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