Flat Dose Vs. Weight-based IP Chemotherapy for CRS/HIPEC

Status Recruiting

Clinical Trial Summary

Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected peritoneal surfaces, has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited. Additionally, hyperthermia is known to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth of peritoneal penetration. This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity, compared with the HIPEC flat dosing approach in patients undergoing CRS/HIPEC.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04779554
Study type	Interventional
Source	University of Kentucky
Contact	Prakash Pandalai, MD
Phone	859-323-8920
Email	Prakash.Pandalai@uky.edu
Status	Recruiting
Phase	Phase 2
Start date	June 4, 2021
Completion date	February 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04826432` - Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis	Phase 2
Recruiting	`NCT03127774` - Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma	Phase 2
Recruiting	`NCT04024917` - Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis	N/A
Active, not recruiting	`NCT03508570` - Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis	Phase 1
Not yet recruiting	`NCT04352894` - Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection	N/A
Completed	`NCT06318793` - Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
Completed	`NCT05547568` - A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?
Terminated	`NCT01683864` - Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer	Phase 2/Phase 3
Recruiting	`NCT04547725` - Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis	N/A
Completed	`NCT03304210` - PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer	Phase 1
Withdrawn	`NCT03682744` - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)	Phase 1
Terminated	`NCT04047771` - A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis	Phase 1
Recruiting	`NCT05623787` - Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms	N/A
Recruiting	`NCT05063019` - Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index	N/A
Completed	`NCT02891447` - Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer	Phase 2
Recruiting	`NCT04231175` - Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer	N/A
Not yet recruiting	`NCT04734691` - Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study	Phase 2
Recruiting	`NCT04108936` - Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
Completed	`NCT02604784` - Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors	Phase 1/Phase 2
Terminated	`NCT01540344` - Combined Anticancer Treatment of Advanced Colon Cancer	Phase 2