Cervical AdenocarcinomaNCT01048853
Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
A study testing Lymph Node Mapping, Quality-of-Life Assessment and Salpingo-Oophorectomy in people with Cervical Adenocarcinoma and Cervical Squamous Cell Carcinoma, Not Otherwise Specified, run by M.D. Anderson Cancer Center at 20 sites in 8 countries.
Trial summary
This clinical trial studies conservative surgery in treating patients with low-risk stage IA2 or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IA2 Cervical Cancer AJCC v6 and v7
- What is being tested?
- Lymph Node Mapping, Quality-of-Life Assessment and Salpingo-Oophorectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 15 Apr 2010to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
United States11 sites
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
M D Anderson Cancer Center
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77054
MD Anderson in Katy
Houston, Texas, 77094
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
MD Anderson League City
Nassau Bay, Texas, 77058
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
MD Anderson in The Woodlands
The Woodlands, Texas, 77384
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043
Argentina3 sites
Hospital Italiano of Buenos Aires
Buenos Aires, 1181
Hospital Israelita Buenos Aires
Buenos Aires, 1407
Instituto de Oncologia Angel H Roffo
Buenos Aires, 1417
Mexico1 site
Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, 14080
About this study
Official title: Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
This clinical trial studies conservative surgery in treating patients with low-risk stage IA2 or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features.
SECONDARY OBJECTIVES:
- To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features.
II. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy.
III. To estimate the sensitivity of sentinel lymph node biopsy in the determination of pelvic lymph node metastases in this group of patients.
IV. To compare the treatment-associated morbidity in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy.
- To assess quality of life factors, sexual functioning, symptoms and satisfaction with healthcare decisions in this group of patients.
OUTLINE:
Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
After completion of study treatment, patients are followed up every 3 months for 2 years and then yearly for 3 years.
- Conditions
- 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
- Being tested
- Lymph Node Mapping, Quality-of-Life Assessment, Salpingo-Oophorectomy, Sentinel Lymph Node Biopsy, Therapeutic Conventional Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph Node MappingProcedure or surgery
Also called lymphatic mapping
Undergo lymphatic mapping with sentinel lymph node biopsy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Salpingo-OophorectomyProcedure or surgery
Undergo hysterectomy with or without salpingo-oophorectomy
Sentinel Lymph Node BiopsyProcedure or surgery
Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo lymphatic mapping with sentinel lymph node biopsy
Therapeutic Conventional SurgeryProcedure or surgery
Undergo hysterectomy with or without salpingo-oophorectomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (conservative surgery) | Experimental | Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy. Receives: Procedure: Lymph Node Mapping; Other: Quality-of-Life Assessment; Procedure: Salpingo-Oophorectomy; Procedure: Sentinel Lymph Node Biopsy; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%. The immediate failure rate, defined as residual disease in the simple hysterectomy specimen of women who underwent conization followed by simple hysterectomy and lymph node assessment.
Measured: Approximately 9 years
Secondary outcomes (2)
Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
Recurrence rate was estimated and was measured from the date of surgery to the earliest date of the last clinic visit, date of first recurrence, or date of death.
Measured: 2 years
Number of Participants With All-Cause Mortality
Total patient morbidity within 30 days following conservative surgery
Measured: Approximately 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study start15 Apr 2010
- Primary completion31 Dec 2024
- Study completion5 Dec 2025
Why it stopped: \< 75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathleen M Schmeler, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048853
- Sponsor's protocol ID
- 2008-0118
- Other IDs
- NCI-2012-01254, 2008-0118
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2010
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
- ClinicalTrials.gov ID
- NCT01048853
- Acronym / sponsor ID
- 2008-0118
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \< 75% participation
- Enrolment
- 137 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Apr 2010 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies conservative surgery in treating patients with low-risk stage IA2 or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features.
SECONDARY OBJECTIVES:
- To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features.
II. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy.
III. To estimate the sensitivity of sentinel lymph node biopsy in the determination of pelvic lymph node metastases in this group of patients.
IV. To compare the treatment-associated morbidity in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy.
- To assess quality of life factors, sexual functioning, symptoms and satisfaction with healthcare decisions in this group of patients.
OUTLINE:
Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
After completion of study treatment, patients are followed up every 3 months for 2 years and then yearly for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (conservative surgery) | Experimental | Procedure: Lymph Node Mapping, Other: Quality-of-Life Assessment, Procedure: Salpingo-Oophorectomy, Procedure: Sentinel Lymph Node Biopsy, Procedure: Therapeutic Conventional SurgeryPatients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymph Node MappingAlso: lymphatic mappingUndergo lymphatic mapping with sentinel lymph node biopsy | Procedure or surgery | Treatment (conservative surgery) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (conservative surgery) |
| Salpingo-OophorectomyUndergo hysterectomy with or without salpingo-oophorectomy | Procedure or surgery | Treatment (conservative surgery) |
| Sentinel Lymph Node BiopsyAlso: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo lymphatic mapping with sentinel lymph node biopsy | Procedure or surgery | Treatment (conservative surgery) |
| Therapeutic Conventional SurgeryUndergo hysterectomy with or without salpingo-oophorectomy | Procedure or surgery | Treatment (conservative surgery) |
Primary outcome
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
Time frame: Approximately 9 years
The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%. The immediate failure rate, defined as residual disease in the simple hysterectomy specimen of women who underwent conization followed by simple hysterectomy and lymph node assessment.
2 secondary outcomes
Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
Time frame: 2 years
Number of Participants With All-Cause Mortality
Time frame: Approximately 9 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Schmeler principal investigator
M.D. Anderson Cancer Center
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymph Node Mapping, Quality-of-Life Assessment and Salpingo-Oophorectomy in people with Cervical Adenocarcinoma and Cervical Squamous Cell Carcinoma, Not Otherwise Specified, run by M.D. Anderson Cancer Center at 20 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Argentina, Australia, Brazil, Colombia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features (time frame: Approximately 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.