This study will enroll elderly patients with advanced non-small cell lung cancer who are at high risk of developing chemotherapy toxicity (side effects). Patients will receive treatment with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity will be compared in the two treatment groups to determine the best treatment strategy for this group of patients.
The primary objective of this trial is to compare the treatment failure-free survival rate in high-risk elderly patients, identified by geriatric assessment, treated with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel in advanced non-small cell lung cancer. Treatment failure-free survival is the most appropriate primary outcome as it captures excessive toxicity due to chemotherapy in addition to death and disease progression. The secondary objectives are to evaluate grade 3-5 toxicities, overall response rate, progression free survival, symptom assessment, and overall survival between the two randomization arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Yale Cancer Center
New Haven, Connecticut, United States
Treatment Failure-free Survival
Time frame: 90 days
Overall Response Rate
Time frame: start of treatment to disease progression/recurrence, up to 12 months
Progression-free Survival
Time frame: start of treatment to disease progression, up to 12 months
Overall Survival
Time frame: Up to 12 months
Grade 3-5 Adverse Events
Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Up to week 13
Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained.
Time frame: baseline
Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
The higher the score, the greater the symptoms. The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained. Symptoms were measured following 2 21-day cycles of chemotherapy.
Time frame: week 6
Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. Symptoms were measured following 4 21-day cycles of chemotherapy.
Time frame: week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.