Trial Outcomes & Findings for Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer (NCT NCT00863512)

Last Updated: 2017-03-27

Results Overview

Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

Up to 12 years

Results posted on

2017-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Chemotherapy) Patients receive cisplatin 75 mg/m\^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m\^2 by IV on days 1 and 8 OR docetaxel 75 mg/m\^2 by IV and cisplatin 75 mg/m\^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m\^2 by IV on days 1 and 8 and cisplatin 75 mg/m\^2 by IV on day 1 OR pemetrexed disodium 500 mg/m\^2 by IV and 75 mg/m\^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Observation) Patients receive standard care (observation).
Overall Study STARTED	17	17
Overall Study COMPLETED	3	17
Overall Study NOT COMPLETED	14	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Chemotherapy) Patients receive cisplatin 75 mg/m\^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m\^2 by IV on days 1 and 8 OR docetaxel 75 mg/m\^2 by IV and cisplatin 75 mg/m\^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m\^2 by IV on days 1 and 8 and cisplatin 75 mg/m\^2 by IV on day 1 OR pemetrexed disodium 500 mg/m\^2 by IV and 75 mg/m\^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Observation) Patients receive standard care (observation).
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	11	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Chemotherapy) n=17 Participants Patients receive cisplatin 75 mg/m\^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m\^2 by IV on days 1 and 8 OR docetaxel 75 mg/m\^2 by IV and cisplatin 75 mg/m\^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m\^2 by IV on days 1 and 8 and cisplatin 75 mg/m\^2 by IV on day 1 OR pemetrexed disodium 500 mg/m\^2 by IV and 75 mg/m\^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Observation) n=17 Participants Patients receive standard care (observation).	Total n=34 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	63 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 years

Population: Study terminated prematurely with 34 participants recruited. Per protocol, 338 events were needed to conduct the primary analysis; therefore, the planned analyses was not performed due to a lack of events and a termination of data collection.

Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

Adverse Events

Arm II (Observation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm I (Chemotherapy)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm II (Observation) Patients receive standard care (observation).	Arm I (Chemotherapy) n=8 participants at risk Patients receive cisplatin 75 mg/m\^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m\^2 by IV on days 1 and 8 OR docetaxel 75 mg/m\^2 by IV and cisplatin 75 mg/m\^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m\^2 by IV on days 1 and 8 and cisplatin 75 mg/m\^2 by IV on day 1 OR pemetrexed disodium 500 mg/m\^2 by IV and 75 mg/m\^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Febrile neutropenia	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Cardiac disorders Sinus tachycardia	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Eye disorders Eye disorders - Other, specify	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Gastrointestinal disorders Mucositis oral	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Gastrointestinal disorders Nausea	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Infections and infestations Infections and infestations - Other, specify	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Metabolism and nutrition disorders Hypokalemia	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Metabolism and nutrition disorders Hypophosphatemia	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Nervous system disorders Nervous system disorders - Other, specify	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Vascular disorders Hypertension	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Vascular disorders Hypotension	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.

Other adverse events

Additional Information

David Harpole, M.D.

Duke University Medical Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm II (Observation) Patients receive standard care (observation).	Arm I (Chemotherapy) n=8 participants at risk Patients receive cisplatin 75 mg/m\^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m\^2 by IV on days 1 and 8 OR docetaxel 75 mg/m\^2 by IV and cisplatin 75 mg/m\^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m\^2 by IV on days 1 and 8 and cisplatin 75 mg/m\^2 by IV on day 1 OR pemetrexed disodium 500 mg/m\^2 by IV and 75 mg/m\^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Ear and labyrinth disorders Hearing impaired	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 5 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Gastrointestinal disorders Mucositis oral	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	25.0% 2/8 • Number of events 2 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Gastrointestinal disorders Nausea	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 5 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Gastrointestinal disorders Vomiting	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
General disorders Fatigue	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Investigations Creatinine increased	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 4 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Investigations Investigations - Other, specify	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Investigations Platelet count decreased	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Metabolism and nutrition disorders Anorexia	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	37.5% 3/8 • Number of events 6 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Musculoskeletal and connective tissue disorders Arthralgia	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 3 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Musculoskeletal and connective tissue disorders Myalgia	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	25.0% 2/8 • Number of events 2 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Musculoskeletal and connective tissue disorders Pain in extremity	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Nervous system disorders Peripheral motor neuropathy	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 1 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Respiratory, thoracic and mediastinal disorders Dyspnea	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	25.0% 2/8 • Number of events 5 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
Respiratory, thoracic and mediastinal disorders Pleural effusion	— 0/0 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.	12.5% 1/8 • Number of events 3 Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.