Trial Outcomes & Findings for Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor (NCT NCT01277744)

NCT ID: NCT01277744

Last Updated: 2020-01-13

Results Overview

Date of surgery to date of death or date of recurrence, whichever occurred first for patients who experienced an event, and to date of last follow-up for patients alive without recurrence

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 36 months after the last participant enrolled
• Results posted on: 2020-01-13

Participant Flow

Recruitment Details: May 2011 to December 2013

One patient was enrolled twice; she received a second hyperthermic intraperitoneal chemotherapy surgery after she recurred following the first procedure

Participant milestones

Measure	HIPEC HIPEC with Cisplatin
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	HIPEC HIPEC with Cisplatin
Overall Study Physician Decision	2

Baseline Characteristics

Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor

Baseline characteristics by cohort

Measure	HIPEC n=22 Participants HIPEC with Cisplatin
Age, Categorical <=18 years	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	15 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	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Region of Enrollment Russia	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months after the last participant enrolled

Date of surgery to date of death or date of recurrence, whichever occurred first for patients who experienced an event, and to date of last follow-up for patients alive without recurrence

Outcome measures

Measure	HIPEC n=20 Participants HIPEC with Cisplatin
Recurrence Free Survival	13.99 months Interval 7.26 to 95 percent are upper limit was not estimable

SECONDARY outcome

Timeframe: From the date of diagnosis to the date of death or last follow up date for patient alive up to 81 months

From the date of diagnosis to the date of death or last follow up date for patient alive.

Outcome measures

Measure	HIPEC n=20 Participants HIPEC with Cisplatin
Overall Survival	58.4 months Interval 43.7 to 95 percent are upper limit was not estimable

Adverse Events

HIPEC

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HIPEC n=20 participants at risk HIPEC with Cisplatin
Investigations Creatinine increased	10.0% 2/20 • 6 months post surgery
Investigations White blood cell decreased	70.0% 14/20 • 6 months post surgery
Investigations Platelet count decreased	75.0% 15/20 • 6 months post surgery
Gastrointestinal disorders Neurogenic bladder	15.0% 3/20 • 6 months post surgery
Infections and infestations Urinary tract infection	10.0% 2/20 • 6 months post surgery
Infections and infestations Wound infection	5.0% 1/20 • 6 months post surgery
Gastrointestinal disorders Enterocutaneous fistula	5.0% 1/20 • 6 months post surgery

Additional Information

Andrea Hayes-Jordan M.D. / Surgical Oncology

UT MD Anderson Cancer Center

Phone: 713-794-4616

Email: AHJORDAN@MDANDERSON.ORG

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place