Trial Outcomes & Findings for Study of Vinorelbine and Cisplatin as Induction Therapy With Radiotherapy in Patients With Unresectable NSCLC (NCT NCT02709720)
NCT ID: NCT02709720
Last Updated: 2024-01-11
Results Overview
To evaluate the efficacy in terms of progression-free survival (PFS) of oral metronomical vinorelbine and cisplatin as an induction treatment and then with concomitant radiotherapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions The PFS is defined as the time from the moment of patient inclusion to the documentation of progression or death from any cause (patients who die without evidence of progression, will be considered events on the date of death).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
From patient inclusion up to the date of first documented progression or date of death from any cause, whichever came first, up to 24 months.
Results posted on
2024-01-11
Participant Flow
Participant milestones
| Measure |
Experimental Group
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Experimental Group
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Overall Study
Non-compliance with inclusion criteria
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Not take study medication
|
1
|
Baseline Characteristics
Study of Vinorelbine and Cisplatin as Induction Therapy With Radiotherapy in Patients With Unresectable NSCLC
Baseline characteristics by cohort
| Measure |
Experimental Group
n=65 Participants
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
65 Participants
n=5 Participants
|
|
Smoking status
Non smoker
|
3 Participants
n=5 Participants
|
|
Smoking status
Former smoker
|
27 Participants
n=5 Participants
|
|
Smoking status
Smoker
|
35 Participants
n=5 Participants
|
|
Body mass index
|
26.6 kg/m^2
n=5 Participants
|
|
Weight
Under weight
|
2 Participants
n=5 Participants
|
|
Weight
Normal weight
|
21 Participants
n=5 Participants
|
|
Weight
Overweight
|
25 Participants
n=5 Participants
|
|
Weight
Obesity
|
17 Participants
n=5 Participants
|
|
ECOG
ECOG 0
|
34 Participants
n=5 Participants
|
|
ECOG
ECOG 1
|
31 Participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
27 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
29 Participants
n=5 Participants
|
|
Histology
Large cell carcinoma
|
1 Participants
n=5 Participants
|
|
Histology
Adenosquamous carcinoma
|
4 Participants
n=5 Participants
|
|
Histology
Others
|
2 Participants
n=5 Participants
|
|
Histology
Not registered
|
2 Participants
n=5 Participants
|
|
Stage
IIIA
|
27 participants
n=5 Participants
|
|
Stage
IIIB
|
38 participants
n=5 Participants
|
|
Stage T
TX
|
1 Participants
n=5 Participants
|
|
Stage T
T1
|
5 Participants
n=5 Participants
|
|
Stage T
T2
|
10 Participants
n=5 Participants
|
|
Stage T
T3
|
13 Participants
n=5 Participants
|
|
Stage T
T4
|
36 Participants
n=5 Participants
|
|
Stage N
N0
|
5 Participants
n=5 Participants
|
|
Stage N
N1
|
7 Participants
n=5 Participants
|
|
Stage N
N2
|
35 Participants
n=5 Participants
|
|
Stage N
N3
|
18 Participants
n=5 Participants
|
|
Stage M
M0
|
65 Participants
n=5 Participants
|
|
Stage M
M1
|
0 Participants
n=5 Participants
|
|
Electrocardiogram
Not done
|
2 participants
n=5 Participants
|
|
Electrocardiogram
Normal
|
54 participants
n=5 Participants
|
|
Electrocardiogram
Not normal
|
9 participants
n=5 Participants
|
|
Respiratory functional tests
Normal
|
64 participants
n=5 Participants
|
|
Respiratory functional tests
Not normal
|
1 participants
n=5 Participants
|
|
Compliance
Treatment completed
|
51 participants
n=5 Participants
|
|
Compliance
Treatment not completed
|
14 participants
n=5 Participants
|
|
Cycles
Cycle 1 to Cycle 4 completed
|
51 Participants
n=5 Participants
|
|
Cycles
Cycle 1 to Cycle 3 completed
|
2 Participants
n=5 Participants
|
|
Cycles
Cycle1 and Cycle 2 completed and C3 incompleted
|
1 Participants
n=5 Participants
|
|
Cycles
Cycle 1 and Cycle 2 completed
|
6 Participants
n=5 Participants
|
|
Cycles
C1 completed and C2 incompleted
|
1 Participants
n=5 Participants
|
|
Cycles
Cycle 1 completed
|
2 Participants
n=5 Participants
|
|
Cycles
Cycle 1 incompleted
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From patient inclusion up to the date of first documented progression or date of death from any cause, whichever came first, up to 24 months.Population: All study patients will be included and analysed in the intention-to-treat population.
To evaluate the efficacy in terms of progression-free survival (PFS) of oral metronomical vinorelbine and cisplatin as an induction treatment and then with concomitant radiotherapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions The PFS is defined as the time from the moment of patient inclusion to the documentation of progression or death from any cause (patients who die without evidence of progression, will be considered events on the date of death).
Outcome measures
| Measure |
Experimental Group
n=65 Participants
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Progression-free Survival
|
11.5 months
Interval 9.6 to 15.4
|
SECONDARY outcome
Timeframe: From the start of the treatment of the patient to 6 month afther the treatment endThe objective response rate will be calculated from the sum of the number of patients whose best response is complete response, partial response and stable disease divided by the total number of patients eligible for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Experimental Group
n=65 Participants
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Objective Response Rate 6 Month
|
78.1 percentage of participants
Interval 64.6 to 86.9
|
SECONDARY outcome
Timeframe: From the date of randomization until end of follow up or death, up to 24 months.Overall survival will be measured from the date of patient inclusion until death or loss of follow-up. In patients who have not died, the duration of survival will be censored on the date of the last contact if the patient causes loss of follow-up or on the date of the latest news.
Outcome measures
| Measure |
Experimental Group
n=65 Participants
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Overall Survival (Estimated)
|
35.6 Month
Interval 24.4 to 46.8
|
Adverse Events
Experimental Group
Serious events: 10 serious events
Other events: 64 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental Group
n=65 participants at risk
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Vascular disorders
Visceral arterial ischemia
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Vascular disorders
Thromboembolic event
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Infections and infestations
Catheter related infection
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
4.6%
3/65 • Number of events 3 • 25 months
|
|
Renal and urinary disorders
Renal insufficiency
|
6.2%
4/65 • Number of events 4 • 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Esophagitis
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/65 • Number of events 1 • 25 months
|
Other adverse events
| Measure |
Experimental Group
n=65 participants at risk
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Vinorelbine: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 1 and 2 day 1, 80 mg/m2
Vinorelbine: Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
Cisplatin: Cycle 3 and 4 day 1, 80 mg/m2
Radiotherapy: concomitant therapy during cycles 3 and 4. Total dose: 66Gy
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.8%
33/65 • Number of events 33 • 25 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
4/65 • Number of events 4 • 25 months
|
|
Ear and labyrinth disorders
Tinnitus
|
4.6%
3/65 • Number of events 3 • 25 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Constipation
|
15.4%
10/65 • Number of events 10 • 25 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.8%
22/65 • Number of events 22 • 25 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Gastrointestinal disorders
Dysphagia
|
24.6%
16/65 • Number of events 16 • 25 months
|
|
Gastrointestinal disorders
Esophagitis
|
35.4%
23/65 • Number of events 23 • 25 months
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Gastrointestinal disorders
Mucositis oral
|
10.8%
7/65 • Number of events 7 • 25 months
|
|
Gastrointestinal disorders
Vomiting
|
78.5%
51/65 • Number of events 51 • 25 months
|
|
General disorders
Fatigue
|
40.0%
26/65 • Number of events 26 • 25 months
|
|
General disorders
Edema limbs
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
General disorders
Fever
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Blood and lymphatic system disorders
Creatinine increased
|
4.6%
3/65 • Number of events 3 • 25 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
46.2%
30/65 • Number of events 30 • 25 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
18.5%
12/65 • Number of events 12 • 25 months
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Metabolism and nutrition disorders
Anorexia
|
16.9%
11/65 • Number of events 11 • 25 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Metabolism and nutrition disorders
Hipocalcemia
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Metabolism and nutrition disorders
Hipomagnesemia
|
6.2%
4/65 • Number of events 4 • 25 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
3/65 • Number of events 3 • 25 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Nervous system disorders
Dizziness
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Nervous system disorders
Dysgeusia
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Nervous system disorders
Paresthesia
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.6%
3/65 • Number of events 3 • 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.1%
2/65 • Number of events 2 • 25 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.6%
3/65 • Number of events 3 • 25 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/65 • Number of events 1 • 25 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
1.5%
1/65 • Number of events 1 • 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place