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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage IIIA Non-small Cell Lung Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility

Outcome Description:

Feasibility will be based on multiple radiation planning and treatment parameters.

Safety Issue:

No

Principal Investigator

Ramesh Rengan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 25508

NCT ID:

NCT01076231

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Stage IIIA Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283