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. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03958305

Recruitment Status : Unknown

Verified April 2019 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was: Recruiting

First Posted : May 22, 2019

Last Update Posted : May 29, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Clinica Universidad de Navarra, Universidad de Navarra

Study Description

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

Show detailed description

Detailed Description:

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.

1.-Pecorelli, S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet 105, 103-104 (2009).

Investigators want to know if the different surgical approaches may influence patients' survival (DFI and OS). A recent randomized phase III clinical trial, the LACC trial, conducted by Dr. Pedro Ramirez, was recently published in the NEJM.https://www.nejm.org/doi/pdf/10.1056/NEJMoa1806395

The LACC trial ran at 33 centers in 12 countries, including six US centers. The study, randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. The study's primary endpoint was disease-free survival at 4.5 years. The results favored significantly open surgery.

Just after this report, the results from a second study by Dr. Jose Alejandro Rauh-Hain, that used observational data from the US National Cancer Database found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy.

Also, Dr. Daniel Jacob Margul et al. presented during the last ASCO meeting their results from the Premier Health Database and the US National Cancer Database showing among women with >2 cm stage IB1 cervical cancer that MIS was associated with significantly decreased survival.

Likewise, these two studies have been as well published together along with the LACC trial in the same issue of NEJM.

In a recent survey conducted by the investigators and supported by ESGO, many of respondents showed the determination of collaborating in this observational project.

In Europe, it has not been recently not carried out any relevant large study comparing the different forms of surgical treatment of early cervical cancer.

The design of a randomized clinical trial in the coming years on this subject will face severe difficulties to convince ethics committees after the results of the last clinical trial.

Therefore, in the meantime, investigators consider it crucial to carry out a highly controlled European retrospective study that allows drawing satisfactory conclusions to make rational decisions on the treatment of early cervical cancer.

Investigators have selected a thorough list of inclusion and exclusion criteria along with a precise questionnaire trying to avoid confounding variables.

As you will realize, we will only include patients stage IB1(<4 cm, FIGO 2009), with preoperative MRI and with some requirements on the pathological report. For instance, patients that underwent conization are excluded.

HOW TO PARTICIPATE

Only centers belonging to the ESGO area can participate in the study
To accept the participation in the study as principal investigator (PI) of your institution (only one PI by each institution), the participant has to fill the application form included in the following link https://forms.gle/2WPhzrkxyFPodmDq5
As soon a center joins the study, the local PI will receive a Center Identification code and e-mail with instructions, allowing the data collection.
PI the will be allowed starting to collect data of consecutive cervical cancer patients operated in 2013 and 2014 in your center that meet the inclusion and exclusion criteria. (Appendix 2).
For collecting data, the online questionnaire can be reached in the following link: https://forms.gle/H1hCqXoC7G2EdWc79
Every time submit each a complete form, you will receive an e-mail with the confirmation and a copy of your response. For sending the form, you have to fill at least the required items. You are allowed to re-edit your answers later.
Investigators want to complete the data collection in less than six months.
The principal investigator will be available for any doubt by e-mail (lchiva@unav.es), or also by phone (+34630232947)
Besides, all the support documents will be sent to participants

PUBLICATIONS

The results of this study will be submitted for evaluation to international meetings and publication in a relevant international journal.

Authorship will include investigators following strict criteria, considering the introduced number of cases in the study by each investigator.

Furthermore, to count with as many authors as possible, researchers will create a Succor Research Study Group that will offer authorship when the investigators cannot allocate among the first authors

At the time of the publication, we will follow the STROBE guidelines for observational studies. (2) STROBE stands for an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and journal editors involved in the conduct and dissemination of observational studies, with the common aim of STrengthening the Reporting of OBservational studies in Epidemiology.

(2) von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9.

SUMMARY

The primary goal of the study is to know the outcomes of European patients that underwent radical surgery for stage IB1 cervical cancer (Open vs. MIS) during years 2013 and 2014.

Study Design

Layout table for study information

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

MedlinePlus related topics: Cervical Cancer Hysterectomy

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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

Contacts and Locations

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

Layout table for location contacts

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

Locations

Layout table for location information

Spain
Clinica Universidad de Navarra	Recruiting
Pamplona, Spain
Contact: Enrique Chiva, MD

Sponsors and Collaborators

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

Layout table for investigator information

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

More Information

Publications:

Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.

Layout table for additonal information

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

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Uterine Cervical Neoplasms 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

To Top