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Gentler surgery for cervical cancer shows promise, study halted early

NCT ID NCT01048853

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a less invasive surgery (conservative surgery) could safely treat women with early-stage, low-risk cervical cancer. The goal was to see if this approach causes fewer side effects and helps recovery. The study included 137 women with stage IA2 or IB1 cervical cancer and was stopped early, but the results help guide future treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

137 people

The number who actually took part.

Started

Apr 2010

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix * International Federation of Gynecology and Obstetrics (FIGO) stage IA2 or IB1 disease * Tumor diameter =\< 2 cm on physical exam and on imaging studies * No lymphovascular space invasion (LVSI) present on biopsy or previous cone * Less than 10 mm of cervical stromal invasion * Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) II, CIN III or adenocarcinoma-in-situ; (a negative margin is defined as no invasive cancer within 1.0 mm of both the endocervical and ectocervical margins and no adenocarcinoma in situ \[AIS\] or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted) * 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 * Patients must sign an approved informed consent document * If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study * Imaging with positron emission tomography (PET) scan, computed tomography (CT) scan of the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment Exclusion Criteria: * Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies * Grade 3 adenocarcinoma * FIGO stage IA1, IB2, II, III or IV disease * Tumors \> 2 cm in diameter on physical exam or imaging studies * Presence of LVSI * Greater than or equal to 10 mm of cervical stromal invasion * Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted) * Neoadjuvant radiation therapy or chemotherapy for cervical cancer * Patients unwilling or unable to provide informed consent for the study * Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment * Patients who have had a simple hysterectomy (cut through hysterectomy)

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Conditions

The condition(s) this trial relates to.

cervical adenocarcinoma cervical squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical adenocarcinoma Cervical squamous cell carcinoma, not otherwise specified Stage IA2 cervical cancer ajcc V6 and V7 Stage IB1 cervical cancer ajcc V6 and V7

Contacts and locations

Locations

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Hospital Israelita Buenos Aires

    Buenos Aires, 1407, Argentina

  • Hospital Italiano of Buenos Aires

    Buenos Aires, 1181, Argentina

  • Hosptial de Cancer de Barretos

    Barretos, São Paulo, 14784, Brazil

  • Instituto Nacional De Cancerologia

    Bogotá, 99999, Colombia

  • Instituto Nacional De Cancerologia de Mexico

    Mexico City, Tlalpan, 14080, Mexico

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34, Peru

  • Instituto de Oncologia Angel H Roffo

    Buenos Aires, 1417, Argentina

  • King Chulalongkorn University

    Bangkok, Pathumwan, 10330, Thailand

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • MD Anderson League City

    Nassau Bay, Texas, 77058, United States

  • MD Anderson in Katy

    Houston, Texas, 77094, United States

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478, United States

  • MD Anderson in The Woodlands

    The Woodlands, Texas, 77384, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706, United States

  • Royal Women's Hosptial

    Melbourne, Victoria, 3052, Australia

  • The Woman's Hospital of Texas

    Houston, Texas, 77054, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.