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International radical trachelectomy assessment: IRTA study
G. Salvo, PT. Ramirez, M. Leitao, D. Cibula, C. Fotopoulou, A. Kucukmetin, G. Rendon, M. Perrotta, R. Ribeiro, M. Vieira, G. Baiocchi, H. Falconer, J. Persson, X. Wu, ME. Căpilna, N. Ioanid, BJ. Mosgaard, I. Berlev, D. Kaidarova, AB. Olawaiye, K....
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, multicentrická studie
NLK
ProQuest Central
od 2001-01-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 2001-01-01 do Před 6 měsíci
PubMed
30765489
DOI
10.1136/ijgc-2019-000273
Knihovny.cz E-zdroje
- MeSH
- lidé MeSH
- miniinvazivní chirurgické výkony metody MeSH
- nádory děložního čípku patologie chirurgie MeSH
- přežití po terapii bez příznaků nemoci MeSH
- retrospektivní studie MeSH
- roboticky asistované výkony metody MeSH
- staging nádorů MeSH
- trachelektomie metody MeSH
- zachování plodnosti metody MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
BACKGROUND: Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy. PRIMARY OBJECTIVE: To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy. STUDY HYPOTHESIS: We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach. STUDY DESIGN: This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data. INCLUSION CRITERIA: Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both). EXCLUSION CRITERIA: Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach. PRIMARY ENDPOINT: The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy. SAMPLE SIZE: An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.
A C Camargo Cancer Center São Paulo Brazil
Copenhagen University Hospital Rigshospitalet Copenhagen Denmark
Department of Gynecologic Oncology Imperial College London London UK
Fudan University Shanghai Cancer Center Shanghai China
General University Hospital Prague 1st Faculty of Medicine Charles University Prague Czech Republic
Ginecologia y Obstetricia Hospital Italiano de Buenos Aires Buenos Aires Argentina
Gynecologic Oncology UPMC Pittsburgh USA
Hospital de Cancer de Barretos Barretos Brazil
Instituto de Cancerologia de las Americas Medellin Colombia
IOP Instituto de Oncologia do Parana Curitiba Brazil Hospital Erasto Gaertner Curitiba Brazil
Karolinska Institutet Stockholm Sweden
Kazahskij naucno issledovatel'skij institut onkologii i radiologii Almaty Kazakhstan
Memorial Sloan Kettering Cancer Center New York USA
Oncological surgery Clinica Astorga Envigado Colombia Instituto Nacional del Cancer Bogota Colombia
Queen Elizabeth Hospital Gateshead UK
RenJi Hospital affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China
Citace poskytuje Crossref.org
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