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Low participant enrollment rates. Significant comparative data not obtained.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton therapy with chemotherapy | Experimental | Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks. Proton therapy - 76 Gy in 5 weeks to lung tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation Therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival. | Median survival time following treatment. | Monthly for duration of participant lifespan. Average lifespan 1-2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Monthly for duration of participant lifespan. Average lifespan 1-2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A. Bush, MD | Loma Linda University Department of Radiation Medicine | Principal Investigator |
| Jerry D. Slater, MD | Loma Linda University Department of Radiation Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
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Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
28 subjects were enrolled and received the study treatment. All 28 were followed for treatment outcomes.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival. | Median survival time following treatment. | Posted | Median | 95% Confidence Interval | Months | Monthly for duration of participant lifespan. Average lifespan 1-2 years |
|
|
Participants were followed for the duration of their lifespan, an average of 1-2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Grade 3 pneumonitis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Grade 1/2 esophagitis |
Slow enrollment over a long time period limits the conclusions that can be drawn.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bush MD | Professor of Radiation Medicine, Loma Linda University Medical Center | 909-558-4280 | dbush@llu.edu |
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| ID | Term |
|---|---|
| D011522 | Protons |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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|
| Taxol | Drug | 200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy. |
|
|
| Carboplatin | Drug | AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Number | participants | Monthly for duration of participant lifespan. Average lifespan 1-2 years |
|
|
|
| 4 |
| 28 |
| 12 |
| 28 |
|
| Pulmonary hemorrage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Esophageal Fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |