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

This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01076231
First received: February 23, 2010
Last updated: February 26, 2013
Last verified: February 2013

February 23, 2010
February 26, 2013
January 2010
July 2014   (final data collection date for primary outcome measure)
  • Feasibility [ Designated as safety issue: No ]
    Feasibility will be based on multiple radiation planning and treatment parameters.
  • Dose-limiting toxicity [ Designated as safety issue: Yes ]
    DLT is defined as post-operative mortality (within 30 days of surgery) or any grade 3 or higher pneumonitis or any other grade 4 or higher toxicity which occurs during chemoradiation or within 90 days following the end of treatment, whichever is longer.
  • Pathologic CR rate [ Designated as safety issue: No ]
    Pathologic CR rate is defined as the fraction of patients who undergo surgery and have no evidence of disease based on surgical pathology.
  • Late toxicity [ Designated as safety issue: Yes ]
    Late toxicity is defined as any grade 3 or higher pneumonitis or any grade 4 or higher toxicity which occurs more than 90 days after surgery or completion of treatment.
Same as current
Complete list of historical versions of study NCT01076231 on ClinicalTrials.gov Archive Site
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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
Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stage IIIA Non-small Cell Lung Cancer
  • Radiation: proton beam radiation therapy
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
    • Neoplatin
    • PDD
  • Drug: etoposide
    Given IV
    Other Names:
    • Demethyl Epipodophyllotoxin Ethylidine Glucoside
    • EPEG
    • epipodophyllotoxin
    • VePesid
    • VP-16
    • VP-16-213
  • Procedure: therapeutic conventional surgery
Experimental: Arm I

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.

Interventions:
  • Radiation: proton beam radiation therapy
  • Drug: cisplatin
  • Drug: etoposide
  • Procedure: therapeutic conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ramesh Rengan, MD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT01076231
UPCC 25508, NCI-2010-00251
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: Ramesh Rengan Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP