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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01048853




Registration number
NCT01048853
Ethics application status
Date submitted
12/01/2010
Date registered
14/01/2010
Date last updated
16/10/2024

Titles & IDs
Public title
Conservative Surgery in Treating Patients with Low-Risk Stage IA2 or IB1 Cervical Cancer
Scientific title
Conservative Surgery for Women with Low-Risk, Early Stage Cervical Cancer
Secondary ID [1] 0 0
NCI-2012-01254
Secondary ID [2] 0 0
2008-0118
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Adenocarcinoma 0 0
Cervical Squamous Cell Carcinoma, Not Otherwise Specified 0 0
Stage IA2 Cervical Cancer AJCC V6 and V7 0 0
Stage IB1 Cervical Cancer AJCC V6 and V7 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Lymph Node Mapping
Other interventions - Quality-of-Life Assessment
Treatment: Surgery - Salpingo-Oophorectomy
Treatment: Surgery - Sentinel Lymph Node Biopsy
Treatment: Surgery - Therapeutic Conventional Surgery

Experimental: Treatment (conservative surgery) - 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.


Treatment: Surgery: Lymph Node Mapping
Undergo lymphatic mapping with sentinel lymph node biopsy

Other interventions: Quality-of-Life Assessment
Ancillary studies

Treatment: Surgery: Salpingo-Oophorectomy
Undergo hysterectomy with or without salpingo-oophorectomy

Treatment: Surgery: Sentinel Lymph Node Biopsy
Undergo lymphatic mapping with sentinel lymph node biopsy

Treatment: Surgery: Therapeutic Conventional Surgery
Undergo hysterectomy with or without salpingo-oophorectomy
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of study treatment by determining the immediate failure rate, defined as residual disease in the sample hysterectomy specimen
Timepoint [1] 0 0
Up to 7 days
Primary outcome [2] 0 0
Recurrence rate
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Short Form Health Survey SF-12 Questionnaires
Timepoint [3] 0 0
Baseline up to 5 years
Primary outcome [4] 0 0
Functional Assessment of Cancer Therapy-Cervix [FACT-CX] Questionnaires
Timepoint [4] 0 0
Baseline up to 5 years
Primary outcome [5] 0 0
MD Anderson Symptom Inventory MDASI Questionnaires
Timepoint [5] 0 0
Baseline up to 5 years
Primary outcome [6] 0 0
Female Sexual Functioning Index (FSFI) Questionnaires
Timepoint [6] 0 0
Baseline up to 5 years
Primary outcome [7] 0 0
Satisfaction with Decision(SWD)Scale Questionnaires
Timepoint [7] 0 0
Baseline up to 5 years
Primary outcome [8] 0 0
Proportion of patients identified with metastases present, micrometastases present, isolated tumor cells, and tumor absent in sentinel lymph nodes
Timepoint [8] 0 0
Up to 5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
Parkvill
Recruitment hospital [1] 0 0
Royal Women's Hosptial - Victoria
Recruitment postcode(s) [1] 0 0
3052 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Colombia
State/province [8] 0 0
Bogota
Country [9] 0 0
Mexico
State/province [9] 0 0
Tlalpan
Country [10] 0 0
Peru
State/province [10] 0 0
Lima
Country [11] 0 0
Thailand
State/province [11] 0 0
Pathumwan

Funding & Sponsors
Primary sponsor type
Other
Name
M.D. Anderson Cancer Center
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01048853
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kathleen M Schmeler
Address 0 0
M.D. Anderson Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01048853