Trial Outcomes & Findings for Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer (NCT NCT01048853)
NCT ID: NCT01048853
Last Updated: 2026-01-07
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
137 participants
Primary outcome timeframe
Approximately 9 years
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Fertility Sparing
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
Inadvertent simple hysterectomy followed by lymph node dissection
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
40
|
16
|
|
Overall Study
COMPLETED
|
42
|
36
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
Reasons for withdrawal
| Measure |
Fertility Sparing
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
Inadvertent simple hysterectomy followed by lymph node dissection
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
0
|
Baseline Characteristics
Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
Baseline characteristics by cohort
| Measure |
Fertility Sparing
n=44 Participants
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
n=40 Participants
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
n=16 Participants
Inadvertent simple hysterectomy followed by lymph node dissection
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=37 Participants
|
39 Participants
n=56 Participants
|
16 Participants
n=95 Participants
|
99 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=61 Participants
|
|
Age, Continuous
|
31 years
n=37 Participants
|
43 years
n=56 Participants
|
47 years
n=95 Participants
|
39 years
n=61 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=37 Participants
|
40 Participants
n=56 Participants
|
16 Participants
n=95 Participants
|
100 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=37 Participants
|
22 Participants
n=56 Participants
|
5 Participants
n=95 Participants
|
52 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=37 Participants
|
11 Participants
n=56 Participants
|
7 Participants
n=95 Participants
|
32 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
4 Participants
n=95 Participants
|
16 Participants
n=61 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
4 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
2 Participants
n=95 Participants
|
3 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=37 Participants
|
25 Participants
n=56 Participants
|
12 Participants
n=95 Participants
|
65 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=37 Participants
|
13 Participants
n=56 Participants
|
2 Participants
n=95 Participants
|
28 Participants
n=61 Participants
|
|
Region of Enrollment
Colombia
|
4 participants
n=37 Participants
|
8 participants
n=56 Participants
|
2 participants
n=95 Participants
|
14 participants
n=61 Participants
|
|
Region of Enrollment
Argentina
|
6 participants
n=37 Participants
|
1 participants
n=56 Participants
|
0 participants
n=95 Participants
|
7 participants
n=61 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=37 Participants
|
13 participants
n=56 Participants
|
10 participants
n=95 Participants
|
40 participants
n=61 Participants
|
|
Region of Enrollment
Brazil
|
10 participants
n=37 Participants
|
6 participants
n=56 Participants
|
3 participants
n=95 Participants
|
19 participants
n=61 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=37 Participants
|
3 participants
n=56 Participants
|
0 participants
n=95 Participants
|
4 participants
n=61 Participants
|
|
Region of Enrollment
Thailand
|
1 participants
n=37 Participants
|
0 participants
n=56 Participants
|
0 participants
n=95 Participants
|
1 participants
n=61 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=37 Participants
|
1 participants
n=56 Participants
|
0 participants
n=95 Participants
|
1 participants
n=61 Participants
|
|
Region of Enrollment
Peru
|
4 participants
n=37 Participants
|
8 participants
n=56 Participants
|
1 participants
n=95 Participants
|
13 participants
n=61 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=37 Participants
|
0 participants
n=56 Participants
|
0 participants
n=95 Participants
|
0 participants
n=61 Participants
|
PRIMARY outcome
Timeframe: Approximately 9 yearsPopulation: Fertility Sparing - hysterectomy not performed. Simple Hysterectomy - hysterectomy performed prior to study enrollment. Conization + hysterectomy + lymph node assessment group was only group assessed as Fertility Sparing did not have hysterectomy and the Simple Hysterectomy group had hysterectomy performed prior to study enrollment making them inevaluable.
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.
Outcome measures
| Measure |
Fertility Sparing
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
n=40 Participants
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
Inadvertent simple hysterectomy followed by lymph node dissection
|
|---|---|---|---|
|
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
|
—
|
2.5 percentage of participants
Interval 0.2 to 7.2
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Only 42 participants out of 44 in the fertility sparing group were evaluated; 1 participant expired following the surgical procedure and 1 participant was lost to follow up prior to the 2 year interval. In the conization + hysterectomy group, 4 participants of the 40 in this group were lost to follow up prior to the 2 year interval.
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.
Outcome measures
| Measure |
Fertility Sparing
n=42 Participants
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
n=36 Participants
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
n=16 Participants
Inadvertent simple hysterectomy followed by lymph node dissection
|
|---|---|---|---|
|
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
|
2.4 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Approximately 9 yearsTotal patient morbidity within 30 days following conservative surgery
Outcome measures
| Measure |
Fertility Sparing
n=44 Participants
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
n=40 Participants
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
n=16 Participants
Inadvertent simple hysterectomy followed by lymph node dissection
|
|---|---|---|---|
|
Number of Participants With All-Cause Mortality
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Fertility Sparing
Serious events: 5 serious events
Other events: 5 other events
Deaths: 1 deaths
Conization + Hysterectomy + Lymph Node Assessment
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Simple Hysterectomy
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fertility Sparing
n=44 participants at risk
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
n=40 participants at risk
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
n=16 participants at risk
Inadvertent simple hysterectomy followed by lymph node dissection
|
|---|---|---|---|
|
Reproductive system and breast disorders
Pelvic infection
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Reproductive system and breast disorders
Brusing/swelling in mons
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
6.2%
1/16 • Adverse events were reported for approximately 9 years
|
|
General disorders
Thrombolic event
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Renal and urinary disorders
Uterine obstruction
|
4.5%
2/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Nervous system disorders
Numbness right leg
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Skin and subcutaneous tissue disorders
Wound dehiscence
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
Other adverse events
| Measure |
Fertility Sparing
n=44 participants at risk
Conization followed by lymph node assessment only
|
Conization + Hysterectomy + Lymph Node Assessment
n=40 participants at risk
Conization followed by hysterectomy and lymph node assessment
|
Simple Hysterectomy
n=16 participants at risk
Inadvertent simple hysterectomy followed by lymph node dissection
|
|---|---|---|---|
|
Renal and urinary disorders
Bladder anastomotic leak
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
6.2%
1/16 • Adverse events were reported for approximately 9 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
General disorders
Hematoma
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
General disorders
Edema limbs
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
General disorders
Lymphedema
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
6.2%
1/16 • Adverse events were reported for approximately 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abnormal area of vagina noted
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
6.2%
1/16 • Adverse events were reported for approximately 9 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
6.2%
1/16 • Adverse events were reported for approximately 9 years
|
|
Vascular disorders
Vascular injury
|
2.3%
1/44 • Adverse events were reported for approximately 9 years
|
0.00%
0/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
General disorders
Left groin swelling
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
|
Skin and subcutaneous tissue disorders
Wound complication
|
0.00%
0/44 • Adverse events were reported for approximately 9 years
|
2.5%
1/40 • Adverse events were reported for approximately 9 years
|
0.00%
0/16 • Adverse events were reported for approximately 9 years
|
Additional Information
Kathleen Schmeler, MD
The University of Texas MD Anderson Cancer Center
Phone: (713) 854-9150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place