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Non-Small Cell Lung Cancer (NSCLC)Phase 1NCT00818714

Stereotactic Body Radiation Therapy (SBRT) as a Boost After Definitive Concurrent Chemoradiation (ChemoRT) for Non-Small Cell Lung Cancer (NSCLC) GCC 0516

A Phase 1 study testing SBRT in people with Non-Small Cell Lung Cancer (NSCLC), run by University of Maryland, Baltimore.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

SBRT to deliver a boost dose to residual primary tumor after definitive doses of standard EBRT have been delivered concurrently with chemotherapy. Serum levels of TGF-Beta1 and correlation with SBRT toxicity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer (NSCLC)
What is being tested?
SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2009to Oct 2009
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

  • Histological confirmation of non-small cell lung cancer will be required by either biopsy or cytology. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.
  • Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage III based on only one of the following combinations of TNM staging:
  • T1N2-3M0
  • T2N2-3M0
  • T3N1-3M0
  • Patients with T4 tumors (by any definition) are not eligible
Show all 27Show fewer
  • Patients must have completed treatment with concurrent chemotherapy and external beam radiation therapy to radiation doses >59.4Gy but <70.2Gy to the primary tumor and doses >45Gy but <70.2Gy to mediastinal structures within 6 to 9 weeks of the first SBRT "Boost" treatment.
  • Patients must have had repeat staging performed after their chemoradiation and within 28 days of their first protocol treatment including: CT scan of chest and upper abdomen, FDG-18 PET scan and MRI of the brain. These studies must demonstrate no disease outside of the thorax.
  • The primary tumor must be deemed technically resectable after chemoradiation by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, PCR). However, the patient must not be a candidate for PCR based on pathologic evidence of persistent mediastinal lymphadenopathy after chemoradiation or because of underlying physiological medical problems that would prohibit a PCR due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functioning lung. These types of patients with severe underlying health problems are deemed "medically inoperable." Standard justification for deeming a patient medically inoperable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline FEV1 < 40% predicted, post-operative predicted FEV1 < 30% predicted, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia, exercise oxygen consumption < 50% predicted, severe pulmonary hypertension, diabetes mellitus with severe end organ damage, severe cerebral, cardiac, or peripheral vascular disease, or severe chronic heart disease.
  • Patients must be ≥ 18 years of age.
  • The patient's Zubrod performance status must be Zubrod 0-2.
  • Women of childbearing potential and male participants must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
  • Pretreatment Evaluations Required for Eligibility include:
  • A medical history, physical examination, weight, assessment of Zubrod performance status within 2 weeks prior to study entry.
  • Evaluation by a thoracic surgeon or pulmonologist within 4 weeks prior to study entry;
  • For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to the start of protocol treatment;
  • PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood gases within 4 weeks prior to study entry.
  • Mandatory staging studies: Must be done within 21 days prior to study entry
  • CT scan (preferably with intravenous contrast) to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; Primary tumor dimension will be measured on CT.
  • Whole body positron emission tomography (PET) scan using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions.
  • MRI of the brain
  • Patients must sign a study-specific consent form.
  • Patients must not have any serious medical or psychiatric illnesses that would prevent compliance or ability to give informed consent.
  • Labs to be within 14 days of start of SBRT:
  • CBC with differential, platelet count, Comprehensive metabolic panel including: electrolytes, Albumin, TBilirubin, Calcium, Cl, CO2, Creatinine, Glucose, K, TProtein, Na, BUN, AlkPhos, AST, ALT, Magnesium.
  • Pre-treatment laboratory values must be as follows:
  • WBC count: < or = 2.5 x institutional ULN; Absolute granulocyte count: > or = 1,500/mm3 Platelets: > or = 100,000/mm3 Total bilirubin: < or = 1.5 x institutional ULN Serum creatinine: < or = 1.5x institutional ULN AST and ALT: < or = 2.5 x institutional ULN Serum albumin: > or = 3.0 g/dL

Who cannot join

  • 1 Patients with primary tumors > 5 cm or involving the central chest and structures of the mediastinum after their definitive course of chemoradiation.
  • 2. The primary tumor of any T-stage within or touching the zone of the proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi.
  • Patients with radiographic pneumonitis obscuring clear delineation of the primary tumor or any patient who developed clinical radiation pneumonitis from their course of chemoradiation prior to protocol treatment.
  • Direct evidence of regional or distant metastases after appropriate staging studies.
  • Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery). Patients may receive antineoplastic therapy at the discretion of their treating physician beginning 6 weeks after completion of protocol therapy.
  • Patients with active systemic, pulmonary, or pericardial infection.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
  • Major illness or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and /or interfere with follow-up.

About this study

Official title: 0516 GCC: Stereotactic Body Radiation Therapy As A Boost After Definitive Treatment With Concurrent Chemoradiation In Patients With Non-Small Cell Lung Cancer

SBRT to deliver a boost dose to residual primary tumor after definitive doses of standard EBRT have been delivered concurrently with chemotherapy.

Serum levels of TGF-Beta1 and correlation with SBRT toxicity.

Read the detailed description

This protocol is designed to use stereotactic body radiation therapy (SBRT) to deliver a boost dose to residual primary tumor after definitive doses of standard external beam radiation have been delivered concurrently with chemotherapy. It is designed to determine the toxicity profile(side effects) in the context of dose escalation of stereotactic body radiation therapy (SBRT) after definitive therapy with concurrent chemoradiation and to define the maximum tolerated dose.

Serum levels of TGF-Beta1 have been demonstrated to correlate with the incidence of the radiation toxicity, pneumonitis in patients treated with standard external beam radiation. This study will serially follow TGF-Beta1 levels in patients to see if the same correlation exists with SBRT toxicity.

Being tested
SBRT
Keywords
IIIA, selected IIIB, (T1N2-3M0, T2N2-3M0, T3N1-3M0)
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.

  • SBRTRadiation

    SBRT x 3 (start 6-9 weeks following standard ChemoRT; Time between SBRT Boost treatments: 40 hours to 8 days)

    Dose Escalation Schema:

    Cohort -3: 4 Gy x3 Cohort -2: 5 Gy x3 Cohort -1: 6 Gy x3 If de-escalation is required after initial cohort

    Cohort 1: 7 Gy x 3 INITIAL COHORT Cohort 2: 8 Gy x 3 Cohort 3: 9 Gy x 3

    Continue +1 Gy x 3 until reach MTD

Study groups in NCT00818714
Study groupRoleWhat they receive
1ExperimentalDose escalation study to define the maximum tolerated boost dose of stereotactic body radiation therapy (SBRT) to the residual primary tumor after definitive therapy with concurrent chemotherapy and external beam radiation.
Receives: Radiation: SBRT

What is being measured

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

  1. To determine the toxicity profile in the context of dose escalation of stereotactic body radiation therapy (SBRT) after definitive therapy with concurrent chemoradiation and to define the maximum tolerated dose.

    Measured: Follow-up Post-SBRT: 2, 4, 6,12 weeks, every 3 months for 2 years, every 6 months for 2 years, then at the discretion of the treating M.D.

Secondary outcomes (1)

  1. To study the incidence of the radiation toxicity, pneumonitis in patients treated with SBRT by serially following TGF-Beta1 levels.

    Measured: Prestudy thru post SBRT week 12

Timeline

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

  1. First posted8 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionOct 2009
  4. Study completionOct 2009

Why it stopped: There was no patient accrual nor study activity due to inability to fund PFTs.

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00818714
Sponsor's protocol ID
HP-00040255
Other IDs
GCC 0516
Status last verified
Mar 2020
First submitted
7 Jan 2009
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBRT in people with Non-Small Cell Lung Cancer (NSCLC), run by University of Maryland, Baltimore.

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 27 inclusion and 8 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

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 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?

To determine the toxicity profile in the context of dose escalation of stereotactic body radiation therapy (SBRT) after definitive therapy with concurrent chemoradiation and to define the maximum tolerated dose. (time frame: Follow-up Post-SBRT: 2, 4, 6,12 weeks, every 3 months for 2 years, every 6 months for 2 years, then at the discretion of the treating M.D.). 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 NCT00818714.

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 18 Mar 2020.

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