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

NCT03092986 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-03-08

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Paclitaxel

paclitaxel 200 mg/m2 i.v over 3 hrs on day 1, every 21 days for 2 cycles followed by radiotherapy on day 42

DRUG

Carboplatin

carboplatin AUC 6 iv over 1 hr on day 1 , every 212 days for 2 cycle followed by radiotherapy on day 42

DRUG

Cisplatin

cisplatin 100 mg/m2 i.v over 2 hrs on day 1 and 29 followed by radiotherapy on day 50

DRUG

Vinblastine Sulfate

Vinblastin 5mg/m2 i.v on day 1,8,15,22 and 29 followed by radiotherapy on day 50

RADIATION

three dimensional conformal radiotherapy

three dimensional conformal radiotherapy would be given at day 42 after completion of paclitaxel and carboplatin 2 cycle and at day 50 after completion of cisplatin and vinblastin from d1 to d29

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-06-01
Completion
2018-12-31

Countries

  • Bangladesh

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092986 on ClinicalTrials.gov