Trial Outcomes & Findings for Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia (NCT NCT02739698)

Results Overview

Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.

Results posted on

2017-08-01

Participant Flow

43 subjects were recruited but 11 were excluded after the pathologist samples review

Participant milestones

Participant milestones
Measure	Normothermic (36-37ºC) Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC). Paclitaxel Radical surgery-peritonectomy (ovarian carcinomatosis)	Hyperthermic (41-42ºC) Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC). Paclitaxel Radical surgery-peritonectomy (ovarian carcinomatosis)
Overall Study STARTED	22	21
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normothermic (36-37ºC) n=16 Participants Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC). Paclitaxel Radical surgery-peritonectomy (ovarian carcinomatosis)	Hyperthermic (41-42ºC) n=16 Participants Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC). Paclitaxel Radical surgery-peritonectomy (ovarian carcinomatosis)	Total n=32 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	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.

Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).

Outcome measures

Outcome measures
Measure	Normothermic (36-37ºC) n=16 Participants Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC). Paclitaxel Radical surgery-peritonectomy	Hyperthermic (41-42ºC) n=16 Participants Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (41-42ºC). Paclitaxel Radical surgery-peritonectomy
The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)	18.8 percentage of complete pathological resp	25 percentage of complete pathological resp

Adverse Events

Normothermic (36-37ºC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hyperthermic (41-42ºC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Casado-Adam, MD

University Hospital Reina Sofia, Cordoba, Spain

Phone: 0034957010439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place