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

Falconer, Henrik; Palsdottir, Kolbrun; Stalberg, Karin; Dahm-Kähler, Pernilla; Ottander, Ulrika; Lundin, Evelyn Serreyn; Wijk, Lena; Kimmig, Rainer; Jensen, Pernille Tine and Eriksson, Ane Gerda Zahl, et al. (2019) In International Journal of Gynecological Cancer 29(6). p.1072-1076
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,... (More)

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).

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published
subject
keywords
cervical cancer, surgical oncology
in
International Journal of Gynecological Cancer
volume
29
issue
6
pages
5 pages
publisher
Wiley-Blackwell
external identifiers
  • scopus:85068344066
ISSN
1048-891X
DOI
10.1136/ijgc-2019-000558
language
English
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yes
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6483bb96-8701-4479-a6a8-4e0cd63dd729
date added to LUP
2019-07-12 11:31:38
date last changed
2019-08-06 03:24:20
@article{6483bb96-8701-4479-a6a8-4e0cd63dd729,
  abstract     = {<p>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 &gt;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).</p>},
  author       = {Falconer, Henrik and Palsdottir, Kolbrun and Stalberg, Karin and Dahm-Kähler, Pernilla and Ottander, Ulrika and Lundin, Evelyn Serreyn and Wijk, Lena and Kimmig, Rainer and Jensen, Pernille Tine and Eriksson, Ane Gerda Zahl and Mäenpää, Johanna and Persson, Jan and Salehi, Sahar},
  issn         = {1048-891X},
  keyword      = {cervical cancer,surgical oncology},
  language     = {eng},
  month        = {07},
  number       = {6},
  pages        = {1072--1076},
  publisher    = {Wiley-Blackwell},
  series       = {International Journal of Gynecological Cancer},
  title        = {Robot-assisted approach to cervical cancer (RACC) : An international multi-center, open-label randomized controlled trial},
  url          = {http://dx.doi.org/10.1136/ijgc-2019-000558},
  volume       = {29},
  year         = {2019},
}