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Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery

Information source: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage IIIA Non-small Cell Lung Cancer

Intervention: proton beam radiation therapy (Radiation); cisplatin (Drug); etoposide (Drug); therapeutic conventional surgery (Procedure)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Abramson Cancer Center of the University of Pennsylvania

Official(s) and/or principal investigator(s):
Charles Simone, MD, Principal Investigator, Affiliation: Abramson Cancer Center of the University of Pennsylvania

Overall contact:
Charles Simone, MD, Phone: 855-216-0098, Email: PennCancerTrials@emergingmed.com


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.

Clinical Details

Official title: Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:


Dose-limiting toxicity

Pathologic CR rate

Late toxicity

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- 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


- 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

Locations and Contacts

Charles Simone, MD, Phone: 855-216-0098, Email: PennCancerTrials@emergingmed.com

Abramson Cancer Center of The University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Charles Simone, MD, Phone: 855-216-0098, Email: PennCancerTrials@emergingmed.com
Charles Simone, MD, Principal Investigator
Additional Information

Starting date: January 2010
Last updated: November 12, 2014

Page last updated: August 23, 2015

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