Phase 2
N=34
Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Stage IIIA Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01076231 ↗Enrolled (actual)
34
Serious AEs
20.6%
Results posted
May 2021
Primary outcome: Primary: Number of Participants Deemed Feasible to Receive Intervention — 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- proton beam radiation therapy (Radiation); cisplatin (Drug); etoposide (Drug); therapeutic conventional surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Deemed Feasible to Receive Intervention |
21 | — |
| PRIMARY Dose-limiting Toxicity |
— | — |
| PRIMARY Late Toxicity |
— | — |
| SECONDARY Pathologic CR Rate |
21 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01076231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.