Trial Outcomes & Findings for Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC (NCT NCT00238615)

Results Overview

Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Two years

Results posted on

2015-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel / Carboplatin / XRT + Surgical Resection Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=13 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 24 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Two years

Population: All patients alive and not censored at 2 years

Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.

Outcome measures

Outcome measures
Measure	Docetaxel / Carboplatin / XRT + Surgical Resection n=13 Participants All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint. Results were published PMID 21774104
2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.	7 participants

SECONDARY outcome

Timeframe: baseline, 5 weeks after combined chemo-radiation

Population: All enrolled patients were analyzed in the published manuscript

The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.

Outcome measures

Outcome measures
Measure	Docetaxel / Carboplatin / XRT + Surgical Resection n=13 Participants All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint. Results were published PMID 21774104
Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival	5.7 standardized uptake value (SUV)max Standard Deviation 5.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Specimen collected at time of surgery

Population: Plan was to analyze all patients with adequate tissue for this analysis, but was not done. We did not have sufficient funds for this analysis.

This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel / Carboplatin / XRT + Surgical Resection

Serious events: 8 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel / Carboplatin / XRT + Surgical Resection n=13 participants at risk Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720
Gastrointestinal disorders esophagitis	7.7% 1/13 • Number of events 1 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Respiratory, thoracic and mediastinal disorders respiratory infection	15.4% 2/13 • Number of events 2 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Blood and lymphatic system disorders anemia	15.4% 2/13 • Number of events 2 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Blood and lymphatic system disorders neutropenia	7.7% 1/13 • Number of events 2 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Injury, poisoning and procedural complications allergic reaction	15.4% 2/13 • Number of events 3 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
General disorders fatigue	30.8% 4/13 • Number of events 4 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Metabolism and nutrition disorders dehydration	7.7% 1/13 • Number of events 1 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Respiratory, thoracic and mediastinal disorders bronchopleural fistula	7.7% 1/13 • Number of events 1 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).

Other adverse events

Other adverse events
Measure	Docetaxel / Carboplatin / XRT + Surgical Resection n=13 participants at risk Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720
Blood and lymphatic system disorders anemia	15.4% 2/13 • Number of events 4 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
General disorders fatigue	38.5% 5/13 • Number of events 5 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Gastrointestinal disorders esophagitis	38.5% 5/13 • Number of events 5 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Respiratory, thoracic and mediastinal disorders pneumonitis	7.7% 1/13 • Number of events 1 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
Blood and lymphatic system disorders neutropenia	7.7% 1/13 • Number of events 1 • Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).

Additional Information

Dr. Heather Wakelee

Stanford University

Phone: 650-736-7221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place