CTRI/2020/03/023770招募中3 期
Carboplatin/ Paclitaxel Versus Cisplatin/ Etoposide as Definitive ChemoRadiotherapy for LocoRegionally advanced Non ââ?¬â?? Small Lung cancer (NSCLC): A Phase III Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ââ?°Â¥ 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 < 2.5 x ULN, serum bilirubin < 2 x ULN)
- •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.
排除标准
- •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.
研究者
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