Trial Outcomes & Findings for Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix (NCT NCT01365156)
NCT ID: NCT01365156
Last Updated: 2021-02-03
Results Overview
To determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging followed by tailored chemoradiation when compared to patients who undergo standard radiologic staging followed by whole pelvic chemoradiation therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
3 years
Results posted on
2021-02-03
Participant Flow
The study was activated on 08/03/2011 and closed to new patient entry on 03/18/2016. All recruitments were done in a medical clinic setting.
Participant milestones
| Measure |
Surgery Group
Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation
|
Chemoradiation Group
Standard of care whole pelvic chemoradiation therapy
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix
Baseline characteristics by cohort
| Measure |
Surgery Group
n=14 Participants
Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation
|
Chemoradiation Group
n=14 Participants
Standard of care whole pelvic chemoradiation therapy
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
47 years
n=93 Participants
|
46 years
n=4 Participants
|
46 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
20 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Due to lack of funding and low accrual we were unable to determine the Overall Survival Rate.
To determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging followed by tailored chemoradiation when compared to patients who undergo standard radiologic staging followed by whole pelvic chemoradiation therapy.
Outcome measures
Outcome data not reported
Adverse Events
Surgery Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Chemoradiation Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Surgery Group
n=14 participants at risk
Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation
|
Chemoradiation Group
n=14 participants at risk
Standard of care whole pelvic chemoradiation therapy
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
14.3%
2/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
0.00%
0/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
14.3%
2/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
0.00%
0/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
General disorders
Fatigue
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
0.00%
0/14 • AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
|
Additional Information
Michael Frumovitz,Professor, Gyn Onc & Reproductive Med
UT MD Anderson Cancer Center
Phone: (713) 792-9599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place