Trial Outcomes & Findings for S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer (NCT NCT00008138)
NCT ID: NCT00008138
Last Updated: 2016-01-08
Results Overview
Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
Results posted on
2016-01-08
Participant Flow
Of 62 enrolled participants, 4 were deemed ineligible.
Participant milestones
| Measure |
Experimental: Chemo/Debulking Surgery/IP Chemo
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
|
|---|---|
|
Neoadjuvant Chemotherapy
STARTED
|
58
|
|
Neoadjuvant Chemotherapy
Eligible
|
58
|
|
Neoadjuvant Chemotherapy
COMPLETED
|
38
|
|
Neoadjuvant Chemotherapy
NOT COMPLETED
|
20
|
|
Interval Debulking
STARTED
|
38
|
|
Interval Debulking
Received Protocol Surgery
|
36
|
|
Interval Debulking
COMPLETED
|
36
|
|
Interval Debulking
NOT COMPLETED
|
2
|
|
Post-Cytoreduction Chemotherapy
STARTED
|
26
|
|
Post-Cytoreduction Chemotherapy
COMPLETED
|
18
|
|
Post-Cytoreduction Chemotherapy
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Experimental: Chemo/Debulking Surgery/IP Chemo
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
|
|---|---|
|
Neoadjuvant Chemotherapy
Adverse Event
|
3
|
|
Neoadjuvant Chemotherapy
Withdrawal by Subject
|
3
|
|
Neoadjuvant Chemotherapy
Lack of Efficacy
|
6
|
|
Neoadjuvant Chemotherapy
not protocol specified
|
8
|
|
Interval Debulking
Withdrawal by Subject
|
2
|
|
Post-Cytoreduction Chemotherapy
Adverse Event
|
6
|
|
Post-Cytoreduction Chemotherapy
Progression
|
1
|
|
Post-Cytoreduction Chemotherapy
not protocol specified
|
1
|
Baseline Characteristics
S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Experimental: Chemo/Debulking Surgery/IP Chemo
n=58 Participants
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Stage
Stage III
|
43 participants
n=5 Participants
|
|
Stage
Stage IV
|
15 participants
n=5 Participants
|
|
Primary Site
Ovary
|
43 participants
n=5 Participants
|
|
Primary Site
Peritoneal
|
14 participants
n=5 Participants
|
|
Primary Site
Not reported
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5Population: Only eligible patients were included in the analysis.
Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.
Outcome measures
| Measure |
Experimental: Chemo/Debulking Surgery/IP Chemo
n=58 Participants
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
|
|---|---|
|
Overall Survival
|
32 months
Interval 22.0 to 37.0
|
PRIMARY outcome
Timeframe: Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.Population: Only eligible patients were included in the analysis.
Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.
Outcome measures
| Measure |
Experimental: Chemo/Debulking Surgery/IP Chemo
n=58 Participants
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
|
|---|---|
|
Progression-Free Survival
|
21 months
Interval 15.0 to 32.0
|
Adverse Events
Neoadjuvant Paclitaxel (IV) + Carboplatin (V)
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Paclitaxel (IV) + Carboplatin (V)
n=58 participants at risk
Pre-surgery IV chemotherapy with paclitaxel and carboplatin
|
Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)
n=26 participants at risk
post-surgery chemotherapy with IV and IP carboplatin and paclitaxel
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/58 • Number of events 1 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
Other adverse events
| Measure |
Neoadjuvant Paclitaxel (IV) + Carboplatin (V)
n=58 participants at risk
Pre-surgery IV chemotherapy with paclitaxel and carboplatin
|
Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)
n=26 participants at risk
post-surgery chemotherapy with IV and IP carboplatin and paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
24.1%
14/58 • Number of events 14 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
53.8%
14/26 • Number of events 14 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Blood and lymphatic system disorders
PRBC transfusion
|
27.6%
16/58 • Number of events 16 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Blood and lymphatic system disorders
Platelet transfusion
|
6.9%
4/58 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
17.2%
10/58 • Number of events 10 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
53.8%
14/26 • Number of events 14 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
34.6%
9/26 • Number of events 9 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
26.9%
7/26 • Number of events 7 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Gastrointestinal disorders
Ileus
|
6.9%
4/58 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Gastrointestinal disorders
Nausea
|
8.6%
5/58 • Number of events 5 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
46.2%
12/26 • Number of events 12 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
4/58 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
34.6%
9/26 • Number of events 9 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
General disorders
Edema
|
8.6%
5/58 • Number of events 5 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
General disorders
Fatigue/malaise/lethargy
|
29.3%
17/58 • Number of events 17 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
57.7%
15/26 • Number of events 15 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
General disorders
Fever without neutropenia
|
8.6%
5/58 • Number of events 5 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
General disorders
Pain-other
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Immune system disorders
Allergic reaction
|
6.9%
4/58 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
6.9%
4/58 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Infections and infestations
Respiratory infect w/o neutrop
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Infections and infestations
Urinary tr infect w/ neutrop
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Infections and infestations
Urinary tr infect w/o neutrop
|
8.6%
5/58 • Number of events 5 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Injury, poisoning and procedural complications
Catheter related infection
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Injury, poisoning and procedural complications
Local injection site reaction
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Injury, poisoning and procedural complications
Surgery-hemorrhage
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Investigations
Leukopenia
|
15.5%
9/58 • Number of events 9 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
65.4%
17/26 • Number of events 17 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Investigations
Neutropenia/granulocytopenia
|
22.4%
13/58 • Number of events 13 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
57.7%
15/26 • Number of events 15 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Investigations
SGOT (AST) increase
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Investigations
Thrombocytopenia
|
12.1%
7/58 • Number of events 7 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
42.3%
11/26 • Number of events 11 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Investigations
Weight loss
|
8.6%
5/58 • Number of events 5 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
11/58 • Number of events 11 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
15.4%
4/26 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
0.00%
0/26 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.6%
5/58 • Number of events 5 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
15.4%
4/26 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
23.1%
6/26 • Number of events 6 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not neuro)
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
15.4%
4/26 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Nervous system disorders
Dizziness/light headedness
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Nervous system disorders
Headache
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Nervous system disorders
Sensory neuropathy
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
42.3%
11/26 • Number of events 11 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Nervous system disorders
Weakness (motor neuropathy)
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Psychiatric disorders
Anxiety/agitation
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
11.5%
3/26 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.3%
6/58 • Number of events 6 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
15.4%
4/26 • Number of events 4 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
38.5%
10/26 • Number of events 10 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Vascular disorders
Hot flashes
|
0.00%
0/58 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
|
Vascular disorders
Thrombosis/embolism
|
5.2%
3/58 • Number of events 3 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
7.7%
2/26 • Number of events 2 • Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
|
Additional Information
GYN Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place