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Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy

NCT02349958 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-04-16

No results posted yet for this study

Summary

To determine treatment response to surgical debulking and intra-operative Intraperitoneal Hyperthermic Chemotherapy (IPHC) in patients with the following malignancies:

Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical cancers).

Mesotheliomas. GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon, appendix).

To monitor the toxicities and complications of this treatment regimen. To measure treatment related QOL changes after IPHC.

Conditions

Interventions

DEVICE

HIPEC: MMC 30mg @ T0, 10mg @ T45min

MMC 30mg @ T0, 10mg @ T45min for Appendix, Psuedomyxoma, colorectal, small bowel

DEVICE

HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0

Gastric and Pancreato-biliary HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min

DEVICE

HIPEC: CDDP 75 mg/m2 @T0

Ovarian/peritoneal/fallopian tube, Uterine CDDP 75 mg/m2 @T0

DEVICE

HIPEC: CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0

CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0 Mesothelioma and Sarcoma

Sponsors & Collaborators

  • Bay Area Gynecology Oncology

    lead OTHER

Principal Investigators

  • James Lilja, MD · Bay Area Gynecology Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349958 on ClinicalTrials.gov