A Phase 1/2 interventional study of Proton Radiation Therapy and Taxol in Locally Advanced Non-Small Cell Lung Cancer, sponsored by Loma Linda University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-22.
Sponsored by Loma Linda University · Phase 1/2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Radiation: Proton Radiation Therapy · Drug: Taxol · Drug: Carboplatin
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.
200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
Also known as: Paclitaxel
AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.
Overall Survival.
Median survival time following treatment.
Time frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years
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
Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.
| Milestone | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
Median survival time following treatment.
| Months | Chemothrapy and Proton Therapy |
|---|---|
| Overall Survival. | 15 (10 to 20) |
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
| participants | Chemotherapy and Proton Therapy |
|---|---|
| Treatment Related Toxicities. | 2 |
Collected over Participants were followed for the duration of their lifespan, an average of 1-2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Chemotherapy and Proton Beam Radiotherapy. | — | 4/28 (14.3%) | 12/28 (42.9%) |
| Event | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/28 |
| Pulmonary hemorrageRespiratory, thoracic and mediastinal disorders | 1/28 |
| Esophageal FistulaRespiratory, thoracic and mediastinal disorders | 1/28 |
| Event | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| EsophagitisRespiratory, thoracic and mediastinal disorders | 12/28 |
28 subjects were enrolled and received the study treatment. All 28 were followed for treatment outcomes.
| Age, Categorical(Participants) | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 15 |
| Age, Continuous(years) | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| Mean | 66 ± 8 |
| Sex: Female, Male(Participants) | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| Female | 11 |
| Male | 17 |
| Region of Enrollment(participants) | Treatment With Chemotherapy and Proton Beam Radiotherapy. |
|---|---|
| United States | 28 |
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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