View Clinical Trial (Medical Research Study)
Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Stage IIIA Non-small Cell Lung Cancer |
| Purpose: |
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RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that
delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause
less damage to normal tissue in patients with non-small cell lung cancer. Drugs used in
chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. Giving proton
beam radiation therapy together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of proton beam
radiation therapy when given together with cisplatin and etoposide and to see how well it
works in treating patients with stage III non-small cell lung cancer that can be removed by
surgery.
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| Study Summary: |
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PRIMARY OBJECTIVES:
I. To assess feasibility. (Phase I) II. To determine dose-limiting toxicity and maximum
tolerated dose. (Phase I) III. To determine the pathologic CR rate. (Phase II)
SECONDARY OBJECTIVES:
I. To assess late complications from irradiation using proton beam therapy in place of
conventional photon beam therapy. (Phase II) II. To assess acute side effects from
irradiation using proton beam therapy in place of conventional photon beam therapy. (Phase
II) III. To compare the dose distribution to tumor and surrounding normal structures using
DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and
the photon plan generated for comparison purposes. (Phase II) IV. To determine
progression-free survival (Phase II) and late toxicity.
OUTLINE: This is a phase I, dose-escalation study of proton beam radiation therapy followed
by a phase II study.
Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent
chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5
and days 29-33.Treatment continues in the absence of disease progression or unacceptable
toxicity.
Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical
resection or additional chemoradiotherapy.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
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| Criteria: |
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Inclusion
- Histologically confirmed diagnosis of NSCLC
- Stage IIIA or Potentially resectable superior sulcus tumors
- No evidence of distant metastatic disease as documented by MRI of the brain and
PET/CT
- Patients must have a Karnofsky Performance Status of >= 60
- Patients must be able to provide informed consent
- WBC >= 4000/mm^3
- Platelets >= 100,000 mm^3
- Creatinine =< 1.2 mg/dl (urinary diversion is permitted to improve renal function)
- Patients must have bilirubin =< 1.5 mg/dl
- Women of child-bearing potential as long as she agrees to use a recognized method of
birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.);
hysterectomy or menopause must be clinically documented
- Negative pregnancy test for women of child-bearing age
Exclusion
- Prior or simultaneous malignancies within the past two years (other than cutaneous
squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) [For pts
that will be on definitive treatment study, otherwise delete for umbrella recurrent
protocol]
- Pregnant women, women planning to become pregnant and women that are nursing
- Actively being treated on any other research study
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| NCT ID: |
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NCT01076231 |
| Primary Contact: |
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Principal Investigator
Ramesh Rengan
Abramson Cancer Center of the University of Pennsylvania
Ramesh Rengan, MD
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
Ramesh Rengan
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
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