Trial record 18 of 254 for:    hysterectomy

Radical Versus Simple Hysterectomy and Pelvic Node Dissection in Patients With Early Stage Cervical Cancer

This study is currently recruiting participants.
Verified February 2014 by NCIC Clinical Trials Group
Sponsor:
Collaborator:
Gynecologic Cancer Intergroup
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01658930
First received: August 3, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.


Condition Intervention Phase
Cervical Cancer
Procedure: Radical Hysterectomy
Procedure: Simple hysterectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-Risk Early Stage Cervical Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Pelvic relapse-free survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Pelvic relapse-free survival (PRFS), the primary endpoint of this study, is defined as the time from randomization to the time of documented evidence of recurrence within the pelvic field.


Secondary Outcome Measures:
  • Efficacy comparison between treatment arms [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

    compare the two treatment arms with respect to:

    • Extrapelvic relapse-free survival
    • Relapse-free survival (any site)
    • Overall survival
    • Treatment-related toxicity
    • Patient Reported Outcomes including global quality of life and measures of sexual health
    • Cost-effectiveness and cost-utility
    • Sentinel node detection
    • Parametrial involvement
    • Involvement of surgical margins
    • Pelvic node involvement


Estimated Enrollment: 700
Study Start Date: September 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radical Hysterectomy Procedure: Radical Hysterectomy
This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
Experimental: Simple Hysterectomy Procedure: Simple hysterectomy
This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.

Detailed Description:

At this time, it is not clear which of these approaches best balances the desire to prevent cancer of the cervix from returning with the risks of side effects after surgery and in the long-term.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist.
  • Patient has been classified as low-risk early-stage cervical cancer. These patients include:

    • FIGO Stage IA2 [FIGO Annual Report, 2009], defined as:

      • evidence of disease by microscopy;

        1. for patients who underwent a LEEP or cone.

          • histologic evidence of depth of stromal invasion between 3.0-5.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen.
          • histologic evidence of lateral extension that is not greater than 7.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen.
          • negative margins.
        2. for patients who underwent a cervical biopsy only:

          • radiologic evidence of less than 50% stromal invasion based on pelvic MRI.
    • FIGO Stage IB1 [FIGO Annual Report, 2009] with favorable (low risk) features, defined as:

      • a clinically visible lesion or a microscopically diagnosed lesion measuring > 5 mm depth of invasion or > 7 mm in lateral extension or a IA2 sized lesion with positive margins.
      • histologic evidence of less than 10mm stromal invasion based on the local reference pathologist's measurement of the LEEP or cone specimen Note: this criterion will not apply to patients who underwent a cervical biopsy only;
      • Radiologic evidence of maximum dimension of ≤ 20 mm as seen by pelvic MRI; and
      • Radiologic evidence of less than 50% stromal invasion based on pelvic MRI. Note: Patients are eligible irrespective of the presence or absence of lymph-vascular space involvement (LVSI).
  • The histologic grade of cervical cancer must be 1, 2, 3 or not assessable [FIGO Annual Report, 2009].
  • Physical examination, recto-vaginal examination and visualization of the cervix by speculum or colposcopic examination have been done after the initial diagnostic procedure (LEEP, cone or biopsy) and prior to randomization. Staging criteria described in 5.1.2 must be satisfied based on these examinations.
  • Chest x-ray or CT scan of chest AND pelvic MRI* done after initial diagnostic procedure (LEEP, cone or biopsy) and prior to randomization.

The CT should be a 16 slice (or higher) helical scanner. Oral and intravenous contrasts are required (unless there is a contraindication to the use of contrast) with scan obtained in the portal phase at a slice thickness of 5mm or lower Pelvic MRI should be performed on a 1.5 or 3 Tesla magnet with pelvic phased-array coils. The MR pulse sequences will consist of T1 gradient echo in the axial plane at 5 mm slice thickness and fast spin echo in the axial, sagittal, and coronal planes at 4 mm slice thickness. The short axis (perpendicular to the tumour's long axis) with a 3 mm slice thickness is required in the best plane to show the maximum thickness of stromal invasion. Use of an anti-peristaltic agent is mandatory while intravenous use of gadolinium or diffusion-weighted imaging (DWI) is optional.

* Note: pelvic MRI is not required if the patient has stage IA2 disease and underwent a LEEP or cone.

  • After consideration of a patient's medical history, physical examination and laboratory testing, patients must be suitable candidates for surgery as defined by the attending physician / investigator.
  • Patients must have no desire to preserve fertility.
  • Patients fluent in English, French or Spanish must be willing to complete the Quality of Life Questionnaire and the Sexual Health Questionnaire. The baseline assessments must be completed within 6 weeks prior to randomization. Inability (illiteracy in English, French or Spanish, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. As additional GCIG groups join the study, more translations of some of the questionnaires may be added.

Patients fluent in English or French who reside in Canada and the United Kingdom must agree to participate in the economic evaluation component of this trial and complete the Health Economics Questionnaire. Similarly, patients fluent in English or French accrued from other GCIG groups who are participating in the economic evaluation must be willing to complete the Health Economics Questionnaires.

  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • Surgery is to be done within 20 weeks of initial diagnosis (NO EXCEPTIONS). The 20-week period includes time required for diagnosis, referral, diagnostic staging, randomization and scheduling of the surgical procedure.
  • Patients must be ≥ 18 years old.

Exclusion Criteria:

  • Patients with FIGO 1A1 disease [FIGO Annual Report, 2009].
  • History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin's lymphoma or non-Hodgkin's lymphoma curatively treated with no evidence of disease for > 5 years.
  • Patients with evidence of lymph node metastasis on preoperative imaging or histology.
  • Patients who have had or will receive neoadjuvant chemotherapy.
  • Patients who are pregnant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658930

Contacts
Contact: Elizabeth Eisenhauer 6135336430 eeisenhauer@ctg.queensu.ca

Locations
Canada, Quebec
McGill University Dept of Oncology Recruiting
Montreal, Quebec, Canada, H2W 1S6
CHUQ-Pavillon Hotel-Dieu de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
NCIC Clinical Trials Group
Gynecologic Cancer Intergroup
Investigators
Study Chair: Marie Plante CHUQ - Hotel-Dieu de Quebec
  More Information

No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01658930     History of Changes
Other Study ID Numbers: CX5
Study First Received: August 3, 2012
Last Updated: February 4, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 22, 2014