Trial Outcomes & Findings for Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer (NCT NCT00193427)
NCT ID: NCT00193427
Last Updated: 2022-03-03
Results Overview
A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
18 months
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
Intervention
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=75 Participants
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
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Age, Continuous
|
62 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All patients who underwent a thoracotomy were assigned a pathologic response category.
A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.
Outcome measures
| Measure |
Intervention
n=38 Participants
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
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Pathologic Complete Response Rate
|
0 Percentage of participants
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SECONDARY outcome
Timeframe: 19 monthsPopulation: All patients were assessed for progression free survival after a median follow up of 19 months.
Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.
Outcome measures
| Measure |
Intervention
n=67 Participants
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
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Progression Free Survival (PFS)
|
9.9 Months
Interval 5.9 to 13.9
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SECONDARY outcome
Timeframe: 18 monthsPopulation: Patients who were assessable after completion of 9 weeks of treatment were evaluated and assigned a response category.
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Outcome measures
| Measure |
Intervention
n=67 Participants
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
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Overall Response Rate (ORR)
|
30 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for overall survival after a median follow-up of 19 months.
Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.
Outcome measures
| Measure |
Intervention
n=67 Participants
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
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Overall Survival (OS)
|
18 Months
Interval 14.8 to 21.3
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Adverse Events
Intervention
Serious events: 39 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=75 participants at risk
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
1.3%
1/75
|
|
Gastrointestinal disorders
Anorexia
|
1.3%
1/75
|
|
Cardiac disorders
Cardiac General - Other (Coronary Artery Disease)
|
1.3%
1/75
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.3%
1/75
|
|
Cardiac disorders
Cardiopulmonary arrest
|
1.3%
1/75
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
1.3%
1/75
|
|
Gastrointestinal disorders
Colitis
|
2.7%
2/75
|
|
General disorders
Death not associated with CTCAE term (Death NOS)
|
2.7%
2/75
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|
General disorders
Death not associated with CTCAE term (Disease Progression NOS)
|
5.3%
4/75
|
|
Gastrointestinal disorders
Dehydration
|
2.7%
2/75
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/75
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
2/75
|
|
Blood and lymphatic system disorders
Edema
|
1.3%
1/75
|
|
Infections and infestations
Febrile neutropenia
|
2.7%
2/75
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
1.3%
1/75
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/75
|
|
Infections and infestations
Infection - Other (bronchitis)
|
1.3%
1/75
|
|
Infections and infestations
Infection with normal ANC - Lung (pnemonia)
|
1.3%
1/75
|
|
Infections and infestations
Infection with unknown ANC - Lung (pnemonia)
|
4.0%
3/75
|
|
Surgical and medical procedures
Intra-operative injury - Heart
|
1.3%
1/75
|
|
Gastrointestinal disorders
Obstruction, GI - Bowel NOS
|
1.3%
1/75
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Acute respiratory failure)
|
2.7%
2/75
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Chronic Obstructive Pulmonary Disease)
|
5.3%
4/75
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.7%
2/75
|
Other adverse events
| Measure |
Intervention
n=75 participants at risk
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
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|---|---|
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Skin and subcutaneous tissue disorders
Alopecia
|
32.0%
24/75
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
50/75
|
|
Gastrointestinal disorders
Anorexia
|
42.7%
32/75
|
|
Psychiatric disorders
Mood alteration - anxiety
|
8.0%
6/75
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
10.7%
8/75
|
|
Gastrointestinal disorders
Constipation
|
29.3%
22/75
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
7/75
|
|
Gastrointestinal disorders
Dehydration
|
10.7%
8/75
|
|
Gastrointestinal disorders
dysphagia
|
9.3%
7/75
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
4/75
|
|
Blood and lymphatic system disorders
Edema
|
14.7%
11/75
|
|
Gastrointestinal disorders
Esophagitis
|
5.3%
4/75
|
|
General disorders
Fatigue
|
96.0%
72/75
|
|
General disorders
Fever
|
6.7%
5/75
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory
|
6.7%
5/75
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.0%
9/75
|
|
Cardiac disorders
Hypotension
|
6.7%
5/75
|
|
Infections and infestations
Infection
|
36.0%
27/75
|
|
General disorders
Insomnia
|
14.7%
11/75
|
|
Blood and lymphatic system disorders
Leukocytes
|
61.3%
46/75
|
|
Gastrointestinal disorders
Mucositis
|
13.3%
10/75
|
|
Musculoskeletal and connective tissue disorders
Pain - muscles
|
6.7%
5/75
|
|
Gastrointestinal disorders
Nausea
|
48.0%
36/75
|
|
Nervous system disorders
Neuropathy - sensory
|
8.0%
6/75
|
|
Blood and lymphatic system disorders
Neutrophils
|
52.0%
39/75
|
|
General disorders
Pain (NOS)
|
37.3%
28/75
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Symptoms
|
37.3%
28/75
|
|
Gastrointestinal disorders
Radiation esophagitis
|
18.7%
14/75
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
29.3%
22/75
|
|
Gastrointestinal disorders
Taste Alteration
|
9.3%
7/75
|
|
Blood and lymphatic system disorders
Platelets
|
68.0%
51/75
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
12/75
|
|
General disorders
Weight Loss
|
5.3%
4/75
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER