- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03719547
Robot-assisted Approach to Cervical Cancer (RACC)
Study Overview
Status
Conditions
Detailed Description
BACKGROUND Cervical cancer is one of the most common female malignancies worldwide, with the largest proportion of women affected in low income countries. Radical hysterectomy with pelvic lymphadenectomy constitutes the primary treatment of early stage cervical cancer. Surgery has traditionally been performed by laparotomy but the past 20 years, the use of minimally invasive techniques has increased. Several studies suggest that laparoscopic radical hysterectomy is associated with less preoperative morbidity and superior quality of life.
In 2005, the Food and Drug Administration (FDA) approved robot-assisted surgery for gynaecological indications. Observational studies have confirmed advantages in form of shorter hospital stay, less bleeding and acceptable OT. Furthermore, compared to conventional laparoscopy OT is significantly shorter with robot technique. Despite wide acceptance and implementation of the robotic system into gynecological oncology todate there are mainly retrospective observational data published on oncological outcomes, offering a low evidence level.
The sentinel node biopsy concept (SNB) is well established in the surgical management of several malignancies including breast, melanoma and vulvar cancer. Theoretically, the implementation would change the management of patients with early cervical cancer dramatically by avoiding multimodal treatment.
Traditionally, radiotracers (Technetium) with or without augmentation of blue dye have been used for SNB. Novel tracers such as fluorescent dyes (indocyanine green (ICG)) have been demonstrated to be superior.
Apart from detection rate, the rate of bilateral mapping of sentinel nodes and sensitivity (false negative rate included), constitutes the most important aspect of the technique. In recent ESGO guidelines on the management of stage IA disease SNB is recommended as the standard treatment unless in patients with positive LVSI where complete PLND should be considered.
RATIONALE In 2018, the LACC (Laparoscopic Approach to Cervical Cancer) trial was completed and the results demonstrated inferiority for minimally invasive surgery (MIS). In the trial, 631 women were randomized to MIS (85% by traditional laparoscopy and the remaining by robot-assisted surgery). Disease-free and overall survival were significantly worse by MIS with no observed advantage in quality of life or perioperative morbidity.
After the trial was closed, two large population-based studies from the Nordic countries (unpublished data) show no difference in either DFS or OS. The absolute majority in these studies were operated by robot-assisted surgery.
Robot-assisted surgery has replaced traditional laparoscopy for radical hysterectomy. Whether robot-assisted surgery is associated with better oncologic outcomes than traditional laparoscopy is unknown.The purpose of the RACC trial is to assess the safety of robot-assisted laparoscopy for the surgical treatment of early stage cervical cancer.
RATIONALE FOR THE QUALITY OF LIFE ASSESSMENT Two randomised controlled trials (LAP2 and LACE) have demonstrated that MIS is superior to laparotomy i in terms of perioperative morbidity and quality of life. However, the LACC trial did not show any differences between MIS and laparotomy for these outcomes. Whether robot-assisted surgery offers superior outcomes is unknown. In the RACC trial, QoL will be assessed in both arms at 5 time points using the EORTC QLQ-CX24 form and the FSFI (Female Sexual Function Index).
RATIONALE FOR THE SENTINEL NODE ALGORITHM Tumor extension to pelvic lymph nodes is the most important prognostic factor in early stage cervical cancer. Traditionally, nodal assessment has been performed through systematic pelvic lymphadenectomy. Sentinel node concepts have been evaluated in several smaller studies but none with sufficient power to properly assess the diagnostic accuracy.
PRIMARY ENDPOINT
- Recurrence-free survival (RFS) at 60 months
SECONDARY ENDPOINTS
- Overall survival (OS) at 60 months
- Perioperative morbidity
- Quality of life
- Diagnostic accuracy of a sentinel node algorithm in cervical cancer
- Health care costs
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Annette Dahlberg
- Phone Number: +46 8 517 750 71
- Email: annette.dahlberg@sll.se
Study Locations
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Stockholm, Sweden, 17176
- Recruiting
- Karolinska University Hospital
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Contact:
- Henrik Falconer, MD, PhD
- Phone Number: +46707742146
- Email: henrik.falconer@karolinska.se
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Principal Investigator:
- Henrik Falconer, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix;
- Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual
- Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification)
- Patients with adequate bone marrow, renal and hepatic function
- ECOG Performance Status of 0, 1 or 2.
- Patient must be suitable candidates for surgery.
- Patients who have signed an approved Informed Consent
- Age 18 years or older
Exclusion Criteria:
- Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- FIGO stage II-IV (except IIA1)
- Patients with a history of pelvic or abdominal radiotherapy
- Patients who are pregnant
- Patients with contraindications to surgery
- Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or activity)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Robot-assisted radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
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Radical hysterectomy (type B or C according to the Querleu&Morrow classification) with pelvic lymphadenectomy
Other Names:
Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
Other Names:
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Active Comparator: Abdominal radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
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Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
Other Names:
Radical hysterectomy (type B or C according to the Querleu&Morrow classification) with pelvic lymphadenectomy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence-free survival
Time Frame: 60 months from surgery
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Time-interval between the date of randomisation and the date of recurrence or the date of death
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60 months from surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 60 months from surgery
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Time-interval from the date of randomisation to the date of death (due to any cause), or for patients still alive to the date of last clinical follow-up or contact
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60 months from surgery
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Intraoperative complications: number of participants with bowel injuries, urinary tract injuries, hemorrhage requiring vessel suture and/or transfusion, nerve injuries
Time Frame: Complications occurring during intervention (intraoperatively)
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Assessed according to CLASSIC classification and Kaafarani et al.
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Complications occurring during intervention (intraoperatively)
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Post-operative complications: Number of participants requiring pharmacological treatment (CD II) OR surgical, endoscopic or radiological intervention (CD III) OR life-threatening complications requiring ICU-management (CD IV) OR death (CD V)
Time Frame: Postoperative complications are assessed at 30 days postoperatively and at 6 months postoperatively
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Assessed according to the Clavien-Dindo (CD) classification
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Postoperative complications are assessed at 30 days postoperatively and at 6 months postoperatively
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Health-related quality of life (HRQoL) after surgery for early stage cervical cancer using European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients (EORTC-QLQ).
Time Frame: Before randomisation, 1 month post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery, 60 months post surgery
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The response format for the EORTC QLQ is on a four-point scale, from 1 (Not at all) to 4 (Very much).
A high score on the functional scales and global quality of life represents a high level of functioning and quality of life.
A high score on the symptom scales/items represents a high level of symptoms.
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Before randomisation, 1 month post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery, 60 months post surgery
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Sentinel lymph node biopsy in cervical cancer
Time Frame: Through study completion, an average of 5 years
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Feasibility of a SLN algorithm: mapping of afferent lymphatic pathways from the cervix to the juxtauterine lymph node.
ICG or Technetium99 will be used as tracers.The algorithm comprises removal of suspicious nodes and ultrastaging of sentinel nodes
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Through study completion, an average of 5 years
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Health care costs
Time Frame: 6 months from surgery
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Total health care costs including surgical equipment, capital costs, pharmaceuticals, hospitalisation and costs related to re-admission to hospital.
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6 months from surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henrik Falconer, PhD, Karolinska University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- KS_RACC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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