Trial Outcomes & Findings for Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer (NCT NCT00776100)
NCT ID: NCT00776100
Last Updated: 2017-03-06
Results Overview
Overall survival was defined as the time from registration to the date of death or last follow-up
TERMINATED
PHASE2
3 participants
Time from registration to death or last follow-up (up to 5 years)
2017-03-06
Participant Flow
Four participants were pre-registered between May 2009 and March 2010. One participant was deemed a screen failure due to eligibility reasons and 3 participants have been randomized between October 2009 and March 2010. The study was terminated prematurely on July 16, 2010 due to slow enrollment.
One of the randomized participants was deemed a cancel after going off study prior to receiving study treatment, thus, excluded from all analyses.
Participant milestones
| Measure |
Arm I (No Radiation)
Patients undergo observation for 6 weeks.
|
Arm II (Radiation Therapy)
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm I (No Radiation)
Patients undergo observation for 6 weeks.
|
Arm II (Radiation Therapy)
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
Baseline Characteristics
Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (No Radiation)
n=1 Participants
Patients undergo observation for 6 weeks.
|
Arm II (Radiation Therapy)
n=1 Participants
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Gender
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Gender
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time from registration to death or last follow-up (up to 5 years)Population: Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.
Overall survival was defined as the time from registration to the date of death or last follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.
A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to disease progression or death (up to 5 years)Population: Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.
Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to disease progression (up to 5 years)Population: Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.
Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.
Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.
Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (No Radiation)
Arm II (Radiation Therapy)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (No Radiation)
n=1 participants at risk
Patients undergo observation for 6 weeks.
|
Arm II (Radiation Therapy)
n=1 participants at risk
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/1 • 6 months
All participants who met the eligibility criteria and started the study.
|
100.0%
1/1 • Number of events 2 • 6 months
All participants who met the eligibility criteria and started the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
100.0%
1/1 • Number of events 1 • 6 months
All participants who met the eligibility criteria and started the study.
|
0.00%
0/1 • 6 months
All participants who met the eligibility criteria and started the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60