Clinical trial NCT01048853: Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
Official title: Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-14
Enrollment: 137
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: PRIMARY OBJECTIVE:

I. 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:

I. 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.

V. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of study treatment by determining the immediate failure rate, defined as residual disease in the sample hysterectomy specimen
timeFrame: Up to 7 days
measure: Recurrence rate
timeFrame: 2 years
measure: Short Form Health Survey SF-12 Questionnaires
timeFrame: Baseline up to 5 years
measure: Functional Assessment of Cancer Therapy-Cervix [FACT-CX] Questionnaires
timeFrame: Baseline up to 5 years
measure: MD Anderson Symptom Inventory MDASI Questionnaires
timeFrame: Baseline up to 5 years
measure: Female Sexual Functioning Index (FSFI) Questionnaires
timeFrame: Baseline up to 5 years
measure: Satisfaction with Decision(SWD)Scale Questionnaires
timeFrame: Baseline up to 5 years
measure: Proportion of patients identified with metastases present, micrometastases present, isolated tumor cells, and tumor absent in sentinel lymph nodes
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Voorhees
country: United States
facility: MD Anderson Cancer Center at Cooper-Voorhees
state: New Jersey
city: Bay Shore
country: United States
facility: Northwell Health Imbert Cancer Center
state: New York
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: Houston
country: United States
facility: MD Anderson in Katy
state: Texas
city: Nassau Bay
country: United States
facility: MD Anderson League City
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson in Sugar Land
state: Texas
city: The Woodlands
country: United States
facility: MD Anderson in The Woodlands
state: Texas
city: Buenos Aires
country: Argentina
facility: Hospital Italiano of Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Israelita Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Oncologia Angel H Roffo
city: Victoria
country: Australia
facility: Royal Women's Hosptial
state: Parkville
city: Barretos
country: Brazil
facility: Hosptial de Cancer de Barretos
state: Sao Paulo
city: Bogota
country: Colombia
facility: Instituto Nacional De Cancerologia
city: Mexico City
country: Mexico
facility: Instituto Nacional De Cancerologia de Mexico
state: Tlalpan
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Bangkok
country: Thailand
facility: King Chulalongkorn University
state: Pathumwan
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathleen M Schmeler
role: PRINCIPAL_INVESTIGATOR
References: