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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03132532
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Schild, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Device: Proton Beam Therapy Drug: Carboplatin Drug: Paclitaxel Phase 2

Detailed Description:

This research is being done to study which dose of proton radiotherapy is best for patients diagnosed with stage 2/3 diagnosed with Non-Small Cell Lung Cancer (NSCLC). Patients will be randomized in equal proportions (1:1) to a single dose level (60 vs 72 Gy) balanced based on the stratification factors. The duration of radiation therapy and chemotherapy will be about 6-7½ weeks. Patient will receive concurrent chemotherapy, Carboplatin and Paclitaxel (weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidation). Duration of trial participation is about 5 years. The investigator will permit study-related monitoring, audits, and inspections by the IRB, and government regulatory agencies, of all study related documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.). The investigator will ensure the capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.).

Participation as an investigator in this study implies acceptance of potential inspection by government regulatory authorities and applicable compliance offices. 42 total (n=21 per arm) evaluable patients will need to be accrued onto this randomized phase II study unless undue adverse events are encountered. Anticipated accruing an additional 6 patients (3 per dose level) to account for ineligibility, cancellation, major treatment violation, or other reasons. Maximum projected accrual is therefore 48 patients total.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Chemotherapy and Proton Beam Therapy 60 gray (Gy)
Concurrent and consolidative chemotherapy carboplatin/paclitaxel & Proton Beam Therapy to 60 Gy in 2 Gy daily fractions
Device: Proton Beam Therapy
Proton Beam Therapy (radiation) at either 60 Gy, 66 Gy, or 72 Gy.

Drug: Carboplatin
IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Carboplatin, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
Other Name: Paraplatin

Drug: Paclitaxel
IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Paclitaxel, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
Other Name: Taxol

Active Comparator: Chemotherapy and Proton Beam Therapy 66 Gy
Concurrent and consolidative chemotherapy carboplatin/paclitaxel & Proton Beam Therapy to 66 Gy in 2 Gy daily fractions
Device: Proton Beam Therapy
Proton Beam Therapy (radiation) at either 60 Gy, 66 Gy, or 72 Gy.

Drug: Carboplatin
IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Carboplatin, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
Other Name: Paraplatin

Drug: Paclitaxel
IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Paclitaxel, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
Other Name: Taxol

Active Comparator: Chemotherapy and Proton Beam Therapy 72 Gy
Concurrent and consolidative chemotherapy carboplatin/paclitaxel & Proton Beam Therapy to 72 Gy in 2 Gy daily fractions
Device: Proton Beam Therapy
Proton Beam Therapy (radiation) at either 60 Gy, 66 Gy, or 72 Gy.

Drug: Carboplatin
IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Carboplatin, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
Other Name: Paraplatin

Drug: Paclitaxel
IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Paclitaxel, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
Other Name: Taxol




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Initial estimated completion date for the Primary Endpoint of this study is 36 months after the study opens to accrual.Primary Endpoint Completion Date is at the time the last patient registered has been followed for at least 12months. ]
    PFS time is defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. If a patient dies without a documentation of disease progression the patient will be censored on the last date the disease was evaluated. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-randomization. All patients meeting the eligibility criteria who have signed a consent form, have begun treatment, and have not been declared a major treatment violation will be evaluable.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132532


Contacts
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Contact: Clinical Trials Referral Office 855-776-0015 Maleyeva.Diana@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Diana Maleyeva    480-342-6885    Maleyeva.Diana@mayo.edu   
Principal Investigator: Steven E Schild, MD         
United States, Minnesota
Mayo Clinic in Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Adam Amundson    507-266-8619    Amundson.Adam@mayo.edu   
Principal Investigator: Yolanda Garces, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Steven E Schild Mayo Clinic
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Responsible Party: Steven Schild, Professor of Radiation Oncology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03132532    
Other Study ID Numbers: 16-008343
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action