C34.9
Conditions
Interventions
Group 1: Concurrent chemoradiotherapy regimens with PE (etoposide 50 mg/m² day 1 to day 5, day 29 to day 33 and cisplatin 50 mg/m² day 1, 8 and 29
radiotherapy- total dose: 4500 cGy in 25 fractions over 5 weeks
180 cGy/fraction)
Group 2: Concurrent chemoradiotherapy regimens with PC (paclitaxel 45mg/m² weekly over 1 hour and carbplatin AUC-2 weekly over 30 min (day 1, 8, 15, 22, 29)
180 cGy/fraction)
Sponsors
Oncology & Radiotherapy Centre, Square Hospitals Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria included Non-small cell lung cancer proved by pathology or cytology; inoperable AJCC stage IIIB prior to the initiation of treatment; age: 18 to 75; Eastern Cooperative Oncology Group (ECOG) performance status =2; lose of weight <10% during 6 months; biochemical tests values: WBC =3.5×109/L, neutrophils =1.5×109/L, platelets =100×109/L, 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; no serious diseases of important organs; written informed consent signed prior to enrollment.
Exclusion criteria
Exclusion criteria: Exclusion Criteria included pretreatment with radiotherapy, chemotherapy or biological agents; pregnant or lactating woman; serious diseases (include significant cardiovascular disease or uncontrolled diabetes) of important organs; other malignancies; active uncontrolled infection; joined in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What: Primary outcome- Overall Survival and Progression Free Survival When: Up to 1 year. One-year overall survival (OS) was calculated from the first day of treatment to death or the last follow up at 12 months. Progression-free survival (PFS) was calculated as the time from the initiation of treatment to disease progression (recurrence and/or distant metastases) or death upto 12 months. How: Overall survival and Progression-free survival were calculated by Kaplan-Meier Survival analysis method. Log-rank test was used to compare between the arms. Statistical correlation was done by SPSS software, version-22. A value of P less than 0.05 was considered statistically significant with confidence interval of 95%. The patients were undergone follow-up every 3 months for 1-year from hospital records and/or by phone. The follow-up evaluations were consisted of a history, physical examination, CBC, blood chemistries, thoracic x-ray and abdominal ultrasound at intervals of 3 months or earlier if clinically indicated. Other imaging and pathological confirmations were obtained if recurrence was suspected. | — |
Secondary
| Measure | Time frame |
|---|---|
| What: Second outcome- treatment response and treatment related acute and late toxicities. When: Treatment response were evaluated 6 weeks after completion of treatment. Acute toxicities were evaluated within 90 days of starting the treatment. Later toxicities were evaluated from 90 days to 1 year after starting the treatment. How: The treatment response evaluation was performed according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.09. Acute toxicities were evaluated based on the RTOG Acute Morbidity Criteria. Later toxicities were evaluated based on National Cancer Institute Common Toxicity Criteria Adverse Events (CTCAE), version 4.03. Student’s t-test, Chi-squared test and Fisher’s exact test were used to compare across the arms in different aspects. Statistical correlation was done by SPSS software, version-22. A value of P less than 0.05 was considered statistically significant with confidence interval of 95% for all analysis. Weekly undertreatment evaluations were consisted of history and physical examinations, documentation of ECOG Performance Status, CBC, electrolyte, creatinine, ALT and scoring of toxicities. After 6 weeks of completion of treatment, the patients were assessed for treatment response by physical examination, radiographic (CT scan) assessment and abdominal ultrasound. The patients were undergone follow-up every 3 months for 1-year from hospital records and/or by phone. The follow-up evaluations were consisted of a history, physical examination, CBC, blood chemistries, thoracic x-ray and abdominal ultrasound at intervals of 3 months or earlier if clinically indicated. | — |
Countries
Bangladesh
Contacts
Public ContactMd Shuayb
Oncology & Radiotherapy Centre, Square Hospitals Ltd.
Outcome results
None listed