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Trial record 1 of 1 for:    RTOG 0617
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High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Cancer and Leukemia Group B
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00533949
First received: September 20, 2007
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. 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. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.


Condition Intervention Phase
Lung Cancer
Radiation Toxicity
Biological: cetuximab
Drug: carboplatin
Drug: paclitaxel
Radiation: 3-dimensional conformal radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall (Failure: death from any cause) survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 339 deaths have been reported. ] [ 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) [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs after 339 deaths have been reported. ] [ Designated as safety issue: No ]
  • Local-regional failure (Failure: occurrence of local or regional progression) [ Time Frame: From randomization to date of local failure, death or last follow-up. Analysis occurs after 339 deaths have been reported. ] [ Designated as safety issue: No ]
  • Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
  • Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
  • Death during or within 30 days of discontinuation of protocol treatment [ Time Frame: From start of treatment to 24 months. ] [ 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) [ Time Frame: From start of treatment to 24 months. ] [ Designated as safety issue: No ]
  • Patient-reported swallowing ability [ Time Frame: From start of treatment to 24 months. ] [ Designated as safety issue: No ]
  • Quality-adjusted survival based on EuroQoL (EQ5D)-derived health utility score [ Time Frame: From start of treatment to 24 months. ] [ Designated as safety issue: No ]
  • Correlation of tumor markers with overall survival, local-regional failure, and QOL [ Time Frame: From randomization to date of failure (either local or regional), death or last follow-up. Analysis occurs after 339 deaths have been reported. ] [ Designated as safety issue: No ]
  • Prognostic and predictive effects of gross tumor volume on overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 339 deaths have been reported. ] [ 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 [ Time Frame: From randomization to date of failure (either local or regional), death or last follow-up. Analysis occurs after 339 deaths have been reported. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2007
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
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, and 36. 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 (arm II closed to accrual effective 6/17/11)
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week (arm II closed to accrual effective 6/17/11)
Experimental: Arm II
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 on days 1, 8, 15, 22, 29, 36 and 43. (closed to accrual effective 6/17/11)
Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel
Given IV over 1 hour (arm II closed to accrual effective 6/17/11)
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiation therapy 5 days a week (arm II closed to accrual effective 6/17/11)
Experimental: Arm III
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 closed to accrual effective 6/17/11)
Experimental: Arm IV
Patients undergo high-dose radiotherapy as in arm II and receive concurrent cetuximab, concurrent chemotherapy, and consolidation treatment as in Arm III. (closed to accrual effective 6/17/11)
Biological: cetuximab
Given IV (arm IV closed to accrual effective 6/17/11)

  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
      • N2 or N3 disease and an undetectable NSCLC primary tumor allowed
    • Unresectable or inoperable disease
  • No distant metastases
  • 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
  • Absolute neutrophil (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
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal
  • Pulmonary Function Test (PFTs) including forced expiratory volume at 1 sec. (FEV1) ≥ 1.2 L/sec or ≥ 50% predicted (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 ≥ grade 2
  • Patients with post-obstructive pneumonia allowed
  • Patients must speak English or Spanish in order to complete the mandatory EORTC QLQ-30 and PRO-CTCAE, which are only available in certain languages
  • 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 ≥ 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 white blood cell (WBC) growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) given during radiotherapy or prophylactically during consolidation chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 213 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
North Central Cancer Treatment Group
Cancer and Leukemia Group B
NRG Oncology
Investigators
Principal Investigator: Jeffrey Bradley, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair: Hak Choy, MD Simmons Cancer Center
Study Chair: Gregory A. Masters, MD CCOP - Christiana Care Health Services
Study Chair: Steven E. Schild, MD Mayo Clinic
Study Chair: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
Study Chair: Jeffrey A. Bogart, MD State University of New York - Upstate Medical University
Study Chair: Arthur William Blackstock, MD Comprehensive Cancer Center of Wake Forest University
Study Chair: Mark A. Socinski, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00533949     History of Changes
Other Study ID Numbers: RTOG 0617, CDR0000564240, NCCTG-N0628, CALGB-30609, NCI-2013-01762
Study First Received: September 20, 2007
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
radiation toxicity
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Radiation Injuries
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Wounds and Injuries
Carboplatin
Cetuximab
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014