Outcome of Cisplatin and Vinblastine Versus Paclitaxel and Carboplatin as Sequential Chemotherapy Followed by Radiotherapy in Locally Advanced Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Lung cancer is the leading malignancy worldwide and in Bangladesh. Most of the lung cancer is of Non-small Cell Lung Cancer (NSCLC) type. For locally advanced NSCLC, combined modality treatment is required. Concurrent chemo-radiotherapy and sequential chemo-radiotherapy are the two recommended options. Sequential chemo-radiotherapy is mainly practiced in Bangladesh due to its less toxicity profile. There is no head to head comparative study done which focuses on the sequential chemotherapy regimens used in locally advanced NSCLC.

Hypothesis:

Null Hypothesis (H0): Sequential chemotherapy with cisplatin and vinblastine followed by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally advanced NSCLC, there is no difference in loco-regional tumor control.

Alternative Hypothesis (HA): Sequential chemotherapy with cisplatin and vinblastine followed by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally advanced NSCLC, cisplatin and vinblastine is more responsive and effective in loco-regional tumor control than paclitaxel and carboplatin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel; Vinblastine

Criteria

Inclusion Criteria:

• • Patients with locally advanced (stage III a, b) non-small cell lung cancer.

• Patients who are inoperable. Patients Eastern Co-operative Group (ECOG) performance score up to grade 2.

Exclusion Criteria:

• • Age below 18 years.

• Patients with history of prior chemotherapy or radiotherapy to lung region.

• Serious concomitant medical illness including severe heart disease, uncontrolled diabetes mellitus or hypertension.

• Life expectancy < 6 months.

• Patient with uncontrolled infection

• Pregnant or lactating woman.

• Psychiatric illness.