Trial Outcomes & Findings for Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer (NCT NCT00192036)
NCT ID: NCT00192036
Last Updated: 2010-12-09
Results Overview
Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
COMPLETED
PHASE2
49 participants
baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)
2010-12-09
Participant Flow
Participant milestones
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Patient/Physician Perception
|
1
|
|
Overall Study
Objective Tumor Progression
|
4
|
|
Overall Study
Clinical Disease Progression
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Unknown or Not Specified
|
5
|
Baseline Characteristics
Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine + Cisplatin
n=49 Participants
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Age Continuous
|
63.1 years
STANDARD_DEVIATION 8.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
49 participants
n=5 Participants
|
|
Basis for Pathological Diagnosis
Histopathological
|
39 participants
n=5 Participants
|
|
Basis for Pathological Diagnosis
Cytological
|
10 participants
n=5 Participants
|
|
Disease Stage
Stage IIIA
|
14 participants
n=5 Participants
|
|
Disease Stage
Stage IIIB
|
35 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
80 - Activity with effort; some signs of disease
|
9 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
90 - Normal activity; minor signs of disease
|
24 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
100 - Normal no complaints; no evidence of disease
|
16 participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma of Lung
|
18 participants
n=5 Participants
|
|
Pathological Diagnosis
Large Cell
|
7 participants
n=5 Participants
|
|
Pathological Diagnosis
Other Pathological Diagnosis
|
2 participants
n=5 Participants
|
|
Pathological Diagnosis
Squamous Cell
|
22 participants
n=5 Participants
|
|
Time Since Diagnosis
|
0.5 months
STANDARD_DEVIATION 0.25 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)Population: All enrolled participants.
Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=49 Participants
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Tumor Response at End of Treatment
Complete Response
|
1 participants
|
|
Tumor Response at End of Treatment
Partial Response
|
18 participants
|
|
Tumor Response at End of Treatment
Stable Disease
|
3 participants
|
|
Tumor Response at End of Treatment
Progressive Disease
|
1 participants
|
|
Tumor Response at End of Treatment
Unknown
|
22 participants
|
|
Tumor Response at End of Treatment
Missing
|
4 participants
|
SECONDARY outcome
Timeframe: Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);Population: All enrolled participants.
Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=49 Participants
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Time to Progressive Disease
Preliminary
|
10.9 months
Interval 0.9 to 39.2
|
|
Time to Progressive Disease
Final
|
11.4 months
Interval 9.4 to 12.9
|
SECONDARY outcome
Timeframe: Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)Population: All enrolled participants.
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=49 Participants
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Overall Survival
Preliminary
|
27.9 months
Interval 0.9 to 39.2
|
|
Overall Survival
Final
|
21.8 months
Interval 17.5 to 26.0
|
SECONDARY outcome
Timeframe: every cycle (21 days) for 3 cycles (up to 10 weeks)Population: All enrolled participants.
A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=49 Participants
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Safety of Induction Chemotherapy
Neutropenia - Grade 3
|
9 participants
|
|
Safety of Induction Chemotherapy
Neutropenia - Grade 4
|
8 participants
|
|
Safety of Induction Chemotherapy
Thrombocytopenia - Grade 3
|
4 participants
|
|
Safety of Induction Chemotherapy
Thrombocytopenia - Grade 4
|
1 participants
|
SECONDARY outcome
Timeframe: Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapyPopulation: All enrolled participants receiving chemo-radiotherapy (Cycle 4).
A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=49 Participants
Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
|
|---|---|
|
Safety of Chemo-radiotherapy
Neutropenia - Grade 3
|
6 participants
|
|
Safety of Chemo-radiotherapy
Neutropenia - Grade 4
|
2 participants
|
|
Safety of Chemo-radiotherapy
Thrombocytopenia - Grade 3
|
7 participants
|
|
Safety of Chemo-radiotherapy
Thrombocytopenia - Grade 4
|
1 participants
|
|
Safety of Chemo-radiotherapy
Radiation Esophagitis - Grade 3
|
4 participants
|
|
Safety of Chemo-radiotherapy
Radiation Esophagitis - Grade 4
|
0 participants
|
|
Safety of Chemo-radiotherapy
Radiation Pneumonitis - Grade 3
|
1 participants
|
|
Safety of Chemo-radiotherapy
Radiation Pneumonitis - Grade 4
|
0 participants
|
Adverse Events
Gemcitabine + Cisplatin
Serious adverse events
| Measure |
Gemcitabine + Cisplatin
n=49 participants at risk
Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.1%
2/49 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
1/49 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.1%
2/49 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49 • Number of events 2
|
|
General disorders
Hyperthermia
|
2.0%
1/49 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/49 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
8.2%
4/49 • Number of events 4
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
4.1%
2/49 • Number of events 2
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.0%
1/49 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
2.0%
1/49 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
4.1%
2/49 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/49 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine + Cisplatin
n=49 participants at risk
Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
65.3%
32/49 • Number of events 44
|
|
Blood and lymphatic system disorders
Leukopenia
|
44.9%
22/49 • Number of events 52
|
|
Blood and lymphatic system disorders
Lymphopenia
|
44.9%
22/49 • Number of events 34
|
|
Blood and lymphatic system disorders
Neutropenia
|
59.2%
29/49 • Number of events 55
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.9%
22/49 • Number of events 44
|
|
Ear and labyrinth disorders
Tinnitus
|
6.1%
3/49 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
4/49 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
38.8%
19/49 • Number of events 22
|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
8/49 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
4/49 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
20.4%
10/49 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
69.4%
34/49 • Number of events 60
|
|
Gastrointestinal disorders
Oesophagitis
|
8.2%
4/49 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
28/49 • Number of events 40
|
|
General disorders
Asthenia
|
14.3%
7/49 • Number of events 7
|
|
General disorders
Chest pain
|
6.1%
3/49 • Number of events 3
|
|
General disorders
Fatigue
|
42.9%
21/49 • Number of events 26
|
|
General disorders
Pyrexia
|
10.2%
5/49 • Number of events 6
|
|
Infections and infestations
Rhinitis
|
10.2%
5/49 • Number of events 5
|
|
Investigations
Weight decreased
|
22.4%
11/49 • Number of events 11
|
|
Metabolism and nutrition disorders
Anorexia
|
32.7%
16/49 • Number of events 19
|
|
Nervous system disorders
Headache
|
10.2%
5/49 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
6.1%
3/49 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
9/49 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.3%
8/49 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.1%
3/49 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.1%
3/49 • Number of events 3
|
|
Vascular disorders
Hypertension
|
10.2%
5/49 • Number of events 6
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60