High-Dose or Standard-Dose Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

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High-Dose or Standard-Dose Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2009
Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Cancer and Leukemia Group B

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00533949

Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying high-dose radiation therapy given together with cetuximab and chemotherapy to see how well it works compared with standard-dose radiation therapy and chemotherapy in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.



Condition Intervention Phase
Cancer-Related Problem/Condition
Lung Cancer
Biological: cetuximab
Drug: carboplatin
Drug: paclitaxel
Radiation: 3-dimensional conformal radiation therapy
Phase III




MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy Surgery
Drug Information available for: Carboplatin Paclitaxel Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Overall (Failure: death from any cause) survival [ Designated as safety issue: No ]



Secondary Outcome Measures:
Progression-free survival (Failure: occurrence of local or regional progression, distant metastases, or death from any cause) [ Designated as safety issue: No ]

Local-regional failure (Failure: occurrence of local or regional progression) [ Designated as safety issue: No ]

Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Death during or within 30 days of discontinuation of protocol treatment [ Designated as safety issue: Yes ]

Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) and lung cancer subscale (LCS) [ Designated as safety issue: No ]

Patient-reported swallowing ability [ Designated as safety issue: No ]

Quality-adjusted survival based on EuroQoL (EQ5D)-derived health utility score [ Designated as safety issue: No ]

Correlation of tumor markers with overall survival, local-regional failure, and QOL [ Designated as safety issue: No ]

Prognostic and predictive effects of gross tumor volume on overall survival [ Designated as safety issue: No ]

Prognostic value of pre-treatment standardized uptake value (SUV) of PET scan in predicting survival, distant metastasis, and local-regional control [ Designated as safety issue: No ]


Estimated Enrollment: 500
Study Start Date: November 2007
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Active Comparator
Patients undergo standard-dose radiotherapy 5 days a week for 6 weeks. Patients receive concurrent chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 35 and 42. Patients also receive consolidation treatment of paclitaxel and carboplatin. Treatment repeats in the absence of disease progression or unacceptable toxicity. Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel
Given IV over 1 hour
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week
Arm II: Experimental
Patients undergo high-dose radiotherapy 5 days per week for 7.5 weeks. Patient also receive concurrent paclitaxel and carboplatin and receive consolidation treatment as in Arm I. Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel
Given IV over 1 hour
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week
Arm III: Experimental
Patients undergo standard-dose radiotherapy as in Arm I. Patients receive cetuximab and receive concurrent chemotherapy and consolidation treatment comprising cetuximab, paclitaxel, and carboplatin periodically for up to 16 weeks. Biological: cetuximab
Given IV
Arm IV: Experimental
Patients undergo high-dose radiotherapy as in arb II and receive concurrent cetuximab, concurrent chemotherapy, and consolidation treatment as in Arm III. Biological: cetuximab
Given IV


Show Detailed Description


Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer (NSCLC)

Stage IIIA or IIIB disease

N3 supraclavicular disease or contralateral hilar lymph node involvement (i.e. greater than 1.5 cm on short axis or positive on PET scan) not allowed
Unresectable or inoperable disease
No distant metastases
No Pancoast tumors
No planned treatment with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus
Pleural effusion allowed provided effusion is minimal and none of the following conditions are present:

Cytologically positive pleural effusion detectable by CT scan and chest x-ray (pleuracentesis required to confirm negative cytology of pleural fluid)
Greater than minimal pleural effusions (minimal effusions not detectable by chest x-ray and too small to tap safely are allowed)
Exudative pleural effusions, regardless of cytology
Malignant pleural effusion (T4 incurable disease)
Measurable or evaluable disease
PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
ANC ≥ 1,800 cells/mm³
Platelet count ≥ 100,000 cells/mm³
Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
Creatinine normal OR creatinine clearance ≥ 60 mL/min
Bilirubin normal
AST and ALT < 2.5 times upper limit of normal
PFTs including FEV1 &#8805; 1.45 L/sec (best value obtained prior to or after use of bronchodilator)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective protection
No uncontrolled neuropathy &#8805; grade 2
Patients with post-obstructive pneumonia allowed
No prior invasive malignancy, except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix, unless the patient has been disease-free for the past 3 years
No prior severe infusion reaction to a monoclonal antibody
No weight loss of &#8805; 10% within the past 4 weeks
No history of allergic reaction to paclitaxel or other taxanes, or to carboplatin
No severe, active comorbidity, including any of the following:

Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
Transmural myocardial infarction within the past 6 months
Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or within past 30 days precluding study therapy
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
AIDS
No significant history of uncontrolled cardiac disease, including any of the following:

Uncontrolled hypertension
unstable angina
Myocardial infarction within the past 6 months
Uncontrolled congestive heart failure
Cardiomyopathy with decreased ejection fraction
PRIOR CONCURRENT THERAPY:

At least 3 weeks since prior exploratory thoracotomy (if performed)
Prior systemic chemotherapy allowed, provided it was not given for NSCLC
No prior therapy that specifically and directly targets the EGFR pathway
No prior radiotherapy to the region of NSCLC that would result in overlap of radiotherapy fields
No concurrent WBC growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) given during radiotherapy or prophylactically during consolidation chemotherapy
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533949

Show 57 Study Locations

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Investigators
Principal Investigator: Jeffrey Bradley, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
Investigator: Hak Choy, MD Simmons Cancer Center
Investigator: Gregory A. Masters, MD CCOP - Christiana Care Health Services
Study Chair: Steven E. Schild, MD Mayo Clinic Scottsdale
Investigator: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
Study Chair: Jeffrey A. Bogart, MD State University of New York - Upstate Medical University
Investigator: Arthur William Blackstock, MD Wake Forest University
Investigator: Mark A. Socinski, MD UNC Lineberger Comprehensive Cancer Center

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000564240, RTOG-0617, NCCTG-N0628, CALGB-30609
Study First Received: September 20, 2007
Last Updated: February 10, 2009
ClinicalTrials.gov Identifier: NCT00533949 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
radiation toxicity
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Cetuximab
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions



ClinicalTrials.gov processed this record on February 10, 2009


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