Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Cisplatin and Etoposite with Radiotherapy: Concurrent chemotherapy will be etoposide 50 mg/m2 on days 1 to 5 and days 29 to 33 and cisplatin 50 mg/m2 on days 1, 8, 29 and 36, followed b
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologic or cytologic diagnosis of NSCLC (all histologies) 2.Stage III (IIIA/ IIIB/ IIIC) NSCLC, staged as per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 8th Edition (2017) 3.Disease is unresectable or inoperable; patient is not planned for surgery with curative intent. 4.Planned for radical chemoradiotherapy (CRT) 5.Age � 18 years 6.ECOG performance status (PS) 0-2 7.Adequate bone marrow function (hemoglobin > 8 g/L, platelets > 80 x 109/L, absolute neutrophil count (ANC) > 1.5 x 109/L) 8.Adequate liver function (ALT/ AST 9.Adequate renal function (creatinine clearance > 45 ml/ min, calculated by the Cockcroft-Gault formula, or by a nuclear medicine scan like a diethylenetriamine pentaacetic acid scan) 10.Women of childbearing potential must be willing to consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. A man who is the partner of a woman of childbearing potential must be willing to consent to using effective contraception (e.g., vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter. 11. Willing and able to comply with all study requirements, including treatment; able to follow-up at regular intervals. 12.Signed, written informed consent.
Exclusion criteria
Exclusion criteria: 1. Clinical or radiologic evidence of metastatic disease. 2. A patient has received prior thoracic radiotherapy. 3. Patient planned for hypofractionated radiotherapy. 4. Known hypersensitivity to paclitaxel, carboplatin, cisplatin or etoposide. 5. Evidence of clinical hearing loss or moderate to severe sensorineural hearing loss on audiometry. The presence of mild sensorineural loss or any degree of conductive hearing loss are not exclusion criteria. 6. Any significant active infection, including chronic active hepatitis B, active hepatitis C, HIV infection with AIDS or immunodeficiency syndromes. Testing for these is not mandatory unless clinically indicated. Participants with known hepatitis B/ C infection will be allowed to participate, provided evidence of viral suppression has been documented and the patient remains on appropriate antiviral therapy. 7. Serious uncontrolled medical illness (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, severe infection or untreated psychiatric conditions) that might limit the ability of the patient to comply with the protocol. 8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse. 9. History of malignancy other than NSCLC, except curatively treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or other malignancies curatively treated with no evidence of disease for over three years. Exceptions to this criterion will be permitted on a case-by-case basis, after discussion with the principal investigator, if it is determined that the patientââ?¬•s risk of disease recurrence or death from the earlier cancer is very low. 10. Use of an investigational agent within the preceding 30 days.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare Progression free survival 2.To asses toxicity 3 Resonse rate 4. Disease failure rate 5. Quality of lifeTimepoint: 1. At Progression 2. At Every Visit 3. At 8 to 12 weeks 4.At Progression 5. Baseline At the start of week 5 At completion of CRT | — |
Primary
| Measure | Time frame |
|---|---|
| To compare the overall survival (OS) of patientsTimepoint: At death | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed