International radical trachelectomy assessment: IRTA study
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F19%3A10399751" target="_blank" >RIV/00064165:_____/19:10399751 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00216208:11110/19:10399751
Výsledek na webu
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=8f0Ir7a2qM" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=8f0Ir7a2qM</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1136/ijgc-2019-000273" target="_blank" >10.1136/ijgc-2019-000273</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
International radical trachelectomy assessment: IRTA study
Popis výsledku v původním jazyce
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.
Název v anglickém jazyce
International radical trachelectomy assessment: IRTA study
Popis výsledku anglicky
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.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30214 - Obstetrics and gynaecology
Návaznosti výsledku
Projekt
—
Návaznosti
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Ostatní
Rok uplatnění
2019
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
International Journal of Gynecological Cancer
ISSN
1048-891X
e-ISSN
—
Svazek periodika
29
Číslo periodika v rámci svazku
3
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
4
Strana od-do
635-638
Kód UT WoS článku
000471042900030
EID výsledku v databázi Scopus
2-s2.0-85062404354