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

NCT02262325 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: OSU-14091NCI-2014-01663
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Keywords

Non-small cell; Lung Cancer; Chemoradiation

Outcome Measures

Primary Outcomes (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.

  At 12 months following chemo/radiation therapy

Secondary Outcomes (11)

• Number of Adverse Events

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

• Tolerability Measured by the Number of Patients Who Discontinue Treatment

  Up to 5 years

• Regional Control

  Up to 24 months

• Distant Control

  Up to 24 months

• Disease-free Survival (DFS)

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

Study Arms (1)

Treatment (hypofractionated radiation boost, chemoradiation)

EXPERIMENTAL

Patients 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.

Radiation: hypofractionated radiation therapy; Drug: cisplatin; Drug: etoposide; Radiation: 3-dimensional conformal radiation therapy; Other: laboratory biomarker analysis

Interventions

hypofractionated radiation therapy RADIATION

Radiation boost in week 1 (days 1-5)

Also known as: SBRT

Treatment (hypofractionated radiation boost, chemoradiation)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (hypofractionated radiation boost, chemoradiation)

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Treatment (hypofractionated radiation boost, chemoradiation)

3-dimensional conformal radiation therapy RADIATION

Undergo 3-dimensional conformal radiation therapy

Also known as: 3D conformal radiation therapy, 3D-CRT

Treatment (hypofractionated radiation boost, chemoradiation)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (hypofractionated radiation boost, chemoradiation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Cisplatin; Etoposide; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Eric Miller
• Organization: The Ohio State University Comprehensive Cancer Center

eric.miller@osumc.edu

614-293-8595

Study Officials

• Eric Miller, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 13, 2014
• Study Start: June 8, 2015
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)