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

NCT03092986 | Completed Phase 4 DMC

• 1 other identifier: BangabandhuONCOLOGY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• tumor response

  complete response(CR), partial response(PR), progressive disease(PD) and stable disease(SD),Responses Description Complete Response ( CR ) Disappearance of all known diseases, confirmed at ≥ 4 weeks. Partial Response ( PR ) ≥ 50 % decrease from baseline, confirmed at ≥ 4 weeks. Progressive disease ( PD ) ≥ 25 % increase in one or more lesions or appearance of new lesions Stable disease ( SD ) Neither PR or PD criteria met final tumor response will be seen in 30 weeks of starting of completion and will be considered as the primary outcome

  30 weeks

Study Arms (2)

chemotherapy with paclitaxel and carboplatin

ACTIVE COMPARATOR

Intervention: paclitaxel 200 mg/m2 AUC and carboplatin AUC 6 on day 1 every 3 wks for 2 cycles followed by three dimensional conformal radiotherapy on day 42

Drug: Paclitaxel; Drug: Carboplatin; Radiation: three dimensional conformal radiotherapy

chemotherapy with cisplatin and vinblastine

EXPERIMENTAL

Intervention : cisplatin 100 mg/m2 on day 1 and 29 and vinblastine 5mg/m2 on days 1,8,15,22 and 29 followed by three dimensional conformal radiotherapy on day 50

Drug: Cisplatin; Drug: Vinblastine Sulfate; Radiation: three dimensional conformal radiotherapy

Interventions

Paclitaxel DRUG

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

Also known as: Xelpac

chemotherapy with paclitaxel and carboplatin

Carboplatin DRUG

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

Also known as: carboplat

chemotherapy with paclitaxel and carboplatin

Cisplatin DRUG

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

Also known as: Platinex

chemotherapy with cisplatin and vinblastine

Vinblastine Sulfate DRUG

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

Also known as: Velvin

chemotherapy with cisplatin and vinblastine

three dimensional conformal radiotherapy RADIATION

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

chemotherapy with cisplatin and vinblastine; chemotherapy with paclitaxel and carboplatin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Department of Oncology,Bangabandhu Sheikh Mujib Medical university

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Carboplatin; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Vinblastine; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Oncology program Phase B Resident Doctor,Department of Oncology,Principal investigator.

Model Details: Randomized Controlled type, 60 patients randomized with help of randomized number generator in two arms, Arm A and Arm B, each with at least 30 number of patients, research material will be data collection form,Arm A will receive paclitaxel 200 mg/m2 i.v over 3 hrs on D1; carboplatin AUC 6 i.v over 60 minutes on D1 every 3 wks for 2 cycles followed by radiotherapy with 6000 c Gy given in 30 fractions beginning on day 42 , Arm B willl receive - cisplatin (100 mg/m2 BSA i.v over 2 hrs. on days 1 and 29) and vinblastine (5 mg/m2 BSA i.v rapidly push weekly on days 1,8,15,22 and 29) followed by radiotherapy with 6000 cGy given in 30 fractions beginning on day 50 ,data will be analysed and interpreted and result will be drawn on basis of outcome measures which is again based on tumor response RECIST criteria

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)