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Robot-assisted Approach to Cervical Cancer (RACC)

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ClinicalTrials.gov Identifier: NCT03719547
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Henrik Falconer, Karolinska Institutet

Brief Summary:
The purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of early stage cervical cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: Abdominal radical hysterectomy Procedure: Robot-assisted radical hysterectomy Diagnostic Test: Sentinel lymph node biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot-assisted Approach to Cervical Cancer
Estimated Study Start Date : March 28, 2019
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot-assisted radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
Procedure: Robot-assisted radical hysterectomy
Radical hysterectomy (type B or C according to the Querleu&Morrow classification) with pelvic lymphadenectomy
Other Names:
  • TRRH
  • Robotic radical hysterectomy

Diagnostic Test: Sentinel lymph node biopsy
Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
Other Name: SLN

Active Comparator: Abdominal radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
Procedure: Abdominal radical hysterectomy
Radical hysterectomy (type B or C according to the Querleu&Morrow classification) with pelvic lymphadenectomy
Other Names:
  • TARH
  • Open radical hysterectomy

Diagnostic Test: Sentinel lymph node biopsy
Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
Other Name: SLN




Primary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 60 months from surgery ]
    Time-interval between the date of randomisation and the date of recurrence or the date of death


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 60 months from surgery ]
    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

  2. 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) ]
    Assessed according to CLASSIC classification and Kaafarani et al.

  3. 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 ]
    Assessed according to the Clavien-Dindo (CD) classification

  4. 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 ]
    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.

  5. Sentinel lymph node biopsy in cervical cancer [ Time Frame: Through study completion, an average of 5 years ]
    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

  6. Health care costs [ Time Frame: 6 months from surgery ]
    Total health care costs including surgical equipment, capital costs, pharmaceuticals, hospitalisation and costs related to re-admission to hospital.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719547


Contacts
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Contact: Annette Dahlberg +46 8 517 750 71 annette.dahlberg@sll.se

Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Henrik Falconer, PhD Karolinska University Hospital

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Responsible Party: Henrik Falconer, Head of GYN Oncology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03719547     History of Changes
Other Study ID Numbers: KS_RACC
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Henrik Falconer, Karolinska Institutet:
Cervical cancer
Robot-assisted surgery
Sentinel node biopsy
Laparotomy
Recurrence
Survival

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female