Trial Outcomes & Findings for Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma (NCT NCT01519869)
NCT ID: NCT01519869
Last Updated: 2020-12-14
Results Overview
Percentage of patients that achieve maximal surgical debulking as defined by no gross residual disease following a Simon's 2-stage design.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
5 years
Results posted on
2020-12-14
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Chemotherapy
platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Neoadjuvant Chemotherapy
platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma
Baseline characteristics by cohort
| Measure |
Neoadjuvant Chemotherapy
n=28 Participants
platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
|
|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Only twenty-five patients were evaluated for gross residual disease.
Percentage of patients that achieve maximal surgical debulking as defined by no gross residual disease following a Simon's 2-stage design.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=25 Participants
platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
|
|---|---|
|
Percentage of Patients That Achieve Maximal Surgical Debulking
|
10 Participants
|
Adverse Events
Neoadjuvant Chemotherapy
Serious events: 0 serious events
Other events: 28 other events
Deaths: 23 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neoadjuvant Chemotherapy
n=28 participants at risk
platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
5/28 • Number of events 6 • 5 years
|
|
Immune system disorders
Allergic reaction
|
3.6%
1/28 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
6/28 • Number of events 8 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
10.7%
3/28 • Number of events 5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Infections and infestations
Catheter related infection
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colonic perforation
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Confusion
|
7.1%
2/28 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
32.1%
9/28 • Number of events 14 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
21.4%
6/28 • Number of events 10 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
5/28 • Number of events 12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.9%
5/28 • Number of events 6 • 5 years
|
|
General disorders
Fatigue
|
53.6%
15/28 • Number of events 21 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.7%
3/28 • Number of events 3 • 5 years
|
|
General disorders
Fever
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Vascular disorders
Hematoma
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Vascular disorders
Hot flashes
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 5 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Insomnia
|
21.4%
6/28 • Number of events 6 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
2/28 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
35.7%
10/28 • Number of events 21 • 5 years
|
|
Investigations
Neutrophil count decreased
|
39.3%
11/28 • Number of events 24 • 5 years
|
|
General disorders
Pain
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.9%
12/28 • Number of events 20 • 5 years
|
|
Investigations
Platelet count decreased
|
14.3%
4/28 • Number of events 10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Number of events 2 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
7/28 • Number of events 14 • 5 years
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Infections and infestations
Wound infection
|
7.1%
2/28 • Number of events 2 • 5 years
|
|
Investigations
White blood cell decreased
|
14.3%
4/28 • Number of events 8 • 5 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Infections and infestations
Bronchial infection
|
3.6%
1/28 • Number of events 1 • 5 years
|
|
Infections and infestations
Device related infection
|
3.6%
1/28 • Number of events 1 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place