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NCT01836575 · ClinicalTrials.gov registry record · Phase 3
Alimta® Versus Its Combination With Carboplatin in Advanced Non-small-cell Lung Cancer in Patients Performance Status 2
A Phase 3 study of Non-Small-Cell Lung Carcinoma, sponsored by Instituto Nacional de Cancer, Brazil.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
- 9
- Study locations
NCT01836575 is a Phase 3 study of Non-Small-Cell Lung Carcinoma that has completed, run by Instituto Nacional de Cancer, Brazil. The registered enrollment target is 228 participants, roughly in line with the 228-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target. The trial reports 9 study locations across 7 states.
The verdict
NCT01836575, a Phase 3 study of Non-Small-Cell Lung Carcinoma, has completed, sponsored by Instituto Nacional de Cancer, Brazil.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
- 9
- Study locations
Study Summary
Optimal management of patients with advanced NSCLC and with PS 2 remains controversial and underrepresented in clinical trials, typically accounting for 5 to 10% of enrolled patients. Patient PS 2 proportion in population-based studies is considerably higher than that included in clinical trials. Management of patients with PS of 2 in clinical practice is empirical and inconsistent. Patients have median overall survival of 3 to 5 months in randomized trials, and treatment options include best supportive care, single-agent and combination chemotherapy. Retrospective studies have suggested that patients PS 2 may benefit from first-line chemotherapy in terms of symptom improvement and overall survival. In many of these studies, single-agent chemotherapy was compared with best supportive care alone. Data on the role of cisplatin-based combinations for patients with PS 2 is more scant, with one study questioning its benefit, and another interrupting accrual because of undue toxicity. With regards to carboplatin, the Cancer and Leukemia Group B (CALGB) study 9730 compared paclitaxel plus carboplatin versus paclitaxel alone in a subgroup of 107 patients with PS 2; the median overall survival was significantly longer in group treated with combination chemotherapy (4.7 versus 2.4 months). Combination chemotherapy with carboplatin and paclitaxel also produced a statistically significantly higher incidence of severe hematological and non-hematological toxicities. On the basis of aforementioned results, a recent European panel stated that carboplatin-based or low-dose cisplatin-based doublets might represent alternative options to single-agent chemoterapy in patients PS 2. Outside clinical trials, single-agent chemotherapy with a 3rd generation agent remains valid option for patients PS2. Results demonstrate that pemetrexed is an agent with established single-agent activity in NSCLC, and suggest it is a potential candidate for combinations with platinum and other agents current
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
Study Locations (9)
Rio Grande do Sul
- Hospital Caridade de Ijuí - CACON - Ijuí
- Hospital São Lucas - Porto Alegre
São Paulo
- Hospital Amaral Carvalho - Jaú
- Instituto do Câncer Arnaldo Vieira de Carvalho - São Paulo
Florida
- The Mount Sinai Comprehensive Cancer Center - Miami Beach
Ceará
- Instituto do Câncer do Ceará - ICC - Fortaleza
Minas Gerais
- Hospital Lifecenter - Belo Horizonte
Rio de Janeiro
- INCA - Rio de Janeiro
Santa Catarina
- Centro de Pesquisas Oncológicas - CEPON - Florianópolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01836575
The ClinicalTrials.gov registry entry for NCT01836575 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 228-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target. The listed sponsor is Instituto Nacional de Cancer, Brazil, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Carboplatin is the first listed.
NCT01836575 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Rio Grande do Sul, São Paulo, Florida.
Frequently Asked Questions
What is clinical trial NCT01836575 about?
NCT01836575 is a clinical study titled "Alimta® Versus Its Combination With Carboplatin in Advanced Non-small-cell Lung Cancer in Patients Performance Status 2". Optimal management of patients with advanced NSCLC and with PS 2 remains controversial and underrepresented in clinical trials, typically accounting for 5 to 10% of enrolled patients. Patient PS 2 proportion in population-based studies is considerably higher than that included in clinical trials. Ma...
What is the current status of trial NCT01836575?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2008-04. Estimated completion is 2012-12.
What conditions does trial NCT01836575 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma.
What interventions are being tested in trial NCT01836575?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT01836575?
This trial is sponsored by Instituto Nacional de Cancer, Brazil, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01836575 being conducted?
This trial has 9 study locations across Florida, Ceará, Minas Gerais, Rio de Janeiro, Rio Grande do Sul. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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