AzTrials
AzTrials

Non-Small Cell Lung CancerNCT01797471

Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer

A study testing Lattice Extreme Ablative Dose (LEAD) Radiation Therapy in people with Non-Small Cell Lung Cancer and NSCLC, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage III non-small cell… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Non-Small Cell Lung Cancer, NSCLC
What is being tested?
Lattice Extreme Ablative Dose (LEAD) Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Mar 2013to 6 Nov 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Patients must have histologically or cytologically documented stage III non-small cell lung cancer including squamous cell, adenocarcinoma, large cell carcinoma and poorly differentiated non-small cell lung cancer.
  • Patients must have a minimum of 4 cm of measurable disease in any one continuous dimension as seen on diagnostic CT scan.
  • Pulmonary function tests with forced expiratory volume in 1 second (FEV1) ≥1.45 liters/second.
  • Patients must be 21 years of age or older. There is no maximum age restriction.
  • Patients must have a Zubrod performance status of 0 or 1.
  • Patients must have normal organ and marrow function as defined below:
Show all 15Show fewer
  • leukocyte > 3,000/:I
  • absolute neutrophil count >1,500/:I
  • platelets >100,000/:I
  • bilirubin within normal institutional limits
  • Aspartate transaminase (AST/SGOT)/Alanine transaminase (ALT/SGPT) 2.5 X institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Patients must have weight loss ≤ 10% over the past three months.
  • Women of child-bearing potential and men will be asked to use adequate contraception.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients may not have had prior thoracic radiation at any time, or prior chemotherapy for the study cancer at any time.
  • Patients may not be receiving any other investigational agents for the study cancer.
  • Patients may not have evidence of brain metastases on baseline CT scan or MRI.
  • Patients may not have measurable gross disease in the thorax <4 cm in any one continuous dimension.
  • Patients may not have a cytologically positive pleural effusion.
  • Patients may not have a prior invasive malignancy (unless disease-free for at least 3 years).
Show all 12Show fewer
  • Patients may not have had surgical resection of the present cancer.
  • Women who are pregnant or breastfeeding will be excluded.
  • Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients must not have severe lung disease defined by a history of severe chronic obstructive pulmonary disease (COPD) requiring 3 or more hospitalizations over the past year, or history of interstitial pneumonitis.
  • Patients must not have any concurrent active malignancy.
  • Patients must not have evidence of metastatic disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 1 Study for Evaluating the Safety of Lattice Extreme Ablative Dose (LEAD) Radiotherapy Followed by Standard-Dose Chemoradiation for Patients With Bulky Stage III Non-Small Cell Lung Cancer

The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase I clinical trial. The investigators hypothesize that the addition of a one-time single fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity above that expected with standard-dose concurrent chemotherapy and radiation alone.

Read the detailed description

Paarticipants will receive a single fraction of LEAD radiation on day 1, followed one day later by conventionally fractionated concurrent chemoradiation consisting of 60 Gy of radiation delivered to involved sites of disease and a platinum doublet.

The investigational radiation treatment, a single fraction of LEAD radiation, is to be followed by conventionally fractionated radiation delivered concurrently with a standard chemotherapy regimen for stage III non-small cell lung cancer. The following day, patients will begin concurrent chemotherapy and radiation. Chemotherapy will be delivered under the management of the treating medical oncologist. Chemotherapy must be a platinum doublet. Carboplatin and cisplatin are both considered acceptable platinum agents. The use of cisplatin over carboplatin is strongly encouraged, unless the patient has a contraindication to cisplatin. The second agent will be at the discretion of the treating medical oncologist; in the current era, chemotherapy agents are tailored to each patient based on tumor histology, as well as comorbidities that dictate the tolerance of certain chemotherapeutic agents. Chemotherapy will be delivered concurrently throughout radiation therapy, beginning on day 2 of the treatment protocol and on the same day as the start of standard-dose radiation. Weekly regimens or regimens delivered every 3 weeks are acceptable. Additional cycles of consolidation chemotherapy are encouraged and will be given at the discretion of the treating medical oncologist.

Being tested
Lattice Extreme Ablative Dose (LEAD) Radiation Therapy
Keywords
Non-Small Cell Lung Cancer, NSCLC, Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • Lattice Extreme Ablative Dose (LEAD) Radiation TherapyRadiation

    Also called LEAD Radiotherapy, LEAD Radiation Therapy

    A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1

Study groups in NCT01797471
Study groupRoleWhat they receive
LEAD RTExperimental* Lattice Extreme Ablative Dose (LEAD) Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by; * Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy; * Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.
Receives: Radiation: Lattice Extreme Ablative Dose (LEAD) Radiation Therapy

What is being measured

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

  1. Rate of Treatment-related Toxicity in Study Participants

    Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants. Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.

    Measured: Up to 12 months

Secondary outcomes (5)

  1. Rate of Study Participants Achieving Complete or Partial Response Via CT RECIST Response Criteria

    Number of subjects achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria on CT Scan:

    • CR: Complete disappearance of all disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same technique as baseline.
    • PR: Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.

    Measured: Assessed up to 2 years

  2. Rate of Study Participants Achieving Complete or Partial Response Via PET Response Criteria

    Rate of subjects achieving complete response (CR) or partial response (PR) as detected by positron emission tomography (PET) Scan:

    • CR is defined as no residual focal fluorodeoxyglucose (FDG) uptake or decrease in average FDG uptake by more than 80% in all tumor manifestations.
    • PR is defined as standardized uptake value (SUV) decrease by 0 - 80%.

    Measured: Assessed up to 2 years

  3. Rate of Loco-regional Failure in Study Participants

    Rate of loco-regional failure in study participants. Loco-regional failure is defined as any evidence of disease progression within the primary primary tumor or regional lymph nodes, detected by any method.

    Measured: Assessed up to 2 years

  4. Progression-Free Survival (PFS)

    Rate of progression-free survival (PFS). PFS is defined as the length of time from date of treatment initiation until date of documented disease progression or death from any cause, with censoring of patients who are lost to follow-up.

    Measured: Assessed up to 2 years

  5. Overall Survival (OS)

    Rate of overall survival (OS) in study participants. Overall survival is defined as the length of time from the date of treatment initiation until the date of death from any cause.

    Measured: Assessed up to 2 years

Timeline

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

  1. First posted22 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completion31 May 2013
  4. Study completion6 Nov 2013

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01797471
Sponsor's protocol ID
20100446
Status last verified
Nov 2017
First submitted
20 Feb 2013
Last updated
21 Dec 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Lattice Extreme Ablative Dose (LEAD) Radiation Therapy in people with Non-Small Cell Lung Cancer and NSCLC, run by University of Miami 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 15 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Treatment-related Toxicity in Study Participants (time frame: Up to 12 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 NCT01797471.

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 21 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in