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

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pemetrexed

Cisplatin

Etoposide

Vinorelbine

Paclitaxel

Carboplatin

Thoracic Radiation Therapy (TRT)

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Pemetrexed + Cisplatin and TRT

Arm B: Etoposide + Cisplatin and TRT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival

Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.

Secondary Outcome Measures

Progression-free Survival (PFS)

Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.

Objective Response Rate (Complete Response [CR] + Partial Response [PR])

Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

Survival Rates at 1, 2, and 3 Years

The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.

First Site of Disease Failure in Terms of Relapse

The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.

Percentage of Participants With a Post Baseline Swallowing Diary Score >=4

Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.

Full Information

NCT ID

NCT00686959

First Posted

May 28, 2008

Last Updated

May 20, 2016

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00686959

Brief Title

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

Acronym

PROCLAIM

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

598 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Pemetrexed + Cisplatin and TRT

Arm Type

Experimental

Arm Description

Arm Title

Arm B: Etoposide + Cisplatin and TRT

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta, LY231514

Intervention Description

infusion over 10 minutes

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

administered per local practice guidelines over a minimum of 30 minutes

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Intervention Description

administered over 6-10 minutes infusion per local practice guidelines

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

administered as a 3-hour infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

administered per local practice guidelines over 30 minutes

Intervention Type

Radiation

Intervention Name(s)

Thoracic Radiation Therapy (TRT)

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time Frame

Baseline to Date of Death from Any Cause (Up to 71.4 Months)

Secondary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

Time Frame

Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)

Title

Objective Response Rate (Complete Response [CR] + Partial Response [PR])

Description

Time Frame

Baseline to Measured Progressive Disease (Up to 7 Months)

Title

Survival Rates at 1, 2, and 3 Years

Description

The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.

Time Frame

Baseline to Date of Death from Any Cause (Up to 71.4 Months)

Title

First Site of Disease Failure in Terms of Relapse

Description

Time Frame

Baseline to Relapse (Up to 66.6 Months)

Title

Percentage of Participants With a Post Baseline Swallowing Diary Score >=4

Description

Time Frame

Baseline through 30 Days Post Study

Other Pre-specified Outcome Measures:

Title

Adverse Events: The Number of Deaths Per Treatment Group

Description

The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Time Frame

Baseline through 30 Days Post Study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Facility Name

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

City

Thomasville

State/Province

Georgia

ZIP/Postal Code

31792

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40402

Country

United States

Facility Name

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

City

Fairhaven

State/Province

Massachusetts

ZIP/Postal Code

02719

Country

United States

Facility Name

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

City

Longview

State/Province

Texas

ZIP/Postal Code

75601

Country

United States

Facility Name

City

Odessa

State/Province

Texas

ZIP/Postal Code

79761

Country

United States

Facility Name

City

San Marcos

State/Province

Texas

ZIP/Postal Code

78666

Country

United States

Facility Name

City

Sherman

State/Province

Texas

ZIP/Postal Code

75090

Country

United States

Facility Name

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76310

Country

United States

Facility Name

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05405

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99220

Country

United States

Facility Name

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98684

Country

United States

Facility Name

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1188AAF

Country

Argentina

Facility Name

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

City

Launceston

State/Province

Tasmania

ZIP/Postal Code

7250

Country

Australia

Facility Name

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

City

Antwerp

ZIP/Postal Code

2020

Country

Belgium

Facility Name

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

City

Haine-St.- Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

City

Barretos

ZIP/Postal Code

14784700

Country

Brazil

Facility Name

City

Curitiba

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90610-970

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

01246000

Country

Brazil

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y2P9

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

City

Guang Zhou

ZIP/Postal Code

510060

Country

China

Facility Name

City

Jinan

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

City

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

City

Wu Han

ZIP/Postal Code

430030

Country

China

Facility Name

City

Bayonne

ZIP/Postal Code

64100

Country

France

Facility Name

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

City

Hemer

ZIP/Postal Code

58675

Country

Germany

Facility Name

City

Immenhausen

ZIP/Postal Code

34376

Country

Germany

Facility Name

City

Köln

ZIP/Postal Code

51109

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

City

Oldenburg

ZIP/Postal Code

26121

Country

Germany

Facility Name

City

Rheine

ZIP/Postal Code

48431

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

18537

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

City

Bangalore

ZIP/Postal Code

560 027

Country

India

Facility Name

City

Hyderabaad

ZIP/Postal Code

500024

Country

India

Facility Name

City

Jaipur

ZIP/Postal Code

302016

Country

India

Facility Name

City

Kolkata

ZIP/Postal Code

700029

Country

India

Facility Name

City

Madurai

ZIP/Postal Code

625020

Country

India

Facility Name

City

Mumbai

ZIP/Postal Code

400053

Country

India

Facility Name

City

Trivandrum

ZIP/Postal Code

695011

Country

India

Facility Name

City

Dublin

Country

Ireland

Facility Name

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

139-706

Country

Korea, Republic of

Facility Name

City

Suwon-City

ZIP/Postal Code

442-723

Country

Korea, Republic of

Facility Name

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

City

S-Hertogenbosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Facility Name

City

Lisbon

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

City

Santa Maria Da Feira

ZIP/Postal Code

4520-211

Country

Portugal

Facility Name

City

Vila Franca De Xira

ZIP/Postal Code

4434-502

Country

Portugal

Facility Name

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

City

Badalona

ZIP/Postal Code

08915

Country

Spain

Facility Name

City

Elche

ZIP/Postal Code

03202

Country

Spain

Facility Name

City

Hospitalet De Llobregat

ZIP/Postal Code

08908

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

City

Terrassa

ZIP/Postal Code

08227

Country

Spain

Facility Name

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

City

Kuei Shan Hsiang

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

City

Fatih

ZIP/Postal Code

34098

Country

Turkey

Facility Name

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

City

Melikgazi

ZIP/Postal Code

38039

Country

Turkey

Facility Name

City

Umuttepe

ZIP/Postal Code

41380

Country

Turkey

Facility Name

City

Edgbaston

State/Province

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

City

London

State/Province

Greater London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

City

Edinburgh

State/Province

Scotland

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31125266

Citation

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.

Results Reference

derived

PubMed Identifier

29976505

Citation

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.

Results Reference

derived

Learn more about this trial

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

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