Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00686959




Registration number
NCT00686959
Ethics application status
Date submitted
28/05/2008
Date registered
30/05/2008
Date last updated
28/06/2016

Titles & IDs
Public title
Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
Scientific title
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
Secondary ID [1] 0 0
H3E-MC-JMIG
Secondary ID [2] 0 0
11514
Universal Trial Number (UTN)
Trial acronym
PROCLAIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Vinorelbine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin

Experimental: 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

Active comparator: 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


Treatment: Drugs: Pemetrexed
infusion over 10 minutes

Treatment: Drugs: Cisplatin
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines

Treatment: Drugs: Etoposide
administered per local practice guidelines over a minimum of 30 minutes

Treatment: Drugs: Vinorelbine
administered over 6-10 minutes infusion per local practice guidelines

Treatment: Drugs: Paclitaxel
administered as a 3-hour infusion

Treatment: Drugs: Carboplatin
administered per local practice guidelines over 30 minutes
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Baseline to Date of Death from Any Cause (Up to 71.4 Months)
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
Secondary outcome [2] 0 0
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Timepoint [2] 0 0
Baseline to Measured Progressive Disease (Up to 7 Months)
Secondary outcome [3] 0 0
Survival Rates at 1, 2, and 3 Years
Timepoint [3] 0 0
Baseline to Date of Death from Any Cause (Up to 71.4 Months)
Secondary outcome [4] 0 0
First Site of Disease Failure in Terms of Relapse
Timepoint [4] 0 0
Baseline to Relapse (Up to 66.6 Months)
Secondary outcome [5] 0 0
Percentage of Participants With a Post Baseline Swallowing Diary Score >=4
Timepoint [5] 0 0
Baseline through 30 Days Post Study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
598
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Launceston
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Frankston
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
7250 - Launceston
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Vermont
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
West Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Buenos Aires
Country [28] 0 0
Belgium
State/province [28] 0 0
Antwerp
Country [29] 0 0
Belgium
State/province [29] 0 0
Edegem
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Gilly
Country [32] 0 0
Belgium
State/province [32] 0 0
Haine-St.- Paul
Country [33] 0 0
Belgium
State/province [33] 0 0
Leuven
Country [34] 0 0
Belgium
State/province [34] 0 0
Namur
Country [35] 0 0
Belgium
State/province [35] 0 0
Turnhout
Country [36] 0 0
Brazil
State/province [36] 0 0
Barretos
Country [37] 0 0
Brazil
State/province [37] 0 0
Curitiba
Country [38] 0 0
Brazil
State/province [38] 0 0
Porto Alegre
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio De Janeiro
Country [40] 0 0
Brazil
State/province [40] 0 0
São Paulo
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
China
State/province [44] 0 0
Beijing
Country [45] 0 0
China
State/province [45] 0 0
Guang Zhou
Country [46] 0 0
China
State/province [46] 0 0
Jinan
Country [47] 0 0
China
State/province [47] 0 0
Shanghai
Country [48] 0 0
China
State/province [48] 0 0
Sichuan
Country [49] 0 0
China
State/province [49] 0 0
Wu Han
Country [50] 0 0
France
State/province [50] 0 0
Bayonne
Country [51] 0 0
France
State/province [51] 0 0
Lille
Country [52] 0 0
France
State/province [52] 0 0
Paris
Country [53] 0 0
France
State/province [53] 0 0
Pierre Benite
Country [54] 0 0
Germany
State/province [54] 0 0
Erlangen
Country [55] 0 0
Germany
State/province [55] 0 0
Frankfurt
Country [56] 0 0
Germany
State/province [56] 0 0
Hannover
Country [57] 0 0
Germany
State/province [57] 0 0
Hemer
Country [58] 0 0
Germany
State/province [58] 0 0
Immenhausen
Country [59] 0 0
Germany
State/province [59] 0 0
Köln
Country [60] 0 0
Germany
State/province [60] 0 0
Mainz
Country [61] 0 0
Germany
State/province [61] 0 0
Mannheim
Country [62] 0 0
Germany
State/province [62] 0 0
Oldenburg
Country [63] 0 0
Germany
State/province [63] 0 0
Rheine
Country [64] 0 0
Germany
State/province [64] 0 0
Ulm
Country [65] 0 0
Greece
State/province [65] 0 0
Athens
Country [66] 0 0
Greece
State/province [66] 0 0
Patras
Country [67] 0 0
India
State/province [67] 0 0
Bangalore
Country [68] 0 0
India
State/province [68] 0 0
Hyderabaad
Country [69] 0 0
India
State/province [69] 0 0
Jaipur
Country [70] 0 0
India
State/province [70] 0 0
Kolkata
Country [71] 0 0
India
State/province [71] 0 0
Madurai
Country [72] 0 0
India
State/province [72] 0 0
Mumbai
Country [73] 0 0
India
State/province [73] 0 0
Trivandrum
Country [74] 0 0
Ireland
State/province [74] 0 0
Dublin
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Incheon
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Seoul
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Suwon-City
Country [78] 0 0
Netherlands
State/province [78] 0 0
Amsterdam
Country [79] 0 0
Netherlands
State/province [79] 0 0
Breda
Country [80] 0 0
Netherlands
State/province [80] 0 0
S-Hertogenbosch
Country [81] 0 0
Portugal
State/province [81] 0 0
Lisbon
Country [82] 0 0
Portugal
State/province [82] 0 0
Santa Maria Da Feira
Country [83] 0 0
Portugal
State/province [83] 0 0
Vila Franca De Xira
Country [84] 0 0
Spain
State/province [84] 0 0
Alicante
Country [85] 0 0
Spain
State/province [85] 0 0
Badalona
Country [86] 0 0
Spain
State/province [86] 0 0
Elche
Country [87] 0 0
Spain
State/province [87] 0 0
Hospitalet De Llobregat
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Majadahonda
Country [90] 0 0
Spain
State/province [90] 0 0
Pamplona
Country [91] 0 0
Spain
State/province [91] 0 0
Terrassa
Country [92] 0 0
Taiwan
State/province [92] 0 0
Kaohsiung
Country [93] 0 0
Taiwan
State/province [93] 0 0
Kuei Shan Hsiang
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taichung
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
Turkey
State/province [96] 0 0
Fatih
Country [97] 0 0
Turkey
State/province [97] 0 0
Gaziantep
Country [98] 0 0
Turkey
State/province [98] 0 0
Izmir
Country [99] 0 0
Turkey
State/province [99] 0 0
Melikgazi
Country [100] 0 0
Turkey
State/province [100] 0 0
Umuttepe
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Birmingham
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Greater London
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Scotland
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.
Trial website
https://clinicaltrials.gov/study/NCT00686959
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00686959