Intratumoral Hyperthermic Chemotherapy Injection in Peripheral Non-Small Cell Lung Cancer; Efficacy and Safety

Not Applicable

Recruiting

• Conditions: lung cancer; Cancer

• Registration Number: PACTR201702001974160
• Lead Sponsor: faculty of medicine,Mansoura university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients with peripheral lung cancer planned to be treated by chemotherapy who include all of the following:
1-Histologically-diagnosed, peripheral NSCLC.
2-Patients who are not candidate for surgical treatment because of poor cardiopulmonary status, inoperable advanced stage of lung cancer or refusal of surgery
3-The patients are fit for chemotherapy with adequate bone marrow reserve:
¿White blood cell count >3500/mm3.
¿Neutrophil count >1800/mm3.
¿Hemoglobin >10 gm /dL.
¿Haematocrit value >30%

Exclusion Criteria

Patients with one or more of the following will be excluded:
1.Patient is operable and planned for surgery.
2.Tumors infiltrating the main stem bronchi, trachea and/or mediastinum as detected by fiberoptic bronchoscopy (FOB) and or CT chest (central bronchogenic carcinoma).
3.Uncooperative patients.
4.Patient with uncorrectable bleeding diathesis.
5.Lung cancer other than NSCLC (small cell lung cancer, metastatic lung cancer, lymphoma, sarcoma, others ).
6.Platelet count ¿ 50,000 mm3 and/or prothrombin time ¿ 50%.
7.Serum bilirubin more than 2.5 mg/dL, ALT and AST > 3 times normal level and creatinine > 1.5 mg/dL.
8.Patient with severe pulmonary dysfunction.
9.Patient with uncompensated cardiac comorbidities.
10. Hypersensitivity to cisplatin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A. Clinical evaluation: It depends on recording the changes in patients¿ symptoms, performance status, and quality of life. B. Radiological evaluation will be done by: Chest X-ray and CT of the chest. C. Histopathological examination by tru cut biopsy after 6 months.

Secondary Outcome Measures

Name	Time	Method
survival