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

NCT01076231 | Completed Phase 1 Results DMC

• 2 other identifiers: UPCC 25508NCI-2010-00251
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage IIIA Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants Deemed Feasible to Receive Intervention

  Feasibility will be based on multiple radiation planning and treatment parameters. Study will be deemed feasible if all patients are deemed feasible.

  90 Days

• Dose-limiting Toxicity

  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.

  90 Days

• Late Toxicity

  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.

  4.5 Years

Secondary Outcomes (1)

• Pathologic CR Rate

  90 days

Study Arms (1)

Arm I

EXPERIMENTAL

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.

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

Interventions

proton beam radiation therapy RADIATION

Arm I

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP, Neoplatin, PDD

Arm I

etoposide DRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, epipodophyllotoxin, VePesid, VP-16, VP-16-213

Arm I

therapeutic conventional surgery PROCEDURE

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Simone CB 2nd, Yegya-Raman N, Manjunath S, Verma V, Shabason JE, Xu L, Cengel KA, Levin WP, Berman AT, Christodouleas JP, Aggarwal C, Cohen RB, Langer CJ, Pechet TT, Singhal S, Kucharczuk JC, Rengan R, Feigenberg SJ. Prospective Feasibility and Phase 1/2 Trial of Preoperative Proton Beam Therapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):683-689. doi: 10.1016/j.ijrobp.2023.05.016. Epub 2023 May 17. No abstract available.

  PMID: 37201756 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Proton Therapy; Cisplatin; Etoposide; Podophyllotoxin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Lignans; Benzyl Compounds; Benzene Derivatives

Results Point of Contact

• Title: Dr. Jacob Shabason
• Organization: University of Pennsylvania

susan.mazzoni@uphs.upenn.edu

215-662-3998

Study Officials

• Jacob Shabason, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 26, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: May 24, 2018
• Last Updated: May 17, 2021
• Results First Posted: May 17, 2021

Record last verified: 2021-04

Locations

US (1)