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

NCT ID: NCT04779554

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-04

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Peritoneal Carcinomatosis

Keywords

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cytoreductive surgery colorectal cancer pseudomyxoma peritonei appendiceal mucinous neoplasm mitomycin C pharmacokinetics CRS/HIPEC HIPEC Appendix cancer LAMN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flat Dose Mitomycin C

Participants in this group will receive flat doses of mitomycin C intra-operatively: 1) 30mg at minute 0 and 2) 10mg at minute 45. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).

Group Type EXPERIMENTAL

Mitomycin C, flat dose 40 mg

Intervention Type DRUG

Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two flat doses. Dose 1 will be 30mg at minute 0 and dose 2 will be 10 mg at minute 45.

Weight-Based Mitomycin C

Participants in this group will receive weight-based dosing of mitomycin C intra-operatively: 1) 9.5 mg/m2 at minute 0 and 2) 3 mg/m2 at minute 45 for total dose of 12.5 mg/m2. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).

Group Type EXPERIMENTAL

Mitomycin C, weight-based dose 12.5 mg/m2

Intervention Type DRUG

Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two weight-based doses of 9.5 mg/m2 at minute 0 and 3 mg/m2 at minute 45.

Interventions

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Mitomycin C, flat dose 40 mg

Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two flat doses. Dose 1 will be 30mg at minute 0 and dose 2 will be 10 mg at minute 45.

Intervention Type DRUG

Mitomycin C, weight-based dose 12.5 mg/m2

Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two weight-based doses of 9.5 mg/m2 at minute 0 and 3 mg/m2 at minute 45.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis
* ECOG performance status \< 3
* Candidate for grossly complete cytoreductive surgery
* Life expectancy greater than 3 months
* Adequate organ and marrow function
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

* Any extra-abdominal metastases
* Untreated lung metastases
* Liver metastases not amenable to resection or ablation
* Known brain metastases
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Presence of residual significant adverse events attributed to prior cancer treatment
* Currently receiving any other investigational therapeutic agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.
* Pregnant or breast-feeding women
* Uncontrolled ongoing illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prakash Pandalai

OTHER

Sponsor Role lead

Responsible Party

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Prakash Pandalai

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Prakash Pandalai, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Prakash Pandalai, MD

Role: CONTACT

Phone: 859-323-8920

Email: [email protected]

Facility Contacts

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Prakash Pandalai, MD

Role: primary

Jessica Cintolo-Gonzalez

Role: primary

References

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McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

Reference Type DERIVED
PMID: 36410913 (View on PubMed)

Other Identifiers

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MCC-20-GI-115

Identifier Type: -

Identifier Source: org_study_id