Research on the safety of hyperthermic chemotherapy administered at the time of resection of disseminated lesions for pleural dissemination of malignant tumors occurring in children and AYA generations

JRCT ID: jRCTs031230736

Registered date:27/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pleural dissemination of malignant tumor
• Date of first enrollment: 27/03/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): pleural dissemination resection, intraoperative hyperthermic chemotherapy

Outcome(s)

Primary Outcome

1. Intraoperative and postoperative adverse events and complications
The primary endpoint will be DLT, and adverse events will be evaluated using CTCAE v5.0. With the exceptions listed below, clinically significant grade 3 or higher symptoms related to drug administration that occur within 28 days of starting this treatment (or 28 days after the second dose if bilateral). Toxicity is defined as DLT. However, regarding hematologic toxicity, a DLT is defined as a case where bone marrow function that meets the criteria for starting treatment does not recover even after one course (28 days). Surgical complications are also an important factor related to the safety of HITHOC, and surgical complications that require reoperation, such as air leaks, are also considered DLT.
Exception item
- Nausea, vomiting, fatigue, fever, and hair loss are not considered DLTs.
Infections including catheter-related infections, febrile neutropenia, and skin symptoms (erythroderma) of grade 4 or higher are considered DLTs.
- Abnormalities in test values that do not require treatment and do not affect the implementation of other treatments are considered to have no clinical significance and are not considered DLTs.
- Diarrhea of grade 3 or higher is considered a DLT. However, small amounts of defecation that stick to diapers, etc. and cannot be weighed are not included in the number of diarrhea cases.

Illnesses associated with surgery, etc. :Intraoperative and postoperative bleeding (lungs, pleura, wound), temporary drop in blood pressure due to heart compression with perfusate, wound infection, pneumonia, atelectasis, pneumothorax, pleural effusion, wound dehiscence

Diseases associated with heating inside the thoracic cavity; burns of organs such as the lungs, heart, large blood vessels, thymus gland, etc. due to accidental overheating

As safety evaluation items, we will collect Grade 3 or higher medical adverse events (hereinafter referred to as diseases, etc.*) that occur in research subjects as a result of participating in clinical research. The principal investigator or research sub-physician shall evaluate the extent, causal relationship, and severity of the disease, etc. by applying mutatis mutandis 10.2. , the date of onset, details of treatment/treatment, and outcome (time of recovery if the patient has recovered, and time of recovery if the symptoms have stabilized).

Secondary Outcome

Survival status after 3, 6, and 12 months
Disease remission after 3, 6, and 12 months

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 22age old
• Gender: Both

Include criteria

(1) Patients aged 12 to 22 years at the time of diagnosis of pleural dissemination
(2) Patients with dissemination to only one side of the pleura (excluding cases of bilateral dissemination)
(3) Patients diagnosed with pleural dissemination of malignant tumor in children/AYA generation
(4) The tumor is sensitive to CDDP
(5) Patients who meet certain criteria in various clinical tests
(6) No uncontrollable infections.
(7) Patients who have obtained written consent from themselves or their legal guardian regarding participation in this study.

Exclude criteria

(1) PD: When pleural dissemination or increased lung metastasis is observed in the most recent two consecutive chest CT scans taken approximately one month apart.
(2) When the primary tumor remains in a viable state as assessed by MRI or FDG-PET, or when new metastasis is observed in areas other than the lungs and pleura.
(3) Patients whose respiratory function is considered intolerant to thoracotomy
(4) Patients for whom cisplatin use is contraindicated
(5) Women who are pregnant, breastfeeding, may be pregnant, or wish to become pregnant during the treatment period, and men who wish their partner to become pregnant.
(6) Other patients who are judged to be inappropriate by the doctor's judgment
(7) Patients within 2 weeks of completion of systemic chemotherapy for malignant disease
(8) Participating in other clinical trials or clinical research

Related Information

• Primary Sponsor: Kitagawa Norihiko