C76.0
Conditions
Interventions
Group 1: Concurrent chemoradiotherapy regimens with CDDP (cisplatin 30mg/m² weekly with premedications and adequate hydration
radiotherapy- 6600-7000 cGy in single daily 1.8-2 Gy/fraction, 5 days a week on linear accelerator with 4 or 6 MV photon beams)
Group 2: Concurrent chemoradiotherapy regimens with PC (paclitaxel 40mg
radiotherapy- 6600-7000 cGy in single daily 1.8-2 Gy/fraction, 5 days a week on linear accelerator with 4 or 6 MV photon beams)
Sponsors
Dr. Md Shuayb, MBBS, MSc, FCPS, Specialist, Oncology & Radiotherapy Centre, Square Hospitals Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) SCCHN proved by histopathology. 2) AJCC stage-III, IVA and IVB. 3) Age: 18 to 75. 4) Eastern Cooperative Oncology Group (ECOG) performance status = 2. 5) Biochemical tests values: WBC= 3.5×10^9/L, Neutrophils =1.5×10^9/L, Platelets =100×10^9/L, haemoglobin =9gm/dl, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin =1.5×the upper limit of the institutional normal range, Creatinine concentration=120 umol/L, and creatinine clearance =50 ml/min. 6) No serious diseases of important organs. 7) Written informed consent signed prior to enrollment.
Exclusion criteria
Exclusion criteria: 1) Prior chemotherapy or head & neck irradiation, 2) Pregnant or lactating woman, 3) Serious diseases (include significant cardiovascular disease or uncontrolled diabetes) of important organs, 4) Other malignancies, 5) Active uncontrolled infection, 6) Joined in other clinical trial, 7) Stage IVB with cricoid cartilage invasion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| What: Acute toxicities When: Weekly during treatment and 6 weeks after completion of treatment. How: Acute toxicities of the two regimens will be evaluated by determining the frequency of severe (= grade 3) toxicities based on RTOG Acute Radiation Morbidity Criteria using the information of history and physical examinations, ECOG performance status, CBC, electrolyte, creatinine, SGPT. | — |
Primary
| Measure | Time frame |
|---|---|
| What: Treatment Response When: 6 weeks after completion of Treatment How: The treatment response evaluation will be performed according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1 as Complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) using the data of Panendoscopic evaluation and CT scans of neck & face obtained 6 weeks after therapy. Pathologic confirmation will be required for patients suspected to have clinical evidence of residual disease at the primary site 6 weeks after therapy. | — |
Countries
Bangladesh
Contacts
Public ContactMd Shuayb
Dr. Md Shuayb, MBBS, MSc, FCPS, Specialist, Oncology & Radiotherapy Centre, Square Hospitals Ltd.
Outcome results
None listed