AzTrials
AzTrials

Adenocarcinoma of the LungPhase 1NCT02059967

Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC

A Phase 1 study testing Paclitaxel, image-guided adaptive radiation therapy and carboplatin in people with Adenocarcinoma of the Lung and Large Cell Lung Cancer, run by Virginia Commonwealth University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This phase I trial studies the side effects and best dose of image-guided adaptive radiation therapy using active breathing control when given together with chemotherapy and simultaneous integrated boost in treating patients with stage IIA-IIIB non-small cell lung cancer that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paclitaxel, image-guided adaptive radiation therapy and carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2014to Jan 2015
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-proven (by biopsy or cytology), unresectable or inoperable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma not otherwise specified.
  • The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung 2.gif for staging.
  • All detectable tumor must be encompassed by radiation therapy fields.
  • 18-fluorodeoxyglucose PET is required for staging and treatment planning.
  • Atelectasis, if present, must involve less than a complete lung.
  • Laboratory values:
Show all 29Show fewer
  • Neutrophils >1500/µL
  • Platelets >100,000/µL
  • Bilirubin < 1.5 mg/dL
  • Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase [SGOT]) < 2x upper limit normal
  • Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase [SGPT]) < 2x upper limit normal
  • Serum creatinine < 2.0 mg/dL
  • Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days must be ≥ 59 mL/min
  • Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec
  • Plan of curative radiotherapy with or without concurrent chemotherapy.
  • Karnofsky Performance Scale score of ≥ 70%.
  • Age ≥ 18 years old.
  • Measurable disease on the planning CT.
  • Patient must have a completed IMRT plan to 66 Gy in 2 Gy fractions with ≥ 95% of the PTV covered by the prescription dose, and the attending physician must have reviewed and approved the DVHs as follows:
  • total lung V20 Gy ≤ 30%
  • mean esophageal dose ≤ 34 Gy
  • esophageal planning organs-at-risk volume (PRV) V60 Gy ≤ 30%
  • heart V40 Gy ≤ 50%
  • maximum brachial plexus dose ≤ 66 Gy
  • maximum spinal cord PRV dose ≤ 50 Gy
  • maximum aorta dose ≤ 66 Gy
  • maximum main bronchus dose ≤ 66 Gy
  • maximum dose ≥ 66 Gy allowed in only one lobar bronchus.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
  • Prior radiation therapy to the thorax.
  • Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past 5 years.
  • Clinically significant pleural effusions, pericardial effusions, or superior vena cava syndrome.
  • Oxygen supplementation required during therapy.
  • Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus.
Show all 11Show fewer
  • Tumors that affect more than one lobar bronchus, except the second involved bronchus in the right middle lobe bronchus.
  • Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm.
  • Myocardial infarction within the last 6 months, symptomatic heart disease, uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled bronchospasms.
  • History of a prior malignancy from which the patient has not been disease free for a minimum of 2 years, other than adequately treated basal/squamous skin cancer or in situ cervix cancer or other in situ malignancy.
  • Pregnant or lactating women.

About this study

Official title: A Phase I Image-Guided Adaptive Radiotherapy Study Using Active Breathing Control (ABC) and Simultaneous Integrated Boost for Patients With Inoperable Non-Small Cell Lung Cancer

This phase I trial studies the side effects and best dose of image-guided adaptive radiation therapy using active breathing control when given together with chemotherapy and simultaneous integrated boost in treating patients with stage IIA-IIIB non-small cell lung cancer that cannot be removed by surgery. Image-guided adaptive radiation therapy aims radiation therapy right at the tumor so that higher radiation doses can be given without causing bad side effects. Giving these higher doses may help control the tumor better. Breathing causes organs and tissues, including the tumor, to move within the chest. Active breathing control may reduce the volume that needs to be treated. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving image-guided adaptive radiation therapy using active breathing control with chemotherapy and simultaneous integrated boost may be an effective treatment for non-small cell lung cancer.

Read the detailed description

OUTLINE: This is a dose-escalation study of IGART.

Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.

After completion of study treatment, patients are followed up periodically for 5 years.

Being tested
Paclitaxel, image-guided adaptive radiation therapy, carboplatin
Keywords
Lung
Medical subject headings
Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PaclitaxelDrug

    Also called 5beta,20-epoxy-1,2alpha,4,7beta,10beta, 6,12b-bis(acetyloxy)-12-(benzoyloxy)-1a,33,4,-4, Anzatax, Asotax, Bristaxol, Praxel, TAX, Taxol, Taxol Konzentrat

    Given IV

  • image-guided adaptive radiation therapyRadiation

    Also called IGART, image-guided adaptive radiotherapy

    Undergo IGART

  • carboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA,, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, platinum, Ribocarbo

    Given IV

Study groups in NCT02059967
Study groupRoleWhat they receive
Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)ExperimentalPatients undergo IGART using ABC 5 days a week for 7 weeks, for a total of 33 fractions with SIVAB during fractions 26-33. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
Receives: Drug: Paclitaxel; Radiation: image-guided adaptive radiation therapy; Drug: carboplatin

What is being measured

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

  1. MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity

    (using daily image-guidance, deformable image registration, adaptive replanning at defined time points, and dose intensification at normal tissue tolerance) of radiotherapy delivered concomitantly with standard chemotherapy.

    Measured: 3 months

Secondary outcomes (4)

  1. Incidence of acute toxicity measured using the National Cancer Institution Common Terminology for Adverse Events version 4.0

    Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.

    Measured: Up to 90 days from radiation therapy start

  2. Incidence of late toxicity measured using the Radiation Therapy Oncology Group Late Radiation Morbidity Scoring

    Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.

    Measured: Up to 5 years

  3. Practicability of the approach

    Variations in respiratory patterns, tumor and CTV positions, as well as tumor volumes will be assessed on the respective under-treatment imaging studies. The feasibility of deformable image registration will be benchmarked against manual contours of targets and normal tissue. The practicability of IGART will be measured by assessing the necessary time, IT and personnel resources needed to conduct the study.

    Measured: Up to 5 years

  4. Tumor response evaluated according to Response Evaluation Criteria in Solid Tumors v1.1

    Measured: Up to 15 years

Timeline

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

  1. First posted11 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Due to no accrual.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059967
Sponsor's protocol ID
MCC-13-09209
Other IDs
HM20000101, MCC-20000101, NCI-2014-00163
Status last verified
Mar 2015
First submitted
7 Feb 2014
Last updated
19 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel, image-guided adaptive radiation therapy and carboplatin in people with Adenocarcinoma of the Lung and Large Cell Lung Cancer, run by Virginia Commonwealth University.

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 29 inclusion and 11 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 19 Mar 2015. 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?

MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity (time frame: 3 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 NCT02059967.

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 19 Mar 2015.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in