Trial Outcomes & Findings for Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLC (NCT NCT00226590)
NCT ID: NCT00226590
Last Updated: 2017-03-23
Results Overview
Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
COMPLETED
PHASE2
39 participants
Ranging from 2 weeks up to 4 years, 9 months
2017-03-23
Participant Flow
Participant milestones
| Measure |
Combination Therapy
In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLC
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=39 Participants
In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Ranging from 2 weeks up to 4 years, 9 monthsPopulation: Per Protocol
Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Outcome measures
| Measure |
Induction Therapy
n=39 Participants
Tolerance of Induction Therapy prior to Chemoradiation
|
|---|---|
|
Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation
|
38 participants
|
SECONDARY outcome
Timeframe: Ranging from 2 weeks up to 4 years, 9 monthsPopulation: per protocol
To determine median Progression Free Survival rate. Progression-free survival (PFS) is defined as the interval between the date of the first chemotherapy administration and the date of objective progression or death. Progression was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Outcome measures
| Measure |
Induction Therapy
n=38 Participants
Tolerance of Induction Therapy prior to Chemoradiation
|
|---|---|
|
Progression Free Survival
|
22.7 months
Interval 2.9 to 69.9
|
SECONDARY outcome
Timeframe: Ranging from 2 weeks up to 4 years, 9 monthsTo determine median Overall Survival rate
Outcome measures
| Measure |
Induction Therapy
n=38 Participants
Tolerance of Induction Therapy prior to Chemoradiation
|
|---|---|
|
Overall Survival
|
14.3 months
Interval 4.1 to 74.4
|
SECONDARY outcome
Timeframe: Ranging from 2 weeks up to 4 years, 9 monthsPopulation: per protocol
The number of participants who completed all treatment on schedule without dose reductions or delays.
Outcome measures
| Measure |
Induction Therapy
n=38 Participants
Tolerance of Induction Therapy prior to Chemoradiation
|
|---|---|
|
Treatment Completion
|
19 participants
|
Adverse Events
Combination Therapy
Serious adverse events
| Measure |
Combination Therapy
n=39 participants at risk
In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
|
|---|---|
|
Gastrointestinal disorders
Esophageal stricture requiring dilatation
|
2.6%
1/39 • Number of events 1 • Ranging from 2 weeks up to 4 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.8%
5/39 • Number of events 5 • Ranging from 2 weeks up to 4 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumo
|
5.1%
2/39 • Number of events 2 • Ranging from 2 weeks up to 4 years, 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Gerald Bepler, M.D., Ph.D., c/o Moffitt Cancer Center
Karmanos Cancer Institute (formerly at Moffitt Cancer Center)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place