Locally Advanced Non-Small Cell Lung Cancer
Conditions
Keywords
Proton, Radiation
Brief summary
The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.
Interventions
RADIATIONProton Radiation Therapy
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. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
DRUGTaxol
200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
DRUGCarboplatin
AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical stage 2, 3A or 3B (unresectable) * Histologic evidence of non-small cell carcinoma * Age \> 18 years * Karnofsky performance status 70 or greater * No prior radiation to the chest * No previous chemotherapy
Exclusion criteria
* Clinical stage 1 or 4 * Previous malignancies except for non-melanoma skin cancer unless disease free for \> 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival. | Monthly for duration of participant lifespan. Average lifespan 1-2 years | Median survival time following treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Related Toxicities. | 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 |
Countries
United States
Participant flow
Recruitment details
Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 28 |
| serious Total, serious adverse events | 4 / 28 |
Outcome results
Primary
Overall Survival.
Median survival time following treatment.
Time frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemothrapy and Proton Therapy | Overall Survival. | 15 Months |
Secondary
Treatment Related Toxicities.
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
Time frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemothrapy and Proton Therapy | Treatment Related Toxicities. | 2 participants |