Robot-assisted approach to cervical cancer (RACC): An international multi-center, open-label randomized controlled trial

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Standard

Robot-assisted approach to cervical cancer (RACC) : An international multi-center, open-label randomized controlled trial. / Falconer, Henrik; Palsdottir, Kolbrun; Stalberg, Karin et al.

I: International Journal of Gynecological Cancer, Bind 29, Nr. 6, 01.07.2019, s. 1072-1076.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

Harvard

Falconer, H, Palsdottir, K, Stalberg, K, Dahm-Kähler, P, Ottander, U, Lundin, ES, Wijk, L, Kimmig, R, Jensen, PT, Eriksson, AGZ, Mäenpää, J, Persson, J & Salehi, S 2019, 'Robot-assisted approach to cervical cancer (RACC): An international multi-center, open-label randomized controlled trial', International Journal of Gynecological Cancer, bind 29, nr. 6, s. 1072-1076. https://doi.org/10.1136/ijgc-2019-000558

APA

Falconer, H., Palsdottir, K., Stalberg, K., Dahm-Kähler, P., Ottander, U., Lundin, E. S., Wijk, L., Kimmig, R., Jensen, P. T., Eriksson, A. G. Z., Mäenpää, J., Persson, J., & Salehi, S. (2019). Robot-assisted approach to cervical cancer (RACC): An international multi-center, open-label randomized controlled trial. International Journal of Gynecological Cancer, 29(6), 1072-1076. https://doi.org/10.1136/ijgc-2019-000558

CBE

Falconer H, Palsdottir K, Stalberg K, Dahm-Kähler P, Ottander U, Lundin ES, Wijk L, Kimmig R, Jensen PT, Eriksson AGZ, et al. 2019. Robot-assisted approach to cervical cancer (RACC): An international multi-center, open-label randomized controlled trial. International Journal of Gynecological Cancer. 29(6):1072-1076. https://doi.org/10.1136/ijgc-2019-000558

MLA

Vancouver

Falconer H, Palsdottir K, Stalberg K, Dahm-Kähler P, Ottander U, Lundin ES et al. Robot-assisted approach to cervical cancer (RACC): An international multi-center, open-label randomized controlled trial. International Journal of Gynecological Cancer. 2019 jul. 1;29(6):1072-1076. https://doi.org/10.1136/ijgc-2019-000558

Author

Falconer, Henrik ; Palsdottir, Kolbrun ; Stalberg, Karin et al. / Robot-assisted approach to cervical cancer (RACC) : An international multi-center, open-label randomized controlled trial. I: International Journal of Gynecological Cancer. 2019 ; Bind 29, Nr. 6. s. 1072-1076.

Bibtex

@article{fab38c5ad8eb4102b4e34754eef0d6e2,
title = "Robot-assisted approach to cervical cancer (RACC): An international multi-center, open-label randomized controlled trial",
abstract = "Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival. Primary Objective To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy. Study Hypothesis Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes. Trial Design Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden. Major Inclusion/Exclusion Criteria Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years. Primary Endpoint Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer. Sample Size The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients. Estimated Dates for Completing Accrual and Presenting Results Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter. Trial Registration The trial is registered at ClinicalTrials.gov (NCT03719547).",
keywords = "cervical cancer, surgical oncology",
author = "Henrik Falconer and Kolbrun Palsdottir and Karin Stalberg and Pernilla Dahm-K{\"a}hler and Ulrika Ottander and Lundin, {Evelyn Serreyn} and Lena Wijk and Rainer Kimmig and Jensen, {Pernille Tine} and Eriksson, {Ane Gerda Zahl} and Johanna M{\"a}enp{\"a}{\"a} and Jan Persson and Sahar Salehi",
year = "2019",
month = jul,
day = "1",
doi = "10.1136/ijgc-2019-000558",
language = "English",
volume = "29",
pages = "1072--1076",
journal = "International Journal of Gynecological Cancer",
issn = "1048-891X",
publisher = "Lippincott Williams & Wilkins, Ltd.",
number = "6",

}

RIS

TY - JOUR

T1 - Robot-assisted approach to cervical cancer (RACC)

T2 - An international multi-center, open-label randomized controlled trial

AU - Falconer, Henrik

AU - Palsdottir, Kolbrun

AU - Stalberg, Karin

AU - Dahm-Kähler, Pernilla

AU - Ottander, Ulrika

AU - Lundin, Evelyn Serreyn

AU - Wijk, Lena

AU - Kimmig, Rainer

AU - Jensen, Pernille Tine

AU - Eriksson, Ane Gerda Zahl

AU - Mäenpää, Johanna

AU - Persson, Jan

AU - Salehi, Sahar

PY - 2019/7/1

Y1 - 2019/7/1

N2 - Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival. Primary Objective To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy. Study Hypothesis Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes. Trial Design Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden. Major Inclusion/Exclusion Criteria Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years. Primary Endpoint Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer. Sample Size The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients. Estimated Dates for Completing Accrual and Presenting Results Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter. Trial Registration The trial is registered at ClinicalTrials.gov (NCT03719547).

AB - Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival. Primary Objective To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy. Study Hypothesis Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes. Trial Design Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden. Major Inclusion/Exclusion Criteria Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years. Primary Endpoint Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer. Sample Size The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients. Estimated Dates for Completing Accrual and Presenting Results Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter. Trial Registration The trial is registered at ClinicalTrials.gov (NCT03719547).

KW - cervical cancer

KW - surgical oncology

UR - http://www.scopus.com/inward/record.url?scp=85068344066&partnerID=8YFLogxK

U2 - 10.1136/ijgc-2019-000558

DO - 10.1136/ijgc-2019-000558

M3 - Journal article

C2 - 31203203

AN - SCOPUS:85068344066

VL - 29

SP - 1072

EP - 1076

JO - International Journal of Gynecological Cancer

JF - International Journal of Gynecological Cancer

SN - 1048-891X

IS - 6

ER -