Malignant Pleural MesotheliomaNCT05508555
Effect of HITHOC After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma
A study testing hyperthermic intrathoracic chemotherapy in people with Malignant Pleural Mesothelioma and Chemotherapy Effect, run by Ain Shams University at 1 site in Egypt.
Trial summary
Malignant pleural mesothelioma (MPM) is an aggressive malignancy of the pleural lining with exceptionally poor survival. Median survival from diagnosis is less than 12 months (1). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Pleural Mesothelioma, Chemotherapy Effect
- What is being tested?
- hyperthermic intrathoracic chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Nov 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients presented with localised MPM are the main target and histopathological diagnosis of MPM is made via video-assisted thoracoscopic surgery or open multiple pleural biopsies.
Who cannot join
- patients with stage III or IV MPM in which cytoreductive surgery has no role.
- Patients underwent extrapleural pneumonectomy (EPP) as a cytoreductive surgery , because we are focusing on P/D only either conventional P/D or extended P/D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Hyperthermic Intrathoracic Chemotherapy After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma.
Malignant pleural mesothelioma (MPM) is an aggressive malignancy of the pleural lining with exceptionally poor survival. Median survival from diagnosis is less than 12 months (1). The widespread use of asbestos in past decades together with the long latency of MPM are responsible for the still increasing incidence of MPM (2), affecting 7-40 people per million inhabitants depending on the geographic region (3). The main therapeutic strategies for MPM are surgery, chemotherapy, and radiation therapy (RT). Multimodality treatment for MPM is a topic that has been attracting a lot of attention from researchers, as therapeutic modalities such as surgery, chemotherapy, or radiotherapy have not proven to be effective as single-modality treatments (4). surgery alone is not able to achieve microscopic complete (R0) resection. Therefore, combined treatment modalities have been established in many centres during the last years to achieve a better local tumor control with increasing overall survival (5). In this regard, hyperthermic intrathoracic or intrapleural chemotherapy has been used as one of the multimodality therapies. Intrapleural injection of cytotoxic drugs with hyperthermic perfusion has been proved to enhance cytotoxic effect on tumor cells with limited systemic side effect (6). While cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) has become a standard therapy for intraperitoneal original carcinoma or carcinomatosis peritonei such as pseudomyxoma and colorectal cancer induced ascites (7), limited studies have been reported on the application of hyperthermic intrathoracic chemotherapy (HITHOC) in combination with cytoreductive surgery for the treatment of the malignant pleural mesothelioma (8). With the application of the HITOC after macroscopic complete pleural tumour resection, it is expected to obtain better local tumour control, and thereby improve progression-free as well as overall survival (9).
In this study, we aim to compare results of HITHOC after P/D versus P/D alone in managing patients with localised MPM and our main outcomes are disease free survival, overall survival and possible perioperative complications.
Read the detailed description
Malignant pleural mesothelioma (MPM) is a fatal malignancy with limited options of therapies including surgery, radiotherapy and chemotherapy (10). extensive tumor extraction can be achieved with either extrapleural pneumonectomy (EPP) or extended pleurectomy/decortication (P/D. However, significant proportion of patients have relapse of the disease following EPP or P/D and they usually die within a few months (11). Thus, surgery-based multimodality therapies have been clinically explored in the past decades. Intraoperative intrapleural injection of cytotoxic drugs, such as cisplatin, doxorubicin, gemcitabine, or epirubicin, with hyperthermic perfusion at the time of surgery, i.e, hyperthermic intrathoracic chemotherapy (HITHOC), is a widely used method of multimodality treatment for MPM to optimize local disease control (12). The most popular cytotoxic drugs used for HITHOC were cisplatin followed by doxorubicin and mitomycin C, and 41-43 ◦C was most commonly used in HITHOC. The standard time for infusion was 60-90 min across the studies. Intrathoracic instillation of chemotherapeutic agents allows for a much higher concentration of the drug in the pleural cavity potentially improving the cytotoxic effect to the tumor cells and minimizing systemic adverse effects (13).
- Being tested
- hyperthermic intrathoracic chemotherapy
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperthermic intrathoracic chemotherapyProcedure or surgery
application of chemotherapeutic agent intrathoracic under hyperthermic conditions
| Study group | Role | What they receive |
|---|---|---|
| HITHOC group | Active comparator | the group that will receive HITHOC after pleurectomy decortication Receives: Procedure: hyperthermic intrathoracic chemotherapy |
| pleurectomy decortication without HITOC | No intervention | the group who received pleurectomy decortication without HITHOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival or time to recurrence
time from clearance of disease till onset of recurrence of same disease
Measured: Through out the whole study with maximum of 2 years
overall survival
survival of the cases till mortality
Measured: till mortality of the case or 2 years maximum
Secondary outcomes (1)
comorbidities
complications that may encounter either pre , intra or post intervention
Measured: Through out the whole study duration with maximum of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Mar 2022
- Primary completionMar 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hany Hassan El sayed, prof Dr., Study director, hanyhassan77@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508555
- Sponsor's protocol ID
- HITHOC after PD in MPM
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cao C, Tian D, Park J, Allan J, Pataky KA, Yan TD. A systematic review and meta-analysis of surgical treatments for malignant pleural mesothelioma. Lung Cancer. 2014 Feb;83(2):240-5. doi: 10.1016/j.lungcan.2013.11.026. Epub 2013 Dec 6.
PubMed 24360321Opitz I. Management of malignant pleural mesothelioma-The European experience. J Thorac Dis. 2014 May;6 Suppl 2(Suppl 2):S238-52. doi: 10.3978/j.issn.2072-1439.2014.05.03.
PubMed 24868442Friedberg JS, Simone CB 2nd, Culligan MJ, Barsky AR, Doucette A, McNulty S, Hahn SM, Alley E, Sterman DH, Glatstein E, Cengel KA. Extended Pleurectomy-Decortication-Based Treatment for Advanced Stage Epithelial Mesothelioma Yielding a Median Survival of Nearly Three Years. Ann Thorac Surg. 2017 Mar;103(3):912-919. doi: 10.1016/j.athoracsur.2016.08.071. Epub 2016 Nov 5.
PubMed 27825687Maziak DE, Gagliardi A, Haynes AE, Mackay JA, Evans WK; Cancer Care Ontario Program in Evidence-based Care Lung Cancer Disease Site Group. Surgical management of malignant pleural mesothelioma: a systematic review and evidence summary. Lung Cancer. 2005 May;48(2):157-69. doi: 10.1016/j.lungcan.2004.11.003. Epub 2005 Jan 5.
PubMed 15829316
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Hyperthermic Intrathoracic Chemotherapy After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma.
- ClinicalTrials.gov ID
- NCT05508555
- Acronym / sponsor ID
- HITHOC after PD in MPM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 19 Aug 2022 (actual)
- 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.
Malignant pleural mesothelioma (MPM) is an aggressive malignancy of the pleural lining with exceptionally poor survival. Median survival from diagnosis is less than 12 months (1). The widespread use of asbestos in past decades together with the long latency of MPM are responsible for the still increasing incidence of MPM (2), affecting 7-40 people per million inhabitants depending on the geographic region (3). The main therapeutic strategies for MPM are surgery, chemotherapy, and radiation therapy (RT). Multimodality treatment for MPM is a topic that has been attracting a lot of attention from researchers, as therapeutic modalities such as surgery, chemotherapy, or radiotherapy have not proven to be effective as single-modality treatments (4). surgery alone is not able to achieve microscopic complete (R0) resection. Therefore, combined treatment modalities have been established in many centres during the last years to achieve a better local tumor control with increasing overall survival (5). In this regard, hyperthermic intrathoracic or intrapleural chemotherapy has been used as one of the multimodality therapies. Intrapleural injection of cytotoxic drugs with hyperthermic perfusion has been proved to enhance cytotoxic effect on tumor cells with limited systemic side effect (6). While cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) has become a standard therapy for intraperitoneal original carcinoma or carcinomatosis peritonei such as pseudomyxoma and colorectal cancer induced ascites (7), limited studies have been reported on the application of hyperthermic intrathoracic chemotherapy (HITHOC) in combination with cytoreductive surgery for the treatment of the malignant pleural mesothelioma (8). With the application of the HITOC after macroscopic complete pleural tumour resection, it is expected to obtain better local tumour control, and thereby improve progression-free as well as overall survival (9).
In this study, we aim to compare results of HITHOC after P/D versus P/D alone in managing patients with localised MPM and our main outcomes are disease free survival, overall survival and possible perioperative complications.
Detailed description
Malignant pleural mesothelioma (MPM) is a fatal malignancy with limited options of therapies including surgery, radiotherapy and chemotherapy (10). extensive tumor extraction can be achieved with either extrapleural pneumonectomy (EPP) or extended pleurectomy/decortication (P/D. However, significant proportion of patients have relapse of the disease following EPP or P/D and they usually die within a few months (11). Thus, surgery-based multimodality therapies have been clinically explored in the past decades. Intraoperative intrapleural injection of cytotoxic drugs, such as cisplatin, doxorubicin, gemcitabine, or epirubicin, with hyperthermic perfusion at the time of surgery, i.e, hyperthermic intrathoracic chemotherapy (HITHOC), is a widely used method of multimodality treatment for MPM to optimize local disease control (12). The most popular cytotoxic drugs used for HITHOC were cisplatin followed by doxorubicin and mitomycin C, and 41-43 ◦C was most commonly used in HITHOC. The standard time for infusion was 60-90 min across the studies. Intrathoracic instillation of chemotherapeutic agents allows for a much higher concentration of the drug in the pleural cavity potentially improving the cytotoxic effect to the tumor cells and minimizing systemic adverse effects (13).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HITHOC group | Active comparator | Procedure: hyperthermic intrathoracic chemotherapythe group that will receive HITHOC after pleurectomy decortication |
| pleurectomy decortication without HITOC | No intervention | –the group who received pleurectomy decortication without HITHOC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients presented with localised MPM are the main target and histopathological diagnosis of MPM is made via video-assisted thoracoscopic surgery or open multiple pleural biopsies.
Key exclusion criteria (2 listed)
- patients with stage III or IV MPM in which cytoreductive surgery has no role.
- Patients underwent extrapleural pneumonectomy (EPP) as a cytoreductive surgery , because we are focusing on P/D only either conventional P/D or extended P/D
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 |
|---|---|---|
| hyperthermic intrathoracic chemotherapyapplication of chemotherapeutic agent intrathoracic under hyperthermic conditions | Procedure or surgery | HITHOC group |
Primary outcome
disease free survival or time to recurrence
Time frame: Through out the whole study with maximum of 2 years
time from clearance of disease till onset of recurrence of same disease
overall survival
Time frame: till mortality of the case or 2 years maximum
survival of the cases till mortality
1 secondary outcome
comorbidities
Time frame: Through out the whole study duration with maximum of two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 24360321Cao C, Tian D, Park J, Allan J, Pataky KA, Yan TD. A systematic review and meta-analysis of surgical treatments for malignant pleural mesothelioma. Lung Cancer. 2014 Feb;83(2):240-5. doi: 10.1016/j.lungcan.2013.11.026. Epub 2013 Dec 6.
- Background: PubMed 24868442Opitz I. Management of malignant pleural mesothelioma-The European experience. J Thorac Dis. 2014 May;6 Suppl 2(Suppl 2):S238-52. doi: 10.3978/j.issn.2072-1439.2014.05.03.
- Background: PubMed 27825687Friedberg JS, Simone CB 2nd, Culligan MJ, Barsky AR, Doucette A, McNulty S, Hahn SM, Alley E, Sterman DH, Glatstein E, Cengel KA. Extended Pleurectomy-Decortication-Based Treatment for Advanced Stage Epithelial Mesothelioma Yielding a Median Survival of Nearly Three Years. Ann Thorac Surg. 2017 Mar;103(3):912-919. doi: 10.1016/j.athoracsur.2016.08.071. Epub 2016 Nov 5.
- Background: PubMed 15829316Maziak DE, Gagliardi A, Haynes AE, Mackay JA, Evans WK; Cancer Care Ontario Program in Evidence-based Care Lung Cancer Disease Site Group. Surgical management of malignant pleural mesothelioma: a systematic review and evidence summary. Lung Cancer. 2005 May;48(2):157-69. doi: 10.1016/j.lungcan.2004.11.003. Epub 2005 Jan 5.
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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.
Hany Hassan El sayed, prof Dr. study director
hanyhassan77@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperthermic intrathoracic chemotherapy in people with Malignant Pleural Mesothelioma and Chemotherapy Effect, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. 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 Egypt. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazem Mohamed Youssef, M.S.C (01115449746, zomayoussef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival or time to recurrence (time frame: Through out the whole study with maximum of 2 years). 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 NCT05508555, which also lists 4 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 22 Aug 2022.