CompletedPhase 1 / Phase 2NCT01076231

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

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.

Checked against the public recordLast updated May 17, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations1
SponsorAbramson Cancer Center at Penn Medicine
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Abramson Cancer Center at Penn Medicine
Interventions being studied
Radiation: proton beam radiation therapy; Drug: cisplatin; Drug: etoposide; Procedure: therapeutic conventional surgery
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Abramson Cancer Center of The University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 17, 2021. Always confirm current availability with the study team.

View original record ↗