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This phase I trial studies the side effects and best dose of hypofractionated proton beam radiation therapy when given together with paclitaxel and carboplatin in treating patients with stage II-III non-small cell lung cancer. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Giving proton beam radiation therapy at higher doses over fewer days (hypofractionation) may improve local control of the tumor. Giving hypofractionated proton beam radiation therapy with chemotherapy may be a better treatment for non-small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (PBT, paclitaxel, and carboplatin) | Experimental | CHEMORADIATION THERAPY:
CONSOLIDATION CHEMOTHERAPY (B=beginning 4-6 weeks after completion of radiation therapy, patients may receive):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton beam radiation therapy (PBT) | Radiation |
| ||
| Paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) of hypofractionated proton beam therapy (PBT) with chemotherapy | Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used. The MTD will be chosen as the dose that yields a posterior estimate of toxicity closest to 20% while being between 15% and 25%. Dose limiting toxicity will be defined as toxicity that occurs within 6 months from the start of treatment, is possibly, probably or definitely related to treatment, and is related to the following Grade 3-5 pericardial effusion, pericarditis, restrictive cardiomyopathy, hemorrhage (pulmonary or upper respiratory), excluding nose, larynx, or pharynx, brachial plexopathy, laryngeal nerve dysfunction, myelitis, phrenic nerve dysfunction , atelectasis (grade 4-5 only), pulmonary fistula, hypoxia (provided grade 3 is worse than baseline), obstruction/stenosis of the airway, pleural effusion, pneumonitis, pulmonary fibrosis Grade 4-5 dysphagia, esophagitis, esophageal fistula, obstruction, perforation, stricture/stenosis, ulcer, and hemorrhage Grade 4-5 skin Any grade 5 | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute toxicities | Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used. Adverse events will be tabulated by type and grade. | Up to 6 months |
| Incidence of late toxicities as defined |
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Inclusion Criteria:
Histologically or cytologically proven diagnosis of non-small cell lung cancer.
Clinical AJCC stage II-III (AJCC, 7th ed.) with plans to be treated with concurrent chemoradiotherapy.
Appropriate stage for protocol entry based upon the following minimum diagnostic workup:
Zubrod Performance Status 0-2 within 30 days prior to registration.
Age ≥ 18 years.
CBC/differential obtained within 30 days prior to registration, with adequate bone marrow function defined as follows:
AST and ALT ≤ 1.5 upper limit of normal within 30 days prior to registration.
Total bilirubin ≤ 1.5 upper limit of normal within 30 days prior to registration.
Serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula:
Creatinine Clearance (male) = [(140 - age) x (wt in kg)] [(Serum Creatinine mg/dl) x (72)]
Creatinine Clearance (female) = 0.85 x Creatinine Clearance (male)
Peripheral neuropathy ≤ grade 1 at the time of registration.
Presence of measurable or evaluable disease.
Negative serum or urine pregnancy test within 2 weeks prior to registration for women of childbearing potential.
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.
Able to understand and willing to sign an IRB-approved informed consent document.
Exclusion Criteria:
Severe, active comorbidity, defined as follows:
Prior radiotherapy to the thorax.
Currently receiving any other investigational agents.
Pregnant or breastfeeding.
Presence of a cardiac pacemaker (due to the risk created by the proton magnet).
Inclusion of Women and Minorities
Both men and women and members of all races and ethnic groups are eligible for this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Cliff Robinson, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Drug |
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| Carboplatin | Drug |
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Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used.
Adverse events will be tabulated by type and grade.
| Up to 1 year |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
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