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Recurrent Non-small Cell Lung CancerPhase 2NCT02262325

Hypofractionated Boost Before Chemoradiation for Patients With Stage II-III Non-small Cell Lung Cancer Unsuitable for Surgery

A Phase 2 study testing hypofractionated radiation therapy, cisplatin and etoposide in people with Recurrent Non-small Cell Lung Cancer and Stage IIA Non-small Cell Lung Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well giving a hypofractionated boost to the primary tumor before standard chemotherapy and radiation therapy works in treating patients with stage II or III 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?
hypofractionated radiation therapy, cisplatin and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
8 Jun 2015to 15 Apr 2024
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment
  • Adequate baseline organ function obtained within 30 days of study registration
  • Absolute neutrophil count >= 1.5 x 10^9/L
  • Hemoglobin >= 9 g/dL
  • Platelets >= 100 x 10^9/L
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
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  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  • Creatinine =< 1.5 ULN AND
  • Calculated creatinine >= 50 mL/min (calculated by the Cockcroft-Gault formula) or
  • 24-hour urine creatinine clearance >= 50 mL/min
  • Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven
  • Clinical American Joint Committee on Cancer (AJCC) stage (7th edition) IIA-IIIB NSCLC (T1-4N1-3M0)
  • Patients must be considered unresectable or medically-inoperable
  • Patients must have primary tumor =< 6 cm as defined by CT largest axial dimension
  • Within 60 days of registration: patients must have fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-CT scan (or CT chest/abdomen/pelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (or CT scan of the brain with contrast); a non-contrast MRI scans of the chest/abdomen/pelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency
  • Within 30 days of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count panel [CBCP] with differential, chemistries including liver function tests, creatinine clearance [CrCl] assessment, pregnancy test if needed within 14 days of registration)
  • If a pleural effusion is present and visible on both CT scan AND chest x-ray, the investigator should exclude malignant disease by pleurocentesis to confirm cytologically-negative pleural fluid; if fluid is exudative or cytologically positive for tumor cells, patient is excluded
  • Patients with effusions that are minimal (i.e. not visible on chest x-ray) and that are too small to safely tap are eligible.
  • Life expectancy of at least 12 weeks in the opinion of investigator
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 30 days of registration
  • Patients must have measurable primary tumor (undetectable NSCLC primary tumor is ineligible)
  • Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment
  • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration; urine human gonadotropin (HCG) is an acceptable pregnancy assessment
  • Nursing women may participate only if nursing is discontinued
  • Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment

Who cannot join

  • Patients with contralateral hilar involvement (greater than 1.5 cm on short axis or positive on PET scan, or biopsy-proven)
  • Documented or pathologically-proven metastatic disease
  • Presence of nodules considered neoplastic in the same lobe or other ipsilateral lobe as the primary tumor (stage T3-4), unless the nodule can be encompassed in the stereotactic boost (gross tumor volume [GTV]boost) without exceeding a total GTVboost size of 6 cm as defined by CT largest axial dimension
  • Presence of nodules considered neoplastic in contralateral lobes (M1a)
  • Patients with history of pneumonectomy
  • Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib, crizotinib), unless > 2 years prior
Show all 18Show fewer
  • Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trial
  • History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
  • History of previous radiation therapy which would result in overlapping radiation fields
  • Uncontrolled neuropathy grade 2 or greater, regardless of cause
  • Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds) [first 10 patients]
  • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator; this could include severe, active co-morbidities such as:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last months
  • Transmural myocardial infarction within the last 6 months
  • Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition; note, however, that HIV testing is not required for entry to protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved may be significantly immunosuppressive
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
  • Hepatic insufficiency resulting in jaundice and/or coagulation defects

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase II Trial Combining Hypofractionated Radiation Boost With Conventionally-Fractionated Chemoradiation in Locally Advanced Non-small Cell Lung Cancer Not Suitable for Surgery

This phase II trial studies how well giving a hypofractionated boost to the primary tumor before standard chemotherapy and radiation therapy works in treating patients with stage II or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation oncology have allowed better radiation targeting which may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and targeted radiation before standard chemotherapy and radiation therapy may kill more tumor cells and prevent the cancer from coming back in the location in which it started.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the primary tumor control rate at 12 months.

SECONDARY OBJECTIVES:

  1. To further establish safety and tolerability of this regimen. II. To estimate the rates of regional, distant control as well as progression-free survival and overall survival.

III. To evaluate the objective response rate (ORR) to this regimen. IV. To evaluate the response of tumors to stereotactic (high-dose) radiation using magnetic resonance tumor perfusion imaging modalities (magnetic resonance [MR]-dynamic contrast-enhanced [DCE]/perfusion weighted imaging [PWI], MR-diffusion, blood oxygenation level dependent [BOLD] sequences).

OUTLINE:

Patients will receive a hypofractionated boost to the primary tumor over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin intravenously (IV) on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. If carboplatin and paclitaxel is administered concurrently with radiotherapy, 2 cycles of carboplatin (AUC=6 mg/min/mL IV on day 1, 22) and paclitaxel (200 mg/m2 IV on day 1, 22) consolidation chemotherapy are required, to be administered starting 4-6 weeks after concurrent chemoradiation has ended. Each cycle is 21 days long. If cisplatin and etoposide is administered concurrently with radiotherapy, consolidation chemotherapy is not allowed. Patients also undergo standard conformal radiation therapy once daily (QD) 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
hypofractionated radiation therapy, cisplatin, etoposide, 3-dimensional conformal radiation therapy, laboratory biomarker analysis
Keywords
Non-small cell, Lung Cancer, Chemoradiation
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.

  • hypofractionated radiation therapyRadiation

    Also called SBRT

    Radiation boost in week 1 (days 1-5)

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • 3-dimensional conformal radiation therapyRadiation

    Also called 3D conformal radiation therapy, 3D-CRT

    Undergo 3-dimensional conformal radiation therapy

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02262325
Study groupRoleWhat they receive
Treatment (hypofractionated radiation boost, chemoradiation)ExperimentalPatients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: hypofractionated radiation therapy; Drug: cisplatin; Drug: etoposide; Radiation: 3-dimensional conformal radiation therapy; Other: laboratory biomarker analysis

What is being measured

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

  1. Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure

    Primary tumor control rate at 12 months, as well its 95% confidence interval, will be reported for all eligible subjects received treatment.

    Measured: At 12 months following chemo/radiation therapy

Secondary outcomes (11)

  1. Number of Adverse Events

    Number of all adverse events with special attention to grade 3-5 esophagitis, pneumonitis, and cardiac adverse events as defined by the National Cancer Institution Common Terminology Criteria for Adverse Events CTCAE version 5.0

    Measured: Up to 30 days after completion of treatment, up to 5 years

  2. Tolerability Measured by the Number of Patients Who Discontinue Treatment

    The number of patients who discontinue treatment will be summarized.

    Measured: Up to 5 years

  3. Regional Control

    Regional control rate at 24 months will be reported for all eligible patients who received treatment.

    Measured: Up to 24 months

  4. Distant Control

    Distant control rate at 24 months will be reported for all eligible patients who received treatment

    Measured: Up to 24 months

  5. Disease-free Survival (DFS)

    Kaplan-Meier (K-M) analysis will be used to estimate DFS.

    Measured: From date of treatment initiation to progression, assessed up to 24 months

  6. Overall Survival (OS)

    K-M analysis will be used to estimate OS.

    Measured: Up to 24 months

  7. Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria

    Objective response rate will be reported for all eligible patients who receive treatment.

    Measured: At 3 months and 6 months

  8. Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep

    Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Amp, Kep.

    Measured: Baseline to the end of week 1

  9. Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel

    Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Kpe, Kel.

    Measured: Baseline to the end of week 1

  10. Changes in Diffusion Measured by MR-diffusion

    Changes in diffusion will be tested by comparing mean values of Apparent Diffusion Coefficient (ADC [× 10-3 mm2/s]) pre- and post-hypofractionated boost radiation using a paired t-test.

    Measured: Baseline to the end of week 1

  11. Changes in Hypoxia Measured by BOLD Sequences

    Changes in hypoxia will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.

    Measured: Baseline to the end of week 1

Timeline

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

  1. First posted13 Oct 2014 (estimated)
  2. Study start8 Jun 2015
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02262325
Sponsor's protocol ID
OSU-14091
Other IDs
NCI-2014-01663
Status last verified
May 2025
First submitted
7 Oct 2014
Last updated
12 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hypofractionated radiation therapy, cisplatin and etoposide in people with Recurrent Non-small Cell Lung Cancer and Stage IIA Non-small Cell Lung Cancer, run by Ohio State University Comprehensive 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 26 inclusion and 18 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: finished, as of the sponsor's last update on 12 Jun 2025. 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 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?

Yes. Results are posted in the registry (first posted 12 Jun 2025). 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?

Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure (time frame: At 12 months following chemo/radiation therapy). 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 NCT02262325.

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 12 Jun 2025.

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