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TerminatedNCT00113386Updated Jun 28, 2013Results posted

Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer

A Phase 3 interventional study of filgrastim and pegfilgrastim in Lung Cancer, sponsored by Radiation Therapy Oncology Group. Terminated at 76 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-28.

Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment

Why this study was terminated
This study terminated early due to low accrual.
Phase
Phase 3
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving cisplatin and docetaxel together with radiation therapy is more effective than giving cisplatin together with docetaxel in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation therapy to see how well they work compared to cisplatin and docetaxel in treating patients who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare overall survival of patients with newly diagnosed favorable prognosis stage IIIA non-small cell lung cancer treated with neoadjuvant cisplatin and docetaxel with vs without thoracic conformal radiotherapy followed by surgical resection and docetaxel.

Secondary

  • Compare median and progression-free survival of patients treated with these regimens.
  • Compare clinical and pathologic response rates in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Correlate pathological complete response with disease-free and overall survival of patients treated with these regimens.
  • Correlate DNA damage repair genes (ERCC1 and XRCC1), microtubule-related proteins (TUBB-III and MAP4), and shed tumor DNA with response and outcome in patients treated with these regimens.
  • Correlate protein profiles, using MALDI-TOF proteomic analysis of tumor and serum, with response and prognosis in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Determine the efficacy of fludeoxyglucose F 18 positron emission tomography scanning in assessing pathological response of the tumor and the mediastinal lymph nodes and in predicting long-term outcome in patients treated with these regimens.
  • Correlate comorbid conditions with survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T1 vs T2-3), number of involved mediastinal lymph nodes (1 vs 2 or more vs not evaluable), and nodal micrometastases vs clinically involved nodes (mN2 vs cN2).

  • Induction therapy: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive cisplatin IV over 1 hour and docetaxel IV over 1 hour on days 1 and 22.
    • Arm II: Patients undergo thoracic conformal radiotherapy once daily 5 days a week for approximately 5½ weeks (total of 28 doses). Patients also receive cisplatin IV over 1 hour on days 1, 8, 22, and 29 and docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29.
  • Surgery: Within 4-8 weeks after completion of induction therapy, patients with stable disease or better undergo a lobectomy or pneumonectomy with a formal systematic mediastinal lymph node dissection.
  • Consolidation therapy: Beginning 4-6 weeks after surgery, patients receive docetaxel IV over 1 hour on days 1, 22, and 43 and pegfilgrastim or filgrastim (G-CSF) subcutaneously on days 2, 23, and 44.

Quality of life is assessed at baseline, within 2 weeks after completion of induction therapy, and then at 6 and 12 months after surgery.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 574 patients will be accrued for this study within 4 years.

02

Conditions studied

  • Lung Cancer

Keywords

  • stage IIIA non-small cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • squamous cell lung cancer
  • bronchoalveolar cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 19 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)*, including any of the following cellular types:

    • Adenocarcinoma
    • Squamous cell carcinoma
    • Large cell carcinoma
    • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
    • NSCLC not otherwise specified NOTE: *Diagnosed within the past 3 months; diagnosis by mediastinal nodal biopsy or needle aspiration allowed provided a distinct lung primary (separate from the nodes) is clearly evident on CT scan
  • Stage IIIA disease

    • T1-T3 disease

      • If pleural effusion is present, must meet ≥ 1 of the following criteria to exclude T4 disease:

        • Pleural effusion cytologically negative by thoracentesis
        • Documented absence of pleural metastases and pleural effusion cytologically negative by thoracoscopy (for patients with pleural effusion on CT scan [but not on chest x-ray] that is deemed too small to tap safely under either CT scan or ultrasound guidance)
    • Confirmed positive ipsilateral mediastinal lymph node(s) (N2 disease)**, with or without positive ipsilateral hilar nodes, by mediastinoscopy, mediastinotomy, endoscopic ultrasound-guided transesophageal biopsy, thoracotomy, video-assisted thoracoscopy, Wang needles, or fine needle aspiration under bronchoscopic or CT guidance

      • N2 nodes must be separate from primary tumor by CT scan or surgical exploration AND maximum diameter ≤ 3.0 cm
      • Mediastinoscopy OR other means of mediastinal lymph node biopsy required (regardless of the primary tumor site) for patients with subcarinal lymphadenopathy by size criteria or by positron emission tomography (PET) scan
      • If the lymph nodes in the contralateral mediastinum and neck are visible by contrast CT scan of the chest AND are ≥ 1.0 cm OR if contralateral involvement is suggested by PET scan, lymph nodes must be confirmed negative by one of the above diagnostic procedures AND N3 status must be confirmed negative by histology or cytology
      • No palpable lymph nodes in the supraclavicular areas or higher in the neck unless proven benign by excisional biopsy
      • A nodal biopsy or needle aspiration may be omitted provided all of the following criteria are true:

        • Paralyzed left true vocal cord by bronchoscopy or indirect laryngoscopy
        • Nodes visible in the aortopulmonary window (level 5) region on CT scan
        • Distinct primary tumor (separate from the nodes) is visible by CT scan
        • No evidence of subcarinal nodal involvement by CT scan NOTE: **PET scan positivity is not sufficient to establish N2 nodal status
  • Measurable disease by chest x-ray and/or contrast-enhanced CT scan
  • Candidate for surgery

    • Resectable disease
  • No distant metastases, including other ipsilateral or contralateral parenchymal lesions or liver or adrenal metastases, by history or physical examination, fludeoxyglucose F 18 PET scan, MRI or CT scan of the brain, chest x-ray and/or CT scan of the lungs and upper abdomen

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,800/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

Hepatic

  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No hepatic insufficiency resulting in clinical jaundice or coagulation defects

Renal

  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No unstable angina or congestive heart failure requiring hospitalization within the past 6 months
  • No transmural myocardial infarction within the past 6 months

Pulmonary

  • FEV_1 ≥ 2.0 L OR
  • Predicted post-resection FEV_1 ≥ 0.8 L
  • DLCO ≥ 50% of predicted
  • No chronic obstructive pulmonary disease exacerbation
  • No other respiratory illness requiring hospitalization or that would preclude study therapy

Immunologic

  • No AIDS
  • No prior allergic reaction to the study drugs
  • No history of severe hypersensitivity to other drugs formulated with polysorbate 80
  • No acute bacterial or fungal infection requiring IV antibiotics

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No unintentional weight loss > 5% of body weight within the past 6 months
  • No pre-existing peripheral neuropathy ≥ grade 2
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No other severe active comorbidity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biological agent for this cancer
  • No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim during study induction therapy (for patients randomized to the chemoradiotherapy arm)

Chemotherapy

  • No prior systemic chemotherapy for this cancer

    • Prior chemotherapy for a different cancer allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
  • No routine post-operative radiotherapy
  • No concurrent intensity modulated radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No prior gefitinib for this cancer
  • No concurrent amifostine
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Other
    Induction chemotherapy, surgery, consolidation chemotherapy

    Induction/surgery/consolidation

    Biological: filgrastim · Biological: pegfilgrastim · Drug: cisplatin · Drug: docetaxel · Procedure: adjuvant therapy · Procedure: conventional surgery · Procedure: neoadjuvant therapy

  • Other
    Chemotherapy and radiation, surgery, consolidation ch

    Induction/radiation/surgery/cosolidation

    Biological: filgrastim · Biological: pegfilgrastim · Drug: cisplatin · Drug: docetaxel · Procedure: adjuvant therapy · Procedure: conventional surgery · Procedure: neoadjuvant therapy · Radiation: radiation therapy

Interventions

  • Biologicalfilgrastim

    Consolidation chemotherapy

  • Biologicalpegfilgrastim

    Consolidation chemotherapy

  • Drugcisplatin
  • Drugdocetaxel
  • Procedureadjuvant therapy
  • Procedureconventional surgery
  • Procedureneoadjuvant therapy
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Comparison of Overall Survival

    Time frame: Date of death or date of last follow-up

07

Results

Posted Dec 27, 2012
Limitations and caveats
This study terminated early with 19 out of 574 subjects accrued. Therefore no analysis was performed.

Participant flow

Participant flow — Overall Study
MilestonePreoperative Cisplatin/DocetaxelPreoperative Radiotherapy and Cisplatin/Docetaxel
Started109
Completed35
Not completed74
Withdrew: Withdrawal by subject10
Withdrew: Physician decision01
Withdrew: Toxicity30
Withdrew: Ineligible12
Withdrew: Unknown - lost to follow-up21

Outcome measures

PrimaryComparison of Overall Survival
Time frame:
Date of death or date of last follow-up

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Preoperative Cisplatin/Docetaxel—5/9 (55.6%)7/9 (77.8%)
Preoperative Radiotherapy and Cisplatin/Docetaxel—4/7 (57.1%)7/7 (100%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPreoperative Cisplatin/DocetaxelPreoperative Radiotherapy and Cisplatin/Docetaxel
Febrile neutropeniaBlood and lymphatic system disorders4/90/7
Neutrophil count decreasedInvestigations4/91/7
White blood cell decreasedInvestigations3/90/7
Atrial flutterCardiac disorders0/91/7
Colonic hemorrhageGastrointestinal disorders0/91/7
Rectal hemorrhageGastrointestinal disorders0/91/7
Wound dehiscenceInjury, poisoning and procedural complications0/91/7
HypoxiaRespiratory, thoracic and mediastinal disorders0/91/7
HypertensionVascular disorders0/91/7
HypotensionVascular disorders1/91/7
Most frequent other events
Showing 10 of 97
Most frequent other events
EventPreoperative Cisplatin/DocetaxelPreoperative Radiotherapy and Cisplatin/Docetaxel
NauseaGastrointestinal disorders5/96/7
FatigueGeneral disorders6/96/7
AnorexiaMetabolism and nutrition disorders3/95/7
AnemiaBlood and lymphatic system disorders6/94/7
EsophagitisGastrointestinal disorders0/94/7
VomitingGastrointestinal disorders2/94/7
HyponatremiaMetabolism and nutrition disorders4/94/7
DyspneaRespiratory, thoracic and mediastinal disorders3/94/7
DiarrheaGastrointestinal disorders5/91/7
Aspartate aminotransferase increasedInvestigations4/91/7

Baseline characteristics

Age Continuous
Age Continuous(years)Preoperative Cisplatin/DocetaxelPreoperative Radiotherapy and Cisplatin/DocetaxelTotal
Median66 (43 to 77)57 (45 to 72)63 (43 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Preoperative Cisplatin/DocetaxelPreoperative Radiotherapy and Cisplatin/DocetaxelTotal
Female246
Male639
08

Study locations

76 sites
  • Cancer Center at Providence Alaska Medical Center
    Anchorage, Alaska 99519-6604, United States
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Cancer Care Center at John Muir Health - Concord Campus
    Concord, California 94524-4110, United States
  • Moores UCSD Cancer Center
    La Jolla, California 92093-0658, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90089-9181, United States
  • University of California Davis Cancer Center
    Sacramento, California 95817, United States
  • Memorial Hospital
    Colorado Springs, Colorado 80909, United States
  • Front Range Cancer Specialists
    Fort Collins, Colorado 80524, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
    Jupiter, Florida 33458, United States
  • Watson Clinic, LLC
    Lakeland, Florida 33804-5000, United States
  • CCOP - Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital
    Albany, Georgia 31701, United States
  • CCOP - Atlanta Regional
    Atlanta, Georgia 30342, United States
  • Northeast Georgia Medical Center
    Gainesville, Georgia 30501, United States
  • Delnor Community Hospital - Geneva
    Geneva, Illinois 60134, United States
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Community Cancer Center
    Normal, Illinois 61761, United States
  • Advocate Christ Medical Center
    Oak Lawn, Illinois 60453-2699, United States
  • Cancer Treatment Center at Pekin Hospital
    Pekin, Illinois 61554, United States
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
    Peoria, Illinois 61615, United States
  • OSF St. Francis Medical Center
    Peoria, Illinois 61637, United States
  • Cancer Institute at St. John's Hospital
    Springfield, Illinois 62702, United States
  • Reid Hospital & Health Care Services, Incorporated
    Richmond, Indiana 47374, United States
  • Memorial Hospital of South Bend
    South Bend, Indiana 46601, United States
  • Hematology Oncology Associates of the Quad Cities
    Bettendorf, Iowa 52722, United States
  • Genesis Regional Cancer Center at Genesis Medical Center
    Davenport, Iowa 52803, United States
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
    Lexington, Kentucky 40536-0293, United States
  • St. Agnes Hospital Cancer Center
    Baltimore, Maryland 21229, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231-2410, United States
  • Frederick Memorial Hospital Regional Cancer Therapy Center
    Frederick, Maryland 21701, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • CCOP - Michigan Cancer Research Consortium
    Ann Arbor, Michigan 48106, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0942, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • Upper Michigan Cancer Center at Marquette General Hospital
    Marquette, Michigan 49855, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • St. John's Regional Medical Center
    Joplin, Missouri 64804, United States
  • St. John's Regional Health Center
    Springfield, Missouri 65804, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital
    St Louis, Missouri 63110, United States
  • Good Samaritan Cancer Center at Good Samaritan Hospital
    Kearney, Nebraska 68848-1990, United States
  • Methodist Cancer Center at Methodist Hospital - Omaha
    Omaha, Nebraska 68114, United States
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    Omaha, Nebraska 68198-6805, United States
  • Valley Hospital - Ridgewood
    Ridgewood, New Jersey 07450, United States
  • NYU Cancer Institute at New York University Medical Center
    New York, New York 10016, United States
  • SUNY Upstate Medical University Hospital
    Syracuse, New York 13210, United States
  • Faxton Regional Cancer Center
    Utica, New York 13502, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Leo W. Jenkins Cancer Center at ECU Medical School
    Greenville, North Carolina 27835-6028, United States
  • Lenoir Memorial Cancer Center
    Kinston, North Carolina 28501, United States
  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
    Pinehurst, North Carolina 28374, United States
  • Charles M. Barrett Cancer Center at University Hospital
    Cincinnati, Ohio 45267, United States
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    Columbus, Ohio 43210-1240, United States
  • Veterans Affairs Medical Center - Portland
    Portland, Oregon 97207, United States
  • Oregon Health & Science University Cancer Institute
    Portland, Oregon 97239-3098, United States
  • St. Luke's Hospital Cancer Center
    Bethlehem, Pennsylvania 18015, United States
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
  • Lancaster General Hospital
    Lancaster, Pennsylvania 17604, United States
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    Philadelphia, Pennsylvania 19107-5541, United States
  • Albert Einstein Cancer Center
    Philadelphia, Pennsylvania 19141, United States
  • Allegheny Cancer Center at Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • York Cancer Center at Apple Hill Medical Center
    York, Pennsylvania 17405, United States
  • Hollings Cancer Center at Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • CCOP - Greenville
    Greenville, South Carolina 29615, United States
  • CCOP - Upstate Carolina
    Spartanburg, South Carolina 29303, United States
  • U.T. Cancer Institute at University of Tennessee Medical Center
    Knoxville, Tennessee 37920-6999, United States
  • Medical City Dallas Hospital
    Dallas, Texas 75230, United States
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    Dallas, Texas 75390, United States
  • CCOP - Virginia Mason Research Center
    Seattle, Washington 98101, United States
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    Seattle, Washington 98122-4307, United States
  • Madigan Army Medical Center - Tacoma
    Tacoma, Washington 98431, United States
  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
    Green Bay, Wisconsin 54311, United States
  • Dean Medical Center - Madison
    Madison, Wisconsin 53717, United States
  • Vince Lombardi Cancer Clinic - Sheboygan
    Sheboygan, Wisconsin 53081, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00113386
Lead sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), SWOG Cancer Research Network, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, North Central Cancer Treatment Group
Responsible party
Sponsor
First posted
Jun 8, 2005
Start date
Apr 2005
Primary completion
Feb 2009
Results posted
Dec 27, 2012
Last update
Jun 28, 2013

Study contacts

Maria Werner-Wasik, MD
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University
Howard L. West, MD
principal investigator · Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Jeffrey Crawford, MD
study chair · Duke Cancer Institute
Chandra P. Belani, MD
study chair · University of Pittsburgh
James R. Jett, MD
study chair · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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