Conservative Surgery for Women With Cervical Cancer

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-008148
    NCT ID: NCT01048853
    Sponsor Protocol Number: 2008-0118

About this study

The goal of this surgical research study is to learn if conservative surgery is a safe and feasible option for women with low-risk cervical cancer (stage IA2 or IB1, Grade 1 or 2).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  1. Squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix
  2. FIGO stage IA2 or IB1 disease
  3. Tumor diameter ≤ 2 cm on physical exam & imaging studies (if performed)
  4. No lymphovascular space invasion present on biopsy or previous cone
  5. Less than 10mm of cervical stromal invasion
  6. Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) CIN II, CIN III or adenocarcinoma-in-situ (A negative margin is defined as no invasive cancer within 5.0mm of the margin and no AIS or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted)
  7. Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met. The cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study. If the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria.
  8. Patients must sign approved ICD
  9. If patient is of childbearing potential, must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study.
  10. Patients who have had a simple hysterectomy (cut-through hysterectomy) prior to enrollment are eligible, provided the above pathology criteria are met. If lymphadenectomy was performed the lymph nodes must be negative. If lymphadenectomy was not performed, patients will undergo this procedure as part of the study.

Exclusion Criteria:

  1. Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies
  2. Grade 3 adenocarcinoma
  3. FIGO stage IA1, IB2, II, III or IV disease
  4. Tumors >2 cm in diameter on physical exam or imaging studies (if performed)
  5. Presence of LVSI
  6. Greater than or equal to 10mm of cervical stromal invasion
  7. Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted)
  8. Neoadjuvant radiation therapy or chemotherapy for cervical cancer
  9. Patients unwilling or unable to provide informed consent for the study

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sean Dowdy, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20141841

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