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Alkylating agents
Radiation + Chemotherapy for Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age Requirement ≥ 18 years of age
Limited-stage disease patients with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
Must not have
No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC
Patients with complete surgical resection of disease are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11.25 years
Awards & highlights
Summary
This trial is testing different radiation therapy regimens to see which is more effective in treating patients with limited-stage small cell lung cancer when given together with chemotherapy.
Who is the study for?
This trial is for adults with limited-stage small cell lung cancer, who have measurable disease and haven't had complete surgical resection or prior chest radiotherapy. They can have received one cycle of specific chemotherapy. Key health metrics like blood counts and liver/kidney function must be within certain limits.Check my eligibility
What is being tested?
The study compares different doses of radiation therapy combined with chemotherapy drugs (cisplatin, etoposide, carboplatin) to see which regimen is more effective against limited-stage small cell lung cancer. It's a phase III trial where patients are randomly assigned to treatment groups.See study design
What are the potential side effects?
Radiation may cause fatigue, skin reactions at the treatment site, and difficulty swallowing. Chemotherapy can lead to nausea, hair loss, low blood counts increasing infection risk, kidney issues from cisplatin, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is confined to one side of my chest and has spread only to nearby lymph nodes.
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My lung cancer diagnosis was confirmed through lab tests.
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I have a tumor that can be measured by scans.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I can care for myself and am up and about more than 50% of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemo or radiation for small cell lung cancer, except as noted before.
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I have not had surgery to completely remove my cancer.
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I do not have fluid in my lungs or, if I do, it has been tested and is not cancerous.
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My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.
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I have not had radiation therapy to my chest area.
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I do not have cancer cells in my chest or heart fluid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 11.25 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11.25 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival Time
Secondary outcome measures
Complete and Partial Response Rates
Failure-free >> Survival
To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State.
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B - High Dose Radiotherapy + ChemotherapyExperimental Treatment4 Interventions
Radiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks
Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):
Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days
Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Group II: Arm A - Standard Radiotherapy + ChemotherapyActive Control4 Interventions
Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks
Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):
Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days
Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cisplatin
1997
Completed Phase 3
~3290
etoposide
1994
Completed Phase 3
~9300
carboplatin
2010
Completed Phase 3
~4790
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,895 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,670 Total Patients Enrolled
Jeffrey A. Bogart, MDStudy ChairState University of New York - Upstate Medical University
1 Previous Clinical Trials
544 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confined to one side of my chest and has spread only to nearby lymph nodes.I have had only one round of chemotherapy that included carboplatin or cisplatin and etoposide.I have not had surgery to completely remove my cancer.My lung cancer diagnosis was confirmed through lab tests.I have a tumor that can be measured by scans.I do not have fluid in my lungs or, if I do, it has been tested and is not cancerous.I haven't had chemo or radiation for small cell lung cancer, except as noted before.I am 18 years old or older.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.You have a certain type of white blood cells called granulocytes, and you need to have at least 1,500 of them in a tiny drop of blood.Your AST (SGOT) level is not more than 2 times the upper limit of normal.Your blood platelet count is at least 100,000 per microliter.I have not had radiation therapy to my chest area.I do not have cancer cells in my chest or heart fluid.I can care for myself and am up and about more than 50% of my waking hours.Your total bilirubin level is not more than 1.5 times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - Standard Radiotherapy + Chemotherapy
- Group 2: Arm B - High Dose Radiotherapy + Chemotherapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lung Cancer Patient Testimony for trial: Trial Name: NCT00632853 — Phase 3
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