Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
NCT ID: NCT00686959
Last Updated: 2016-06-28
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
598 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-09-30
Study Completion Date
2014-11-30
Brief Summary
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This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.
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Detailed Description
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Conditions
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Non Small Cell Lung Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm A: Pemetrexed + Cisplatin and TRT
Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 milligrams per meter squared (mg/m\^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.
Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray \[Gy\] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
Group Type
EXPERIMENTAL
Pemetrexed
Intervention Type
DRUG
infusion over 10 minutes
Cisplatin
Intervention Type
DRUG
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
Thoracic Radiation Therapy (TRT)
Intervention Type
RADIATION
Arm B: Etoposide + Cisplatin and TRT
Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
Group Type
ACTIVE_COMPARATOR
Cisplatin
Intervention Type
DRUG
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
Etoposide
Intervention Type
DRUG
administered per local practice guidelines over a minimum of 30 minutes
Vinorelbine
Intervention Type
DRUG
administered over 6-10 minutes infusion per local practice guidelines
Paclitaxel
Intervention Type
DRUG
administered as a 3-hour infusion
Carboplatin
Intervention Type
DRUG
administered per local practice guidelines over 30 minutes
Thoracic Radiation Therapy (TRT)
Intervention Type
RADIATION
Interventions
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Pemetrexed
infusion over 10 minutes
Intervention Type
DRUG
Cisplatin
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
Intervention Type
DRUG
Etoposide
administered per local practice guidelines over a minimum of 30 minutes
Intervention Type
DRUG
Vinorelbine
administered over 6-10 minutes infusion per local practice guidelines
Intervention Type
DRUG
Paclitaxel
administered as a 3-hour infusion
Intervention Type
DRUG
Carboplatin
administered per local practice guidelines over 30 minutes
Intervention Type
DRUG
Thoracic Radiation Therapy (TRT)
Intervention Type
RADIATION
Other Intervention Names
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Alimta
LY231514
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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New Haven, Connecticut, United States
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Hollywood, Florida, United States
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Athens, Georgia, United States
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Marietta, Georgia, United States
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Thomasville, Georgia, United States
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New Albany, Indiana, United States
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Louisville, Kentucky, United States
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Columbia, Maryland, United States
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Fairhaven, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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The Bronx, New York, United States
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Cincinnati, Ohio, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Longview, Texas, United States
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Odessa, Texas, United States
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San Marcos, Texas, United States
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Sherman, Texas, United States
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Sugar Land, Texas, United States
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The Woodlands, Texas, United States
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Wichita Falls, Texas, United States
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Burlington, Vermont, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
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Buenos Aires, , Argentina
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Wollongong, New South Wales, Australia
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Launceston, Tasmania, Australia
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Frankston, Victoria, Australia
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Antwerp, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Gilly, , Belgium
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Haine-St.- Paul, , Belgium
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Leuven, , Belgium
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Namur, , Belgium
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Turnhout, , Belgium
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Barretos, , Brazil
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Guangzhou, , China
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Jinan, , China
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Shanghai, , China
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Sichuan, , China
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Wuhan, , China
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Bayonne, , France
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Lille, , France
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Paris, , France
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Pierre-Bénite, , France
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Cologne, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Hanover, , Germany
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Hemer, , Germany
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Immenhausen, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Oldenburg, , Germany
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Rheine, , Germany
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Ulm, , Germany
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Athens, , Greece
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Pátrai, , Greece
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Bangalore, , India
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Hyderabaad, , India
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Jaipur, , India
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Kolkata, , India
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Madurai, , India
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Mumbai, , India
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Trivandrum, , India
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Dublin, , Ireland
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Lisbon, , Portugal
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Santa Maria da Feira, , Portugal
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Vila Franca de Xira, , Portugal
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Incheon, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Alicante, , Spain
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Badalona, , Spain
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Elche, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Pamplona, , Spain
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Terrassa, , Spain
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Kaohsiung City, , Taiwan
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Kuei Shan Hsiang, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Fatih, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Melikgazi, , Turkey (Türkiye)
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Umuttepe, , Turkey (Türkiye)
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Edgbaston, Birmingham, United Kingdom
Site Status
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London, Greater London, United Kingdom
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Edinburgh, Scotland, United Kingdom
Site Status
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Manchester, United Kingdom, United Kingdom
Site Status
Countries
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United States
Argentina
Australia
Belgium
Brazil
Canada
China
France
Germany
Greece
India
Ireland
Netherlands
Portugal
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
References
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Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.
Reference Type
DERIVED
Brade AM, Wenz F, Koppe F, Lievens Y, San Antonio B, Iscoe NA, Hossain A, Chouaki N, Senan S. Radiation Therapy Quality Assurance (RTQA) of Concurrent Chemoradiation Therapy for Locally Advanced Non-Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.
Reference Type
DERIVED
Other Identifiers
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H3E-MC-JMIG
Identifier Type: OTHER
Identifier Source: secondary_id
11514
Identifier Type: -
Identifier Source: org_study_id
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