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Carcinoma, Non-Small-Cell LungPhase 1NCT02172846

Hypofractionated Proton Beam Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Stage II-III Non-Small Cell Lung Cancer

A Phase 1 study testing Proton beam radiation therapy (PBT), Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of hypofractionated proton beam radiation therapy when given together with paclitaxel and carboplatin in treating patients with stage II-III non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Proton beam radiation therapy (PBT), Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
22 May 2014to 2 Oct 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically proven diagnosis of non-small cell lung cancer.
  • Clinical AJCC stage II-III (AJCC, 7th ed.) with plans to be treated with concurrent chemoradiotherapy.
  • Recurrent non-small cell lung cancer is allowed, provided the intent of the current treatment is curative and there has been no prior radiation to the thorax.
  • Prior chemotherapy, immunotherapy, or targeted therapy is permitted as long as patients have recovered from prior toxicities to grade ≤ 1
  • Appropriate stage for protocol entry based upon the following minimum diagnostic workup:
  • History/physical examination within 30 days prior to registration;
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  • FDG-PET/CT scan for staging within 60 days prior to registration;
  • MRI scan with contrast of the brain (preferred) or CT scan of the brain with contrast within 60 days prior to registration.
  • Zubrod Performance Status 0-2 within 30 days prior to registration.
  • Age ≥ 18 years.
  • CBC/differential obtained within 30 days prior to registration, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
  • Platelets ≥ 100,000 cells/mm3;
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
  • AST and ALT ≤ 1.5 upper limit of normal within 30 days prior to registration.
  • Total bilirubin ≤ 1.5 upper limit of normal within 30 days prior to registration.
  • Serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula:
  • Creatinine Clearance (male) = [(140 - age) x (wt in kg)] [(Serum Creatinine mg/dl) x (72)]
  • Creatinine Clearance (female) = 0.85 x Creatinine Clearance (male)
  • Peripheral neuropathy ≤ grade 1 at the time of registration.
  • Presence of measurable or evaluable disease.
  • Negative serum or urine pregnancy test within 2 weeks prior to registration for women of childbearing potential.
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.
  • Able to understand and willing to sign an IRB-approved informed consent document.
  • Both men and women and members of all races and ethnic groups are eligible for this trial.

Who cannot join

  • Severe, active comorbidity, defined as follows:
  • Unstable angina, history of myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol;
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
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  • Prior radiotherapy to the thorax.
  • Currently receiving any other investigational agents.
  • Pregnant or breastfeeding.
  • Presence of a cardiac pacemaker (due to the risk created by the proton magnet).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I Study of Radiation Dose Intensification With Accelerated Hypofractionated Proton Therapy and Chemotherapy for Non-small Cell Lung Cancer

This phase I trial studies the side effects and best dose of hypofractionated proton beam radiation therapy when given together with paclitaxel and carboplatin in treating patients with stage II-III non-small cell lung cancer. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Giving proton beam radiation therapy at higher doses over fewer days (hypofractionation) may improve local control of the tumor. Giving hypofractionated proton beam radiation therapy with chemotherapy may be a better treatment for non-small cell lung cancer

Being tested
Proton beam radiation therapy (PBT), Paclitaxel, Carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton beam radiation therapy (PBT)Radiation

  • PaclitaxelDrug

    Also called Abraxane®, Onxol®, Taxol®

  • CarboplatinDrug

    Also called Paraplatin®, CBDCA

Study groups in NCT02172846
Study groupRoleWhat they receive
Treatment (PBT, paclitaxel, and carboplatin)ExperimentalCHEMORADIATION THERAPY: * PBT daily 5 days a week over 3 weeks for a total of 15 fractions * Paclitaxel intravenously (IV) over 1 hour weekly for 3 weeks * Carboplatin intravenously (IV) over 30 minutes weekly for 3 weeks. CONSOLIDATION CHEMOTHERAPY (B=beginning 4-6 weeks after completion of radiation therapy, patients may receive): * Paclitaxel IV over 1 hour on day 1 * Carboplatin IV over 30 minutes on day 1 * At the discretion of the treating physician * Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: Proton beam radiation therapy (PBT); Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of hypofractionated proton beam therapy (PBT) with chemotherapy

    Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used. The MTD will be chosen as the dose that yields a posterior estimate of toxicity closest to 20% while being between 15% and 25%.

    Dose limiting toxicity will be defined as toxicity that occurs within 6 months from the start of treatment, is possibly, probably or definitely related to treatment, and is related to the following

    Grade 3-5 pericardial effusion, pericarditis, restrictive cardiomyopathy, hemorrhage (pulmonary or upper respiratory), excluding nose, larynx, or pharynx, brachial plexopathy, laryngeal nerve dysfunction, myelitis, phrenic nerve dysfunction , atelectasis (grade 4-5 only), pulmonary fistula, hypoxia (provided grade 3 is worse than baseline), obstruction/stenosis of the airway, pleural effusion, pneumonitis, pulmonary fibrosis Grade 4-5 dysphagia, esophagitis, esophageal fistula, obstruction, perforation, stricture/stenosis, ulcer, and hemorrhage Grade 4-5 skin Any grade 5

    Measured: Up to 6 months

Secondary outcomes (2)

  1. Incidence of acute toxicities

    Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used.

    Adverse events will be tabulated by type and grade.

    Measured: Up to 6 months

  2. Incidence of late toxicities as defined

    Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used.

    Adverse events will be tabulated by type and grade.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2014 (estimated)
  2. Study start22 May 2014
  3. Primary completion23 Aug 2016
  4. Study completion2 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02172846
Sponsor's protocol ID
201404047
Status last verified
Dec 2017
First submitted
20 Jun 2014
Last updated
8 Dec 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Proton beam radiation therapy (PBT), Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of hypofractionated proton beam therapy (PBT) with chemotherapy (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02172846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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