Pseudomyxoma PeritoneiPhase 2HIPEC-IAPNCT02949791
HIPEC Using High Intra-abdominal Pressure
A Phase 2 study testing Cytoreductive surgery, Low Intra abdominal pressure HIPEC and High Intra abdominal pressure HIPEC in people with Pseudomyxoma Peritonei and Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a promising therapy for peritoneal carcinomatosis (PC) of various origins. Rather than the pharmacokinetic advantage, the uptake of chemotherapy by tumor tissue has been proposed as the best pharmacologic endpoint to assure the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pseudomyxoma Peritonei, Colorectal Cancer
- What is being tested?
- Cytoreductive surgery, Low Intra abdominal pressure HIPEC and High Intra abdominal pressure HIPEC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of primary peritoneal carcinomatosis from colorectal origin or pseudomyxoma peritonei
- Patients submitted to complete cytoreduction with residual tumor <2.5 mm
- Patients at the end of cytoreduction should present the laboratorial and hemodynamic parameters set as followings:
- Mean arterial pressure > 65 mmHg
- Heart rate: < 100 bpm
- Central venous pressure > 4 mmHg
Show all 10Show fewer
- Cardiac index > 2.2
- Central venous oxygen saturation (ScvO2) > 72%, and
- Haemoglobin > 8.0 gr/dl.
- Informed consent signed from the patient before the procedure.
Who cannot join
- Severe hemodynamic and/or respiratory instability after the cytoreduction that precludes HIPEC.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, MI, 20133
About this study
Official title: Effects of High Intra-abdominal Pressure on Tissue Diffusion and Pharmacokinetics of Cisplatin During HIPEC
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a promising therapy for peritoneal carcinomatosis (PC) of various origins. Rather than the pharmacokinetic advantage, the uptake of chemotherapy by tumor tissue has been proposed as the best pharmacologic endpoint to assure the efficacy of HIPEC.
The primary endpoints of the present phase II randomized study are to test whether the increased intra abdominal pressure (IAP) during HIPEC could:
Read more
- enhance the penetration of cisplatin into the residual neoplastic and normal tissues;
- elicit changes on pharmacokinetic advantage of cisplatin.
Secondary endpoints are to evaluate the:
- impact of high IAP on intraoperatory hemodynamic and respiratory parameters;
- impact on short-term surgical outcomes (in hospital stay, morbidity, mortality).
Patients affected by PC from colorectal cancer or pseudomyxoma peritonei, submitted to complete cytoreduction (residual disease <2.5mm) would be eligible for the study. HIPEC will be performed using closed abdomen technique and cisplatin + mitomycin-C. Patients will be randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be measured using bladder catheter. High IAP will be obtained increasing the volume of perfusate.
Thirty-eight patients (19 in each study groups) will be enrolled in 30 months. The randomized groups will be stratified according to tumor type.
Read the detailed description
Patients affected by peritoneal metastasis from colorectal cancer or pseudomyxoma peritonei, submitted to complete cytoreduction (residual disease <2.5mm) would be eligible for the study. Residual and resectable tumour nodules of 0.5 to 1.0 cm will be left behind after the cytoreduction and they will be collected at the end of HIPEC for the purpose of this study. HIPEC will be performed using closed abdomen technique and cisplatin (42mg/L of perfusate) + mitomycin-C (3.3mg/m2/L of perfusate) for 60 minutes, at 42.5°C. Patients will be randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be measured using bladder catheter. Patients of high IAP group will be strictly monitored during the perfusion regarding hemodynamic/respiratory parameters. During the HIPEC, perfusate and blood samples will be collected every 10 minutes. Additional samples of arterial blood will be collected at 70, 90,120,180 and 240 minutes. After the completion of HIPEC residual tumor tissues, normal peritoneum and muscular fascia will be sampled for determination of cisplatin concentration.
Blood samples will be immediately centrifuged to separate plasma. An aliquot of plasma will be stored at -30°C for total platinum determination. Another aliquot will be ultrafiltered by centrifugation through a membrane with a cut-off 5000 Da for ultrafilterable platinum determination. The ultrafiltrate will be stored at -30°C until analysis.
Perfusate samples will follow the same procedure of blood samples. Tissues samples will be stored at -80°C until analysis. Platinum determination will be performed using an Inductive Coupled Plasma Mass Spectrometry (ICP-MS) system by Thermo Scientific after preparing calibration curves with atomic platinum. Fluid samples simply dilute before ICP-MS examination while tissues will be desiccated, digested with a mixture of nitric acid and oxygen water, and evaporated to dryness prior to determination.
The investigators will compare the following outcomes between the study groups: tumor tissue concentration of cisplatin; the area under the curve (AUC) ratio of perfusate UF concentration of cisplatin times time to plasma UF concentration times time; in-hospital stay; systemic toxicity (NCI-CTCAE.v3), morbidity, and mortality.
Thirty eight patients (19 in each group) would be needed to detect an increase cisplatin concentration of 20 ng/mg of tumor tissue if patients are submitted to high-IAP during HIPEC, assuming alfa=0.05 and power=0.90 and standard deviation of 15 ng. Accrual time will be 30 months. The randomized groups will be stratified according to tumor type.
- Conditions
- Pseudomyxoma Peritonei, Colorectal Cancer
- Being tested
- Cytoreductive surgery, Low Intra abdominal pressure HIPEC, High Intra abdominal pressure HIPEC
- Keywords
- cisplatin, HIPEC, Intra abdominal pressure, tissue drug concentration
- Medical subject headings
- Pseudomyxoma Peritonei, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgeryProcedure or surgery
Also called Peritonectomy procedures
Maximal surgical effort to obtain a minimal residual disease of less than 2.5 mm
Low Intra abdominal pressure HIPECOther
Hyperthermic intraperitoneal chemotherapy using closed modality and intra abdominal pressure of 8-12 mmHg
High Intra abdominal pressure HIPECOther
Hyperthermic intraperitoneal chemotherapy using closed modality and intra abdominal pressure of 18-22 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Low Intra abdominal pressure HIPEC | Active comparator | Cytoreductive surgery and HIPEC with low intra-abdominal pressure Receives: Procedure: Cytoreductive surgery; Other: Low Intra abdominal pressure HIPEC |
| High Intra abdominal pressure HIPEC | Experimental | Cytoreductive surgery and HIPEC with high intra-abdominal pressure Receives: Procedure: Cytoreductive surgery; Other: High Intra abdominal pressure HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor tissue concentration of cisplatin
residual neoplastic tissue concentration of cisplatin measured in ng/mg
Measured: collected within 15 minutes after the completion of HIPEC
Normal tissue concentration of cisplatin
tissue concentration of cisplatin measured in ng/mg in peritoneum of mesentery and rectal muscle fascia
Measured: collected within 15 minutes after the completion of HIPEC
Secondary outcomes (11)
Pharmacokinetic advantage
Peritoneal to plasma area under the curve (AUC) ratio of ultrafiltrated cisplatin concentrations
Measured: During the HIPEC up to 1 hour from the completion of perfusion
Pharmacokinetic advantage 2
Peritoneal to plasma area under the curve (AUC) ratio of total protein bound cisplatin concentrations
Measured: During the HIPEC up to 1 hour from the completion of perfusion
Impact of high intra-abdominal pressure on anesthesiologic parameters 1
Mean arterial pressure (mmHg)
Measured: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 2
Heart rate (beats per minute)
Measured: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 3
Central venous pressure (mmHg)
Measured: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 4
Cardiac index
Measured: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 5
Arterial oxygen saturation (PaO2)
Measured: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 6
Central venous oxygen saturation (ScvO2)
Measured: Intraoperative phase
Impact of intraoperative high intra-abdominal pressure on short-term surgical outcomes 1
Surgical complications (NCI CTCAEv3)
Measured: within 30 days after surgery
Impact of intraoperative high intra-abdominal pressure on short-term surgical outcomes 2
Systemic toxicity (NCI CTCAEv3)
Measured: within 30 days after surgery
Impact of intraoperative high intra-abdominal pressure on short-term surgical outcomes 3
Mortality
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startDec 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Responsible party
- Principal investigator, Shigeki Kusamura, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Shigeki Kusamura, MD PhD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949791
- Sponsor's protocol ID
- AIRC-2013-144445
- Acronym
- HIPEC-IAP
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2016
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Esquis P, Consolo D, Magnin G, Pointaire P, Moretto P, Ynsa MD, Beltramo JL, Drogoul C, Simonet M, Benoit L, Rat P, Chauffert B. High intra-abdominal pressure enhances the penetration and antitumor effect of intraperitoneal cisplatin on experimental peritoneal carcinomatosis. Ann Surg. 2006 Jul;244(1):106-12. doi: 10.1097/01.sla.0000218089.61635.5f.
PubMed 16794395Facy O, Al Samman S, Magnin G, Ghiringhelli F, Ladoire S, Chauffert B, Rat P, Ortega-Deballon P. High pressure enhances the effect of hyperthermia in intraperitoneal chemotherapy with oxaliplatin: an experimental study. Ann Surg. 2012 Dec;256(6):1084-8. doi: 10.1097/SLA.0b013e3182582b38.
PubMed 22634898Facy O, Combier C, Poussier M, Magnin G, Ladoire S, Ghiringhelli F, Chauffert B, Rat P, Ortega-Deballon P. High pressure does not counterbalance the advantages of open techniques over closed techniques during heated intraperitoneal chemotherapy with oxaliplatin. Surgery. 2015 Jan;157(1):72-8. doi: 10.1016/j.surg.2014.06.006. Epub 2014 Jul 12.
PubMed 25027716Rossi CR, Foletto M, Mocellin S, Pilati P, De SM, Deraco M, Cavaliere F, Palatini P, Guasti F, Scalerta R, Lise M. Hyperthermic intraoperative intraperitoneal chemotherapy with cisplatin and doxorubicin in patients who undergo cytoreductive surgery for peritoneal carcinomatosis and sarcomatosis: phase I study. Cancer. 2002 Jan 15;94(2):492-9. doi: 10.1002/cncr.10176.
PubMed 11900234Jacquet P, Stuart OA, Chang D, Sugarbaker PH. Effects of intra-abdominal pressure on pharmacokinetics and tissue distribution of doxorubicin after intraperitoneal administration. Anticancer Drugs. 1996 Jul;7(5):596-603. doi: 10.1097/00001813-199607000-00016.
PubMed 8862729Van der Speeten K, Stuart OA, Sugarbaker PH. Pharmacokinetics and pharmacodynamics of perioperative cancer chemotherapy in peritoneal surface malignancy. Cancer J. 2009 May-Jun;15(3):216-24. doi: 10.1097/PPO.0b013e3181a58d95.
PubMed 19556908Kusamura S, Azmi N, Fumagalli L, Baratti D, Guaglio M, Cavalleri A, Garrone G, Battaglia L, Barretta F, Deraco M. Phase II randomized study on tissue distribution and pharmacokinetics of cisplatin according to different levels of intra-abdominal pressure (IAP) during HIPEC (NCT02949791). Eur J Surg Oncol. 2021 Jan;47(1):82-88. doi: 10.1016/j.ejso.2019.06.022. Epub 2019 Jun 21.
PubMed 31262599
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intra-abdominal Pressure on Tissue Diffusion and Pharmacokinetics of Cisplatin During HIPEC
- ClinicalTrials.gov ID
- NCT02949791
- Acronym / sponsor ID
- HIPEC-IAP / AIRC-2013-144445
- Conditions
- Pseudomyxoma Peritonei, Colorectal Cancer
- Keywords
- cisplatin, HIPEC, Intra abdominal pressure, tissue drug concentration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a promising therapy for peritoneal carcinomatosis (PC) of various origins. Rather than the pharmacokinetic advantage, the uptake of chemotherapy by tumor tissue has been proposed as the best pharmacologic endpoint to assure the efficacy of HIPEC.
The primary endpoints of the present phase II randomized study are to test whether the increased intra abdominal pressure (IAP) during HIPEC could:
- enhance the penetration of cisplatin into the residual neoplastic and normal tissues;
- elicit changes on pharmacokinetic advantage of cisplatin.
Secondary endpoints are to evaluate the:
- impact of high IAP on intraoperatory hemodynamic and respiratory parameters;
- impact on short-term surgical outcomes (in hospital stay, morbidity, mortality).
Patients affected by PC from colorectal cancer or pseudomyxoma peritonei, submitted to complete cytoreduction (residual disease <2.5mm) would be eligible for the study. HIPEC will be performed using closed abdomen technique and cisplatin + mitomycin-C. Patients will be randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be measured using bladder catheter. High IAP will be obtained increasing the volume of perfusate.
Thirty-eight patients (19 in each study groups) will be enrolled in 30 months. The randomized groups will be stratified according to tumor type.
Detailed description
Patients affected by peritoneal metastasis from colorectal cancer or pseudomyxoma peritonei, submitted to complete cytoreduction (residual disease <2.5mm) would be eligible for the study. Residual and resectable tumour nodules of 0.5 to 1.0 cm will be left behind after the cytoreduction and they will be collected at the end of HIPEC for the purpose of this study. HIPEC will be performed using closed abdomen technique and cisplatin (42mg/L of perfusate) + mitomycin-C (3.3mg/m2/L of perfusate) for 60 minutes, at 42.5°C. Patients will be randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be measured using bladder catheter. Patients of high IAP group will be strictly monitored during the perfusion regarding hemodynamic/respiratory parameters. During the HIPEC, perfusate and blood samples will be collected every 10 minutes. Additional samples of arterial blood will be collected at 70, 90,120,180 and 240 minutes. After the completion of HIPEC residual tumor tissues, normal peritoneum and muscular fascia will be sampled for determination of cisplatin concentration.
Blood samples will be immediately centrifuged to separate plasma. An aliquot of plasma will be stored at -30°C for total platinum determination. Another aliquot will be ultrafiltered by centrifugation through a membrane with a cut-off 5000 Da for ultrafilterable platinum determination. The ultrafiltrate will be stored at -30°C until analysis.
Perfusate samples will follow the same procedure of blood samples. Tissues samples will be stored at -80°C until analysis. Platinum determination will be performed using an Inductive Coupled Plasma Mass Spectrometry (ICP-MS) system by Thermo Scientific after preparing calibration curves with atomic platinum. Fluid samples simply dilute before ICP-MS examination while tissues will be desiccated, digested with a mixture of nitric acid and oxygen water, and evaporated to dryness prior to determination.
The investigators will compare the following outcomes between the study groups: tumor tissue concentration of cisplatin; the area under the curve (AUC) ratio of perfusate UF concentration of cisplatin times time to plasma UF concentration times time; in-hospital stay; systemic toxicity (NCI-CTCAE.v3), morbidity, and mortality.
Thirty eight patients (19 in each group) would be needed to detect an increase cisplatin concentration of 20 ng/mg of tumor tissue if patients are submitted to high-IAP during HIPEC, assuming alfa=0.05 and power=0.90 and standard deviation of 15 ng. Accrual time will be 30 months. The randomized groups will be stratified according to tumor type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intra abdominal pressure HIPEC | Active comparator | Procedure: Cytoreductive surgery, Other: Low Intra abdominal pressure HIPECCytoreductive surgery and HIPEC with low intra-abdominal pressure |
| High Intra abdominal pressure HIPEC | Experimental | Procedure: Cytoreductive surgery, Other: High Intra abdominal pressure HIPECCytoreductive surgery and HIPEC with high intra-abdominal pressure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological diagnosis of primary peritoneal carcinomatosis from colorectal origin or pseudomyxoma peritonei
- Patients submitted to complete cytoreduction with residual tumor <2.5 mm
- Patients at the end of cytoreduction should present the laboratorial and hemodynamic parameters set as followings:
- Informed consent signed from the patient before the procedure.
Key exclusion criteria (1 listed)
- Severe hemodynamic and/or respiratory instability after the cytoreduction that precludes HIPEC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytoreductive surgeryAlso: Peritonectomy proceduresMaximal surgical effort to obtain a minimal residual disease of less than 2.5 mm | Procedure or surgery | High Intra abdominal pressure HIPEC, Low Intra abdominal pressure HIPEC |
| Low Intra abdominal pressure HIPECHyperthermic intraperitoneal chemotherapy using closed modality and intra abdominal pressure of 8-12 mmHg | Other | Low Intra abdominal pressure HIPEC |
| High Intra abdominal pressure HIPECHyperthermic intraperitoneal chemotherapy using closed modality and intra abdominal pressure of 18-22 mmHg | Other | High Intra abdominal pressure HIPEC |
Primary outcome
Tumor tissue concentration of cisplatin
Time frame: collected within 15 minutes after the completion of HIPEC
residual neoplastic tissue concentration of cisplatin measured in ng/mg
Normal tissue concentration of cisplatin
Time frame: collected within 15 minutes after the completion of HIPEC
tissue concentration of cisplatin measured in ng/mg in peritoneum of mesentery and rectal muscle fascia
11 secondary outcomes
Pharmacokinetic advantage
Time frame: During the HIPEC up to 1 hour from the completion of perfusion
Pharmacokinetic advantage 2
Time frame: During the HIPEC up to 1 hour from the completion of perfusion
Impact of high intra-abdominal pressure on anesthesiologic parameters 1
Time frame: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 2
Time frame: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 3
Time frame: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 4
Time frame: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 5
Time frame: Intraoperative phase
Impact of high intra-abdominal pressure on anesthesiologic parameters 6
Time frame: Intraoperative phase
Impact of intraoperative high intra-abdominal pressure on short-term surgical outcomes 1
Time frame: within 30 days after surgery
Impact of intraoperative high intra-abdominal pressure on short-term surgical outcomes 2
Time frame: within 30 days after surgery
Impact of intraoperative high intra-abdominal pressure on short-term surgical outcomes 3
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Background: PubMed 16794395Esquis P, Consolo D, Magnin G, Pointaire P, Moretto P, Ynsa MD, Beltramo JL, Drogoul C, Simonet M, Benoit L, Rat P, Chauffert B. High intra-abdominal pressure enhances the penetration and antitumor effect of intraperitoneal cisplatin on experimental peritoneal carcinomatosis. Ann Surg. 2006 Jul;244(1):106-12. doi: 10.1097/01.sla.0000218089.61635.5f.
- Background: PubMed 22634898Facy O, Al Samman S, Magnin G, Ghiringhelli F, Ladoire S, Chauffert B, Rat P, Ortega-Deballon P. High pressure enhances the effect of hyperthermia in intraperitoneal chemotherapy with oxaliplatin: an experimental study. Ann Surg. 2012 Dec;256(6):1084-8. doi: 10.1097/SLA.0b013e3182582b38.
- Background: PubMed 25027716Facy O, Combier C, Poussier M, Magnin G, Ladoire S, Ghiringhelli F, Chauffert B, Rat P, Ortega-Deballon P. High pressure does not counterbalance the advantages of open techniques over closed techniques during heated intraperitoneal chemotherapy with oxaliplatin. Surgery. 2015 Jan;157(1):72-8. doi: 10.1016/j.surg.2014.06.006. Epub 2014 Jul 12.
- Background: PubMed 11900234Rossi CR, Foletto M, Mocellin S, Pilati P, De SM, Deraco M, Cavaliere F, Palatini P, Guasti F, Scalerta R, Lise M. Hyperthermic intraoperative intraperitoneal chemotherapy with cisplatin and doxorubicin in patients who undergo cytoreductive surgery for peritoneal carcinomatosis and sarcomatosis: phase I study. Cancer. 2002 Jan 15;94(2):492-9. doi: 10.1002/cncr.10176.
- Background: PubMed 8862729Jacquet P, Stuart OA, Chang D, Sugarbaker PH. Effects of intra-abdominal pressure on pharmacokinetics and tissue distribution of doxorubicin after intraperitoneal administration. Anticancer Drugs. 1996 Jul;7(5):596-603. doi: 10.1097/00001813-199607000-00016.
- Background: PubMed 19556908Van der Speeten K, Stuart OA, Sugarbaker PH. Pharmacokinetics and pharmacodynamics of perioperative cancer chemotherapy in peritoneal surface malignancy. Cancer J. 2009 May-Jun;15(3):216-24. doi: 10.1097/PPO.0b013e3181a58d95.
- Derived from this study: PubMed 31262599Kusamura S, Azmi N, Fumagalli L, Baratti D, Guaglio M, Cavalleri A, Garrone G, Battaglia L, Barretta F, Deraco M. Phase II randomized study on tissue distribution and pharmacokinetics of cisplatin according to different levels of intra-abdominal pressure (IAP) during HIPEC (NCT02949791). Eur J Surg Oncol. 2021 Jan;47(1):82-88. doi: 10.1016/j.ejso.2019.06.022. Epub 2019 Jun 21.
- Individual participant dataSharing planned: No
Related trials for Pseudomyxoma Peritonei
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
Not yet recruitingPhase 2
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum
RecruitingObservational study
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed
Peritoneal Carcinomatosis, Pseudomyxoma Peritonei
RecruitingObservational study
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
Appendix Cancer, Pseudomyxoma Peritonei
RecruitingPhase 2
Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeki Kusamura, MD PhD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytoreductive surgery, Low Intra abdominal pressure HIPEC and High Intra abdominal pressure HIPEC in people with Pseudomyxoma Peritonei and Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor tissue concentration of cisplatin (time frame: collected within 15 minutes after the completion of HIPEC). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949791, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.