Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2008
End Date:November 2014

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Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

This study will compare the overall survival of participants with locally-advanced, Stage
III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.


Inclusion Criteria:

- Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type

- Participants must have measureable tumor lesions according to the Response Evaluation
Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on
computerized tomography (CT) scan

- Participants must be physically mobile, take care of themselves and must be up and
about and able to perform light activities, such as light housework or office work

- Participants must be 18 years of age or older

- Participants must have lost no more than 10% of their body weight in the previous 3
months

- Women must be sterile, postmenopausal, or on contraception, and men must be sterile
or on contraception

- Participants' test results assessing the function of their blood forming tissue,
kidneys, liver, and lungs must be satisfactory

- Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be
entered into this study. However, participants with cervical nodes are not permitted.
The upper border of supraclavicular nodes must not extend above the upper border of
the lateral end of the clavicle, extended medially.

Exclusion Criteria:

- Participants cannot have other on-going (uncontrolled) illnesses, including active
infections, recent heart problems, or psychiatric illnesses

- Participants who are unable to take vitamins (including injections of vitamin B12) or
oral cortisone medication

- Participants who have had a heart attack (myocardial infarction) or other cardiac
issues within 6 months of the trial

- Participants who have received other investigational drugs within the last 30 days

- Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily
basis or non-steroidal anti-inflammatory agents

- Participants who have diseases considered for surgical treatment as part of their
care plan, such as Pancoast or superior sulcus tumors

- Participants who had prior thoracic radiation. However, other prior radiotherapy is
allowed. Participants must have recovered from the toxic effects of the treatment
prior to study enrollment. Participants may not have received whole pelvis radiation
or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been
completed at least 30 days prior to study treatment.

- Participants who have a radiation treatment plan that would expose more than 35% of
the volume of their lung to 20 gray (Gy) or more of radiation

- Participants who have concurrent cancer from another primary site requiring treatment
of any kind within the past 5 years. Exemptions to this will be permitted on a
case-by-case basis after prior approval by the Sponsor physician or designate if the
investigator believes the participant's risk of recurrence and death is very low.
Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is
allowed. Participants with recurrence of a previously resected lung cancer or who
have a second primary lung cancer are ineligible.
We found this trial at
51
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331
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Columbia, MD
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164
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Ann Arbor, MI
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411
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Athens, GA
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925
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Bedford, TX
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492
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Birmingham, AL
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482
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Bronx, NY
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5386
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Buenos Aires,
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590
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Burlington, VT
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Charleston, South Carolina 29412
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Charleston, SC
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362
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Chattanooga, TN
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274
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Chicago, IL
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98
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Cincinnati, OH
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910
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Dallas, TX
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Duarte, CA
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280
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Evansville, IN
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643
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Fairhaven, MA
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857
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Fargo, ND
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659
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Fayetteville, AR
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Fountain Valley, California 92708
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Fountain Valley, CA
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976
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Hollywood, FL
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166
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Indianapolis, IN
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618
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Kansas City, MO
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La Jolla, CA
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Longview, TX
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Louisville, KY
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Madison, WI
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Marietta, GA
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508
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Memphis, TN
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Minneapolis, MN
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Morgantown, WV
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Nashville, TN
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New Albany, IN
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New Haven, CT
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New York, NY
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Odessa, TX
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Quincy, IL
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San Marcos, TX
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Scottsdale, AZ
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Sherman, TX
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Spokane, WA
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St Louis, MO
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Sugar Land, TX
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Tampa, FL
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The Woodlands, TX
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Thomasville, GA
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Tucson, AZ
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Vancouver, WA
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West Palm Beach, FL
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Westwood, KS
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784
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Wichita, KS
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948
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Wichita Falls, TX
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