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Recurrent Lung Non-Small Cell CarcinomaPhase 1/2NCT01629498

Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer

A Phase 1/2 study testing Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Recurrent Lung Non-Small Cell Carcinoma and Stage II Non-Small Cell Lung Cancer AJCC v7, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteUnited States
Study dates
17 Sep 2012to 30 Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection or stereotactic body radiation therapy (SBRT) non-small cell lung cancer
  • Suitability for concurrent chemoradiation therapy per treating physician's assessment
  • Karnofsky performance status (KPS) score >= 70
  • Weight loss < 15% in the 3 months before diagnosis
  • Prior receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed
  • Adequate lung function indicated by forced expiratory volume at 1 second (FEV1) >= 1 L is required
Show all 16Show fewer
  • The primary tumor and/or regional lymph nodes must be evaluable radiographically
  • The gross target volume (GTV) is suitable for motion management using 4 dimensional computed tomography (4D CT), internal target volume (ITV), or respiratory gating; in addition, the target coverage and normal tissue constraints must be met as specified in protocol accounting for the respiratory motion of anatomy as a whole (not just the tumor)
  • No prior radiation to the mediastinal structures
  • Hemoglobin >= 9.0 g/dL
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Total bilirubin =< 1.5 times the upper limit of normal (ULN)
  • Alanine and aspartate transaminases (ALT and AST) =< 2.5 times the ULN (=< 5 x ULN for patients with liver involvement)
  • Creatinine =< 1.5 times ULN
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of MD Anderson Cancer Center (MDACC)

Who cannot join

  • Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)
  • T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart
  • Pregnancy
  • Patients of childbearing potential must practice appropriate contraception
  • Patient refusal

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I/II Trial of Image-Guided, Intensity-Modulated Photon (IMRT) or Scanning Beam Proton Therapy (IMPT) Both With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-Small Cell Lung Cancer (NSCLC)

This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. This trial is testing a new way of delivering radiation dose when only the tumor receives dose escalation while the surrounding normal structure is kept at standard level. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator (linac). The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. 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. Both methods are designed to give a higher than standard dose of treatment to the tumor and may reduce the amount of radiation damage to healthy tissue near a tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the maximum tolerated dose (MTD) of image-guided intensity-modulated photon (IMRT) and proton therapy (IMPT) both with simultaneous integrated boost (SIB) dose escalation to the SIBVi (internal SIB volume; defined as the gross tumor volume with consideration of respiratory motion plus setup uncertainty margin) for patients with stage II/IIIB non-small cell lung cancer (NSCLC) receiving concurrent standard chemotherapy and proton irradiation. (Phase I) II. Assess and compare survival free of grade III treatment related toxicity and local progression-free survival from day 1 of concurrent chemoradiation for stage II-IIIB NSCLC patients treated with image-guided robustly-optimized IMPT versus (vs.) IMRT, both delivered with simultaneous integrated boost (SIB). (Phase II)

SECONDARY OBJECTIVES:

  1. Determine treatment-related acute and late toxicity. II. Correlate changes in standardized uptake values (SUV) on positron emission tomography (PET) and study endpoints (toxicity, tumor response, local control).

III. Correlate changes in peripheral blood biomarkers (genes, micro-ribonucleic acid [RNA], proteins) and the study endpoints.

IV. Estimate progression-free and overall survival. V. Document and compare symptom burden before starting chemoradiation, weekly during treatment, bi-weekly from end of treatment until first follow up, and at each follow-up visit thereafter by using the MD Anderson Symptom Inventory - Plus (MDASI-Plus) and European Quality of Life Instrument-5 dimensions (EQ-5D).

VI. Perform cost effectiveness between IMPT and IMRT both with SIB treatment. VII. Correlate imaged response, clinical response, blood biomarkers and symptom burdens to dose distribution patterns.

OUTLINE: This is a phase I, dose-escalation study followed by a randomized phase II study.

PHASE I: Patients undergo image-guided IMRT with SIB or IMPT with SIB once daily (QD) 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo image-guided IMRT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo image-guided IMPT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4-8 weeks, every 3-4 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Being tested
Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Photon Beam Radiation Therapy, Proton Beam Radiation Therapy
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.

  • Image Guided Radiation TherapyRadiation

    Also called IGRT, image-guided radiation therapy

    Undergo image-guided IMRT

  • Image Guided Radiation TherapyRadiation

    Also called IGRT, image-guided radiation therapy

    Undergo image-guided IMPT

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo image-guided IMRT

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo image-guided IMPT

  • Laboratory Biomarker AnalysisOther

    Optional correlative studies

  • Photon Beam Radiation TherapyRadiation

    Undergo image-guided IMRT

  • Proton Beam Radiation TherapyRadiation

    Also called PBRT, Proton Radiation Therapy

    Undergo image-guided IMPT

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT01629498
Study groupRoleWhat they receive
Arm I (image-guided IMRT)ExperimentalPatients undergo image-guided IMRT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Radiation: Photon Beam Radiation Therapy; Other: Questionnaire Administration
Arm II (image-guided IMPT)ExperimentalPatients undergo image-guided IMPT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Radiation: Proton Beam Radiation Therapy; Other: Questionnaire Administration

What is being measured

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

  1. Maximum tolerated dose (MTD) for intensity-modulated photon therapy (IMRT) (Phase I)

    Will be defined as the highest simultaneous integrated boost volume (SIBV) dose that has posterior probability of dose-limiting toxicity (DLT) =< 30%. DLT are defined as Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy.

    Measured: 90 days

  2. MTD for intensity-modulated proton therapy (IMPT) (Phase I)

    Will be defined as the highest SIBV dose that has posterior probability of DLT =< 30%. DLT are defined as CTCAE 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy.

    Measured: 90 days

  3. Survival free of grade >= 3 toxicity (with a target of at least 75%) (Phase II)

    Measured: 6 months

  4. Local progression-free survival (75% at 6 months) d (Phase II)

    Will be defined as tumor recurrence or progression inside or at the boundary of the volume defined by the 60 Gy (relative biological effectiveness) isodose line. A Bayesian method will be applied.

    Measured: 6 months

Secondary outcomes (7)

  1. Time to local failure (Phase II)

    The product-limit estimator of Kaplan and Meier will be used.

    Measured: Up to 5 years

  2. Progression-free survival (Phase II)

    The product-limit estimator of Kaplan and Meier will be used.

    Measured: Up to 5 years

  3. Overall survival (Phase II)

    The product-limit estimator of Kaplan and Meier will be used.

    Measured: Up to 5 years

  4. Posterior probability that the DLT rate 90 days from day 1 of radiation therapy is more than 30% (Phase II)

    A 90% credible interval will be reported for this rate. Toxicities will be tabulated by severity and relationship to radiation therapy.

    Measured: 90 days

  5. Changes in selected biomarkers (Phase II)

    Correlate changes in peripheral blood biomarkers (genes, ctDNA, microRNA, exosomes, proteins) and the study endpoints. Cox proportional hazards regression will be used to estimate the relationship between changes in selected biomarkers and time to local failure, progression-free survival, and overall survival.

    Measured: Baseline to up to 5 years

  6. Change in symptom burden using European Quality of Life Five Dimension [EQ-5D]) (Phase II) Survey

    Descriptive statistics and box plots will be used and will be measured by participants answers to the survey.

    Measured: Up to 10 minutes

  7. Change in symptom burden using MD Anderson Symptom Inventory [MDASI]-Plus Survey

    Descriptive statistics and box plots will be used and will be measured by participants answers to the survey.

    Measured: Up to 10 minutes

Timeline

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

  1. First posted27 Jun 2012 (estimated)
  2. Study start17 Sep 2012
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01629498
Sponsor's protocol ID
2011-1058
Other IDs
NCI-2012-01224, 2011-1058, P01CA021239, U19CA021239
Status last verified
Sep 2026
First submitted
25 Jun 2012
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Recurrent Lung Non-Small Cell Carcinoma and Stage II Non-Small Cell Lung Cancer AJCC v7, run by M.D. Anderson Cancer Center 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 16 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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) for intensity-modulated photon therapy (IMRT) (Phase I) (time frame: 90 days). The study lists 4 primary outcomes in all. 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 NCT01629498.

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 16 Sep 2026.

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Clinical Trial NCT01629498 | AzTrials