Trial Outcomes & Findings for Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate (NCT NCT00165503)

Last Updated: 2016-09-09

Results Overview

Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.

Results posted on

2016-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Cisplatin, Sodium Thiosulfate, Alimta Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
Overall Study STARTED	16
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Cisplatin, Sodium Thiosulfate, Alimta Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
Overall Study Death	1
Overall Study Lost to Follow-up	12
Overall Study Unresectable	3

Baseline Characteristics

Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin, Sodium Thiosulfate, Alimta n=16 Participants Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
Age, Continuous	71.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	16 participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Region of Enrollment Israel	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.

Population: None of the enrolled participants were evaluated for the primary endpoint since none received the experimental adjuvant chemotherapy per protocol.

Outcome measures

Outcome data not reported

Adverse Events

Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate n=16 participants at risk Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.
Respiratory, thoracic and mediastinal disorders Pericardial effusion with tamponade	6.2% 1/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.
Respiratory, thoracic and mediastinal disorders Respiratory failure	18.8% 3/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.
Respiratory, thoracic and mediastinal disorders Progression of disease	6.2% 1/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.
Blood and lymphatic system disorders Hypocalcemia	6.2% 1/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.
Respiratory, thoracic and mediastinal disorders Chylothorax	6.2% 1/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	6.2% 1/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.
Respiratory, thoracic and mediastinal disorders Pneumonia	6.2% 1/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.
Blood and lymphatic system disorders Elevated troponin	6.2% 1/16 • The period for reporting adverse events were 30 days from the participant's date of surgery.

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Sugarbaker

Brigham and Women's Hospital

Phone: 617-732-5004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place