive pelvic or paraaortic nodes or metastatic disease on PET CT, MRI, or CT.
  • There is none uterine diameter larger than 12cm
  • No Conversion from MIS to laparotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958305


Contacts
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Contact: Luis M Chiva, MD, PhD +34630232947 lchiva@unav.es
Contact: Daniel Vazquez, MD, PhD 649357901 dvazquezv@unav.es

Locations
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Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Spain
Contact: Enrique Chiva, MD         
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Study Chair: Luis M Chiva, MD, PhD Clinica Universidad de Navarra
Study Director: Luis M Chiva, MD, PhD Clinica Universidad de Navarra
Principal Investigator: Daniel Vazquez, MD, PhD Clinica Universidad de Navarra
Principal Investigator: Jose A Minguez Clinica Universidad de Navarra
Publications:
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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT03958305    
Other Study ID Numbers: SUCCOR
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It will be uploaded in the network and it will be reached by a link provided by the promotors
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: January 2020
Access Criteria: It will be necessary to send an official request to the promotors

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female