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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
Histologically or cytologically documented small cell lung cancer (SCLC)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11.25 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Study 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 below
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My lung cancer diagnosis was confirmed through lab tests.
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My cancer is in one side of my chest and has spread to nearby lymph nodes.
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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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My lung cancer diagnosis was confirmed through lab tests.
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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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I have a tumor that can be measured by scans.
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I have had only one round of chemotherapy that included carboplatin or cisplatin and etoposide.
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I am 18 years old or older.
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I can care for myself and am up and about more than 50% of my waking hours.
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My kidney function, measured by creatinine levels or clearance, is within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11.25 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11.25 years for reporting.

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 more

Awards & Highlights

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.

Trial 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
216,902 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,223,069 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

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00632853 — Phase 3
Lung Cancer Research Study Groups: Arm B - High Dose Radiotherapy + Chemotherapy, Arm A - Standard Radiotherapy + Chemotherapy
Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00632853 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00632853 — Phase 3
Lung Cancer Patient Testimony for trial: Trial Name: NCT00632853 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different places in Canada are running this trial?

"Ochsner Medical Center Jefferson in New Orleans, Louisiana, Memorial Sloan Kettering Nassau in Uniondale, New york, and Cooper Hospital University Medical Center in Camden, New jersey, are all participating in this clinical trial, which is also running at 100 other hospitals."

Answered by AI

What are some risks associated with High Radiation Dose Therapy?

"High Radiation Dose Therapy received a 3 because there is both evidence of efficacy and multiple rounds of data affirming its safety."

Answered by AI

How does High Radiation Dose Therapy compare to other treatments?

"There are presently 1323 ongoing clinical trials for High Radiation Dose Therapy, with the majority of these being in Phase 3. The 427 trials for High Radiation Dose Therapy are primarily located in Shanghai, but there are 70884 locations running clinical trials for High Radiation Dose Therapy globally."

Answered by AI

How is High Radiation Dose Therapy most often used?

"While most commonly used to treat advanced non small cell lung cancer, High Radiation Dose Therapy has also shown efficacy against other conditions such as recurrent, advance directives, and advanced cervical cancer."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
21st Century Oncology - Fort Walton Beach
Dana-Farber/Brigham and Women's Cancer Center at South Shore
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I’m one and half years out from treatment and remain in remission. Knowing SCLC is a difficult diagnosis I want to be sure to know all my options should I have a reoccurrence.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When will I know if I can have a screening?
PatientReceived 2+ prior treatments
~43 spots leftby Feb 2025