Phase II Trial of Standard Chemotherapy (Carboplatin & Paclitaxel) +Various Proton Beam Therapy (PBT) Doses



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/10/2018
Start Date:July 31, 2017
End Date:December 2023
Contact:Clinical Trials Referral Office
Email:Bosworth.Anne@mayo.edu
Phone:855-776-0015

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MC1623:Phase II Trial of Standard Chemotherapy (Carboplatin & Paclitaxel) +Various Proton Beam Therapy (PBT) Doses in Order to Determine the Optimal Dose of PBT for Unresectable Stage 2/3 Non-Small Cell Lung Cancer

This study is being done to study which dose of proton beam therapy (PBT) for unresectable
stage 2/3 Non-Small Cell Lung Cancer.


Inclusion Criteria:

- Histological confirmation of non-small cell lung cancer

- Forced Expiratory volume in 1 second (FEV1)>1.0 L

- Unresectable stage 2-3 Non-small cell lung cancer (based on CT/positron emission
tomography (PET), MRI or CT of brain, and Physical exam).

• Eligible if recurrence after surgery and now has the equivalent stage 2-3 NSCLC OR
had sub totally resected stage 2-3 NSCLC.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

- Negative pregnancy test done ≤7 days prior to registration, for women of childbearing
potential only.

- The following laboratory values in specified ranges:

- White blood cell count (WBC) ≥3.0 x 109/L,

- Absolute neutrophil count (ANC) ≥1.5 x 109/L,

- Hgb ≥9g/dl

- Plts >100 x 109/L

- Serum creatinine<1.5 times upper limit of normal (ULN)

- Serum bilirubin <1.5 times upper limit of normal (ULN)

- Provide informed written consent.

- Willing to return to enrolling institution for follow-up for a minimum of 1 year.

- Ability to undergo potentially curative chemotherapy plus radiotherapy

Exclusion Criteria:

- Any of the following because this study involves an agent that has known genotoxic,
mutagenic and teratogenic effects:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens.

- Weight loss of >10% in the past 6 months

- Distant metastases (M1 disease)

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, lupus, Usual interstitial pneumonitis
(UIP), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

- Receiving any investigational agent, that would be considered as a treatment for the
primary neoplasm.

- Other active malignancy ≤3 years prior to registration. EXCEPTIONS: treated
non-melanotic skin cancer, carcinoma-in-situ of the cervix, treated Stage 1-2, Gleason
7 or less, prostate cancer with a stable or undetectable prostate specific antigen
(PSA) level, treated stage 1 breast cancer which is controlled and for which the
patient received no thoracic radiotherapy (RT).

- History of myocardial infarction ≤6 months, or congestive heart failure requiring use
of ongoing maintenance therapy for life-threatening ventricular arrhythmias.

- Received chemotherapy for lung cancer within 6 months of registration.

- Previous chest radiotherapy.
We found this trial at
2
sites
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Steven E Schild, MD
Phone: 480-342-4628
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Yolanda Garces, MD
Phone: 507-266-8619
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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