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

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

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)

Study Overview

• Status: Unknown
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Procedure: RADICAL HYSTERECTOMY

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

1. Only centers belonging to the ESGO area can participate in the study
2. 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
3. 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.
4. 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).
5. For collecting data, the online questionnaire can be reached in the following link: https://forms.gle/H1hCqXoC7G2EdWc79
6. 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.
7. Investigators want to complete the data collection in less than six months.
8. The principal investigator will be available for any doubt by e-mail (lchiva@unav.es), or also by phone (+34630232947)
9. 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Luis M Chiva, MD, PhD; Phone Number: +34630232947; Email: lchiva@unav.es
• Study Contact Backup: Name: Daniel Vazquez, MD, PhD; Phone Number: 649357901; Email: dvazquezv@unav.es

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival at 4.5 years	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Overall survival at 5 years between groups.	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.	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
Patterns of recurrence	Compare patterns of recurrence between groups.	Through study completion, an average of 1 year
Rate of surgical complications during the first 30 days after surgery	Compare treatment-associated morbidity (30 days after surgery ) between groups	30 days after surgery

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: 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 and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Anticipated): December 15, 2019
• Study Completion (Anticipated): December 15, 2019

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: SUCCOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: It will be uploaded in the network and it will be reached by a link provided by the promotors
• IPD Sharing Time Frame: January 2020
• IPD Sharing Access Criteria: It will be necessary to send an official request to the promotors
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No