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

NCT03958305UNKNOWNOBSERVATIONAL

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)

Key Facts

Lead Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Enrollment

1000

Start Date

2019-05-16

Completion Date

2019-12-15

Study Type

OBSERVATIONAL

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

Interventions

RADICAL HYSTERECTOMY

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Patterns of recurrence

Compare patterns of recurrence between groups.

Time frame: 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

Time frame: 30 days after surgery

Locations

Clinica Universidad de Navarra, Pamplona, Spain

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