Trial Outcomes & Findings for Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer (NCT NCT00614484)

NCT ID: NCT00614484

Last Updated: 2014-05-22

Results Overview

Median survival time following treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: Monthly for duration of participant lifespan. Average lifespan 1-2 years
• Results posted on: 2014-05-22

Participant Flow

Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.

Participant milestones

Measure	Treatment With Chemotherapy and Proton Beam Radiotherapy. Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer

Baseline characteristics by cohort

Measure	Treatment With Chemotherapy and Proton Beam Radiotherapy. n=28 Participants Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Monthly for duration of participant lifespan. Average lifespan 1-2 years

Median survival time following treatment.

Outcome measures

Measure	Chemothrapy and Proton Therapy n=28 Participants Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Overall Survival.	15 Months Interval 10.0 to 20.0

SECONDARY outcome

Timeframe: Monthly for duration of participant lifespan. Average lifespan 1-2 years

grade 3 or higher esophageal toxicity

Toxicity is categorized either early or late phase.

Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter

Outcome measures

Measure	Chemothrapy and Proton Therapy n=28 Participants Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Treatment Related Toxicities.	2 participants

Adverse Events

Treatment With Chemotherapy and Proton Beam Radiotherapy.

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment With Chemotherapy and Proton Beam Radiotherapy. n=28 participants at risk Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 2/28 • Number of events 2 • Participants were followed for the duration of their lifespan, an average of 1-2 years
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrage	3.6% 1/28 • Number of events 1 • Participants were followed for the duration of their lifespan, an average of 1-2 years
Respiratory, thoracic and mediastinal disorders Esophageal Fistula	3.6% 1/28 • Number of events 1 • Participants were followed for the duration of their lifespan, an average of 1-2 years

Other adverse events

Measure	Treatment With Chemotherapy and Proton Beam Radiotherapy. n=28 participants at risk Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Respiratory, thoracic and mediastinal disorders Esophagitis	42.9% 12/28 • Number of events 12 • Participants were followed for the duration of their lifespan, an average of 1-2 years

Additional Information

David Bush MD

Professor of Radiation Medicine, Loma Linda University Medical Center

Phone: 909-558-4280

Email: dbush@llu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place