Phase III non-inferiority randomized trial comparing three-weekly Cisplatin versus weekly Cisplatin in combination with radiation therapy in patients with advanced carcinoma of the head and neck

Tata memorial Hospital Mumbai0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•. Histological or cytological proven diagnosis of squamous cell or undifferentiated carcinoma of the oropharynx, hypopharynx and larynx or squamous cell carcinoma of the head and neck region of unknown primary.
•3. Disease is Stage III or IV, with no evidence of distant metastases.
•4. ECOG performance status <= 2
•5. Patients who are candidates for adjuvant concurrent chemoradiotherapy, i.e. tumor histopathology demonstrates close or positive margins, perinodal extension, > 2 lymph nodes positive or T4 primary.
•6. Patients with no contraindications to Cisplatin chemotherapy.
•7. Patients with no contraindications to radiotherapy.
•8. Patients who can give informed consent to participate in the study.
•9. Patients who can be followed up and can take all the cycles of chemotherapy at the participating institution.
•10. Adequate organ function
•Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
•Liver functions- bilirubin <= 2 x upper limit normal (ULN), AST/ALT/ ALP <= 2.5 x ULN, S. albumin >= 30 g/L.
•Renal function- Creatinine <= 1.5 ULN, Creatinine clearance > 50 mL/min.
•11. Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

•1. Baseline hearing loss,which is moderate or severe.2) Calculated GFR 50 cc/min.3) Patients who have received any neoadjuvant induction chemotherapy 4) Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infection.5) Presence of distant metastatic disease .6) Life expectancy less than 6months.7) Patient with active second malignancies ,apat from skin cancers and cervical intraepithelial neoplasia.8) Patient on other investigatonal

发起方

Tata memorial Hospital Mumbai