NCT00686959 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2016-06-28

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

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

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outcome · POSTED

Adverse Events: The Number of Deaths Per Treatment Group

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outcome · POSTED

Survival Rates at 1, 2, and 3 Years

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outcome · POSTED

First Site of Disease Failure in Terms of Relapse

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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
intervention Names
Drug: Pemetrexed
Drug: Cisplatin
Radiation: Thoracic Radiation Therapy (TRT)
label
Arm A: Pemetrexed + Cisplatin and TRT
type
EXPERIMENTAL
description
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
intervention Names
Drug: Cisplatin
Drug: Etoposide
Drug: Vinorelbine
Drug: Paclitaxel
Drug: Carboplatin
Radiation: Thoracic Radiation Therapy (TRT)
label
Arm B: Etoposide + Cisplatin and TRT
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Arm A: Pemetrexed + Cisplatin and TRT
description
infusion over 10 minutes
name
Pemetrexed
other Names
Alimta
LY231514
type
DRUG
arm Group Labels
Arm A: Pemetrexed + Cisplatin and TRT
Arm B: Etoposide + Cisplatin and TRT
description
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
name
Cisplatin
type
DRUG
arm Group Labels
Arm B: Etoposide + Cisplatin and TRT
description
administered per local practice guidelines over a minimum of 30 minutes
name
Etoposide
type
DRUG
arm Group Labels
Arm B: Etoposide + Cisplatin and TRT
description
administered over 6-10 minutes infusion per local practice guidelines
name
Vinorelbine
type
DRUG
arm Group Labels
Arm B: Etoposide + Cisplatin and TRT
description
administered as a 3-hour infusion
name
Paclitaxel
type
DRUG
arm Group Labels
Arm B: Etoposide + Cisplatin and TRT
description
administered per local practice guidelines over 30 minutes
name
Carboplatin
type
DRUG
arm Group Labels
Arm A: Pemetrexed + Cisplatin and TRT
Arm B: Etoposide + Cisplatin and TRT
name
Thoracic Radiation Therapy (TRT)
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 598
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

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.
measure
Adverse Events: The Number of Deaths Per Treatment Group
time Frame
Baseline through 30 Days Post Study

primary Outcomes

description
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.
measure
Overall Survival
time Frame
Baseline to Date of Death from Any Cause (Up to 71.4 Months)

secondary Outcomes

description
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.
measure
Progression-free Survival (PFS)
time Frame
Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
description
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.
measure
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
time Frame
Baseline to Measured Progressive Disease (Up to 7 Months)
description
The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.
measure
Survival Rates at 1, 2, and 3 Years
time Frame
Baseline to Date of Death from Any Cause (Up to 71.4 Months)
description
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.
measure
First Site of Disease Failure in Terms of Relapse
time Frame
Baseline to Relapse (Up to 66.6 Months)
description
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.
measure
Percentage of Participants With a Post Baseline Swallowing Diary Score >=4
time Frame
Baseline through 30 Days Post Study

Full 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.

Source references

references

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.
pmid
31125266
type
DERIVED
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.
pmid
29976505
type
DERIVED