This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS).
This is a safety and feasibility study of repeated (minimum two procedures) PITAC directed treatments, and the primary outcome is the number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) and/or surgical complications according to the Clavien-Dindo classification. This study will include consecutive MPE patients until 20 patients have completed at least two PITAC´s. The PITAC directed treatment will be performed in 4 week intervals. Bedside ultrasound, VAS-pain and VAS-breathlessness, and Quality of Life questionnaires will be performed at baseline, one month follow-up and three months follow-up. Patients with MPE who are eligible for surgery are identified during the multidisciplinary tumor (MDT) conference at the Department of Surgery, Odense University Hospital (OUH), and included based on predefined in- and exclusion criteria. Patients with MPE from non-colorectal or -appendix cancer will be treated with a combination of cisplatin and doxorubicin. Patients with MPE from colorectal or appendix cancer will be treated with oxaliplatin. In brief, The PITAC procedure is the application of aerosolized chemotherapy into the pleural cavity using thoracoscopy. PITAC is performed in the prone or lateral position. A double lumen endotracheal tube is used to allow exclusion of the ipsilateral lung, but this is not (always) necessary with the patient in the prone position. The first trocar is placed guided by ultrasound, and after safe positioning a second trocar can be inserted guided by video thoracoscopy. The chemotherapy is applied to the pleural cavity through a nebulizer inserted through one of the trocars and linked to a high-pressure injector. After five minutes the chemotherapy has been delivered to the pleural cavity, and after an additional 30 minutes of simple diffusion, the intrathoracic air saturated with chemotherapy is evacuated through a series of filters. The patients are monitored for a minimum of one day and will after each PITAC directed treatment be screened for adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Cisplatin, oxaliplatin and doxorubicin are standard, commercially available intravenous cytostatic drugs in oncologic treatment with alkylating and topoisomerase inhibitor effect, respectively. Based on the available data and experience from 11 PITAC procedures at OPC, PITAC with cisplatin, oxaliplatin and doxorubicin for intrapleural administration is expected to be well tolerated with a minimal of nausea, subcutaneous emphysema and transient chest pains.
Odense PIPAC Center, Department of Surgery, Odense University Hospital
Odense, Denmark
RECRUITINGMedical adverse events
Number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 defined as CTCAE ≥ 4 within 30 days after the procedure.
Time frame: 30 days from PITAC directed treatment
Surgical complications
Number of patients with surgical complications according to the Clavien-Dindo classification defined as Clavien-Dindo ≥ 3b within 30 days after the procedure.
Time frame: 30 days from PITAC directed treatment
Number of patients completing three PITAC treatments
To evaluate the number of patients completing three PITAC treatments
Time frame: 12 months
Extent of visible pleural metastasis
To macroscopically evaluate the extent of visible pleural metastasis (PLM) during PITAC directed therapy via the new PLM-score based on size of lesions (LS). LS 0 No tumor seen LS1 Tumor up to 0.5 cm LS2 Tumor up to 5.0 cm LS3 Tumor \> 5.0 cm or confluence
Time frame: 12 months
Pathology on pleural metastasis biopsies
To evaluate Pleural Regression Grade Score (Ple-RGS) in biopsies from visible pleural metastasis Ple-RGS is a modification of the Peritoneal Regression Grading score (PRGS). Ple-RGS 1: Complete histological response Ple-RGS 2: Regressive changes are predominant over cancer cells (major response) Ple-RGS 3: Cancer cells are predominant over regressive changes (minor response) Ple-RGS 4: No response
Time frame: 12 months
Cytology on malignant pleural effusion fluid
To evaluate cytology on MPE during PITAC directed therapy. The cells will be graded according to a five-tiered score: malignant cells, suspicious cells, atypical cells, no malignant cells and other
Time frame: 12 months
LENT score
To evaluate the LENT score after each PITAC directed therapy. Low risk: 0-1 Moderate risk: 2-4 High risk: 5-7
Time frame: 12 months
Length of Stay (LOS)
Quantify the length of stay (LOS) (surgery = day 0)
Time frame: 12 months
Personnel safety (environmental)
Assess personnel safety by measuring of platinum traces in the operating room.
Time frame: 12 months
Personnel safety (biological)
Assess personnel safety by measuring of platinum traces in blood samples from surgeons and/or OR nurses.
Time frame: 12 months
Lung function evaluation by SAT
To evaluate lung function by saturation (SAT) before PITAC directed treatment (day 0) and at discharge (day 1), day 30 and 3 months after the last PITAC directed treatment
Time frame: 12 months
Breathlessness
To evaluate breathlessness using visual analogue scales (VAS-breath) before PITAC directed treatment (day 0) and at discharge (day 1), day 30, and 3 months after the last PITAC directed treatment
Time frame: 12 months
Pain assessment
To evaluate pain using visual analogue scales (VAS-pain) before PITAC directed treatment (day 0) and at discharge (day 1), day 30, and 3 months after the last PITAC directed treatment
Time frame: 12 months
Quality of Life questionnaires
To evaluate the quality of life with EORTC-QLQ-C30 at baseline, day 30 and 3 months after the last PITAC directed treatment
Time frame: 12 months
Change in MPE volume
To calculate the change in volume of drained MPE from 2 months before the first PITAC treatment to three months after the last PITAC treatment
Time frame: 12 months
Long term complications
To assess long-term complications 3 months after the third PITAC directed treatment
Time frame: 12 months
Survival
Median overall survival
Time frame: 12 months
Lung function evaluation by FEV1
To evaluate lung function by Forced Expired Volume in the first second (FEV1) before PITAC directed treatment (day 0) and at discharge (day 1), day 30 and 3 months after the last PITAC directed treatment
Time frame: 12 months
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