Clinical trial · Interventional
Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
NCT01048853CI-TRIAL-00100290terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): \< 75% participation
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IA2 Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IB1 Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymph Node Mapping | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Salpingo-Oophorectomy | Procedure | — | UNRESOLVED |
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (conservative surgery)
- description
- 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.
- interventionNames
- Procedure: Lymph Node Mapping
- Other: Quality-of-Life Assessment
- Procedure: Salpingo-Oophorectomy
- Procedure: Sentinel Lymph Node Biopsy
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
- timeFrame
- Approximately 9 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.