TriangleNCT02040142 · STUDY IN CONTEXT
HIPEC for Peritoneal Carcinomatosis
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Completeness of cytoreduction will be estimated and recorded using a complete cytoreduction (CC) which corresponds to a residual disease (RR) score. Completeness of Cytoreduction (CC) scores range from CC0 - CC3 and correlate to residual disease as follows: CC0 = R0: No Disease, complete removal of all visible tumor with negative cytology or microscopic margin CC1 = R1: \<= 0.25 cm; complete removal of all visible tumor with positive cytology or microscopic margin CC2 = R2a: 0.25-2.5 cm; minimal residual tumor, nodule(s) ≤ 0.5 cm CC3 =R2b: \>=2.5 cm; gross residual tumor, nodule(s), \> 0.5, but ≤ 2 cm CC3 =R2c: \>=2.5 cm; extensive disease remaining, nodule(s) \> 2 cm
Perioperative and Postoperative morbidity and mortality will be determined in patients with peritoneal carcinomatosis of colorectal, gastric, appendical, pseudomyxoma peritonei and peritoneal mesothelioma origin undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with Mitomycin- C. The number of peri/postoperative deaths up to 30 days following the time of surgery will be recorded.
PFS is defined as time from operation date to the first documentation of disease progression or death as a result of any cause, whichever comes first. PFS will be censored at the date of last documented progression-free status for patients who are still progression free, alive or lost to follow-up. Determination of disease progression will be based on: * Radiological (CT ± PET), and/or * Surgical (laparoscopic or open exploration) evidence of recurrent disease. Peritoneal disease progression will be confirmed by cytology or histology revealing cells morphologically consistent with malignant tumor cells
Overall survival will be calculated from the time of surgery to the time of death for any cause and will be censored at the date of last follow up visit for patients who are still alive or lost to follow up.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- trial label
- HIPEC for Peritoneal Carcinomatosis
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0000
- source section id
- NCT02040142-om-0000
- source outcome index
- 0
- endpoint
- Completeness of Cytoreduction
- endpoint definition
- Completeness of cytoreduction will be estimated and recorded using a complete cytoreduction (CC) which corresponds to a residual disease (RR) score. Completeness of Cytoreduction (CC) scores range from CC0 - CC3 and correlate to residual disease as follows: CC0 = R0: No Disease, complete removal of all visible tumor with negative cytology or microscopic margin CC1 = R1: \<= 0.25 cm; complete removal of all visible tumor with positive cytology or microscopic margin CC2 = R2a: 0.25-2.5 cm; minimal residual tumor, nodule(s) ≤ 0.5 cm CC3 =R2b: \>=2.5 cm; gross residual tumor, nodule(s), \> 0.5, but ≤ 2 cm CC3 =R2c: \>=2.5 cm; extensive disease remaining, nodule(s) \> 2 cm
- time origin
- Up through study discontinuation or 12 months after study treatment, whichever occurs first
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data was not collected and therefore Completeness of Cytoreduction was never able to be estimated.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0001
- source section id
- NCT02040142-om-0001
- source outcome index
- 1
- endpoint
- Perioperative and Postoperative Morbidity and Mortality
- endpoint definition
- Perioperative and Postoperative morbidity and mortality will be determined in patients with peritoneal carcinomatosis of colorectal, gastric, appendical, pseudomyxoma peritonei and peritoneal mesothelioma origin undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with Mitomycin- C. The number of peri/postoperative deaths up to 30 days following the time of surgery will be recorded.
- time origin
- Up to 30 days following surgery
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 30 day Morbidity data was not collected.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0002
- source section id
- NCT02040142-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- PFS is defined as time from operation date to the first documentation of disease progression or death as a result of any cause, whichever comes first. PFS will be censored at the date of last documented progression-free status for patients who are still progression free, alive or lost to follow-up. Determination of disease progression will be based on: * Radiological (CT ± PET), and/or * Surgical (laparoscopic or open exploration) evidence of recurrent disease. Peritoneal disease progression will be confirmed by cytology or histology revealing cells morphologically consistent with malignant tumor cells
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- For PFS, 14/51 patients were not evaluable due to either never having completed surgery, not receiving HIPEC, having no evidence of cancer at time of surgery, or death due to HIPEC and no response measurement. As such, 37 patients were evaluable for PFS.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0003
- source section id
- NCT02040142-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival will be calculated from the time of surgery to the time of death for any cause and will be censored at the date of last follow up visit for patients who are still alive or lost to follow up.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- For OS, 12/51 patients were not evaluable due to either never having completed surgery, not receiving HIPEC, or having no evidence of cancer at time of surgery. As such, 39 patients were evaluable for OS. 2 patients died within 30 days of surgery and, as such, the full range of dates was 0 months to time of last follow up prior to study termination (i.e., 60 months)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0000
- arm key
- OG000
- arm label
- HIPEC + Mitomycin C
- regimen
- HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02040142-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0001
- arm key
- OG000
- arm label
- HIPEC + Mitomycin C
- regimen
- HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
- analyzed count
- 51
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02040142-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0002
- arm key
- OG000
- arm label
- HIPEC + Mitomycin C
- regimen
- HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02040142-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- outcome key
- om-0003
- arm key
- OG000
- arm label
- HIPEC + Mitomycin C
- regimen
- HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02040142-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT02040142
- harm key
- EG000
- source section id
- NCT02040142-ae
- event group key
- EG000
- event group label
- HIPEC + Mitomycin C
- serious affected
- 34
- serious at risk
- 51
- other affected
- 50
- other at risk
- 51
- frequency threshold
- 0
- collection period
- Assessed throughout enrollment following the initiation of study treatment, up to 5 years
- event definition
- Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice