NCT04779554RecruitingPhase 2
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 27 Feb 2021
- Start date
- 4 Jun 2021
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Prakash Pandalai
- Diseases
- Colorectal cancer
- NCT number
- NCT04779554
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 4 Jun 2021 to the primary completion date, 29 Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Liver metastases not amenable to resection or ablation
- Chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Currently receiving any other investigational therapeutic agents
Other illness
- Presence of residual significant adverse events attributed to prior cancer treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.
- Uncontrolled ongoing illness
Other
- Any extra-abdominal metastases
- Untreated lung metastases
- Known brain metastases
- Pregnant or breast-feeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.