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Lung CancerPhase 2NCT03321760

SABR for T1-2a N1 NSCLC

A Phase 2 study testing Stereotactic Ablative Radiation Therapy (SABR) in people with Lung Cancer, run by Indiana University at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Conventionally fractionated radiation therapy given over 6-7 weeks alone, sequentially, or concurrent with chemotherapy have produced poor outcomes in Stage II NSCLC in most series. Stereotactic ablative radiotherapy (SABR) has been shown to be very effective and is now standard of care for Stage 1 disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Stereotactic Ablative Radiation Therapy (SABR)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
1 Jan 2022to 31 Dec 2027
Phase
Phase 2
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

  • Age ≥ 18 years old at time of consent
  • Ability to provide written informed consent and HIPAA authorization
  • Pathological diagnosis of NSCLC lung cancer
  • Staging PET/CT within 45 days of consult
  • EBUS or other histologic confirmation of N1 involvement (diagnosis of lung cancer should come from the hilar [N1] disease)
  • T1/2a <5cm lung primary
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  • N1 disease <5cm
  • Patient refuses surgery or deemed inoperable
  • KPS of > 60
  • Baseline labs including CBC/differential and BMP within 45 days of consult
  • CBC/differential 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.)
  • Adequate renal function defined as serum creatinine within normal institutional limits or creatinine clearance must be at least 20 ml/min
  • Adequate hepatic function defined as total bilirubin ≤ 3.0 x upper limit of normal (ULN) for the institution and ALT, AST, and alkaline phosphatase ≤ 3.0 x ULN for the institution
  • If a pleural effusion is present, the following criteria must be met at registration to exclude malignant involvement (incurable M1a disease):
  • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative;
  • Effusions that are minimal (i.e. not visible under ultrasound guidance) and that are too small to safely tap are eligible.
  • Women of childbearing potential and male participants must practice adequate contraception throughout the study
  • Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration
  • Eligible for adjuvant chemotherapy as determined by the treating medical oncologist

Who cannot join

  • Previous radiation therapy overlapping with current radiation target as determined by the discretion of the investigator
  • Inability to comply with treatment per investigator discretion.
  • Inability to follow standard of care follow up recommendations per investigator discretion.
  • Pregnant and breastfeeding women
  • Contra-indication to platinum-based two drug chemotherapy as determined by the treating medical oncologist
  • Patients with a history of chronic kidney disease or lactic acidosis
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  • Severe, active co-morbidity, defined as follows:
  • Uncontrolled neuropathy ≥ grade 2 regardless of cause ii. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months iii. Transmural myocardial infarction within the last 6 months iv. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration v. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration vi. Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease vii. HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
  • End-stage renal disease (i.e. on dialysis or dialysis has been recommended).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Phase II Evaluation With Safety Run-in of Stereotactic Ablative Body Radiation for T1-2a N1 Non-Small Cell Lung Cancer

Conventionally fractionated radiation therapy given over 6-7 weeks alone, sequentially, or concurrent with chemotherapy have produced poor outcomes in Stage II NSCLC in most series. Stereotactic ablative radiotherapy (SABR) has been shown to be very effective and is now standard of care for Stage 1 disease. There has been initially reluctance to utilize SABR for central lung tumors because of published reports that showed an excess of toxicity when SABR was utilized; however, newer data with less intense treatment regimens suggest safety in treatment of central lung disease. The safety and efficacy of SABR in treating hilar nodes or N1 disease currently is not known fully and will be evaluated in this study.

Read the detailed description
  1. Primary Objectives Safety run-in - To determine the safety of SABR for the treatment of primary lung disease and N1 (hilar) node in stage T1-2a N1 NSCLC Phase II - To determine 2-year local control of SABR for T1-2a N1 NSCLC with sequential chemotherapy
  2. Secondary Objectives Phase II - To determine overall and progression-free survival times, pattern of failures, and rates of ≥ grade 3 adverse events after SABR for T1-2a N1 NSCLC combined with sequential chemotherapy
Conditions
Lung Cancer
Being tested
Stereotactic Ablative Radiation Therapy (SABR)
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Stereotactic Ablative Radiation Therapy (SABR)Radiation

    SABR will be delivered to the primary disease and hilar (N1) node over 5 fractions.Reductions may be made to the hilar (N1) node according to a 3+3 design during the run-in period.

Study groups in NCT03321760
Study groupRoleWhat they receive
Run-In Dose 1Experimental10 Gy dose delivered to the primary tumor \& 10 Gy to the hilar (N1) node over 5 fractions
Receives: Radiation: Stereotactic Ablative Radiation Therapy (SABR)
Run-In Dose -1Experimental10 Gy dose delivered to the primary tumor \& 9 Gy to the hilar (N1) node over 5 fractions
Receives: Radiation: Stereotactic Ablative Radiation Therapy (SABR)
Run-In Dose -2Experimental10 Gy dose delivered to the primary tumor \& 8 Gy to the hilar (N1) node over 5 fractions
Receives: Radiation: Stereotactic Ablative Radiation Therapy (SABR)
Phase 2ExperimentalThe maximum tolerated radiation dose to the hilar (N1) node from the run-in period will be used during Phase 2.
Receives: Radiation: Stereotactic Ablative Radiation Therapy (SABR)

What is being measured

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

  1. Rate of dose-limiting toxicities (DLTs) during the run-in period

    Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

    Measured: 30 days

Secondary outcomes (4)

  1. Local control

    Failure of disease progression within or immediately adjacent to the treatment planning target volume (PTV) of the lung primary and nodal disease. Failures will be classified as local failures if failing within or immediately adjacent to the N1 or primary tumor PTV, unless judged by the investigator team to convincingly be a separate lesion from the treated lesion (i.e. new lesion within PTV but across a fissure)

    Measured: 2 years

  2. Progression free survival

    Length of time during and after the treatment that a patient lives with the disease but it does not get worse

    Measured: 2 years

  3. Overall survival

    Length of time start of treatment that patients are still alive

    Measured: 5 years

  4. Rate of dose-limiting toxicities (DLTs) at one year

    Any event per CTCAE v.4 that occurs within 1 year from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

    Measured: 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 posted26 Oct 2017
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Why it stopped: Decided not to open the study.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a Phase II single-institution trial with a 3 + 3 safety run-in period. SABR will be delivered per protocol, followed by a planned 4 cycles of sequential chemotherapy within 3-8 weeks after the completion of SABR. Four cycles of chemotherapy shall be planned as typically used for adjuvant chemotherapy following surgical resection for T1-2aN1 non-small cell lung carcinoma (NSCLC) unless otherwise indicated by institutional guidelines.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03321760
Sponsor's protocol ID
IUSCC-0626
Other IDs
1707319235
Status last verified
Jan 2022
First submitted
23 Oct 2017
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Ablative Radiation Therapy (SABR) in people with Lung Cancer, run by Indiana University at 3 sites 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 22 inclusion and 9 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: withdrawn, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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 dose-limiting toxicities (DLTs) during the run-in period (time frame: 30 days). 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 NCT03321760.

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 9 Feb 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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