← Back to Search

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Select...

I am 18 years old or older.

Select...

My cancer is confined to one side of my chest and has spread only to nearby lymph nodes.

Select...

My lung cancer diagnosis was confirmed through lab tests.

Select...

I have a tumor that can be measured by scans.

Select...

My kidney function, measured by creatinine levels or clearance, is within the required range.

Select...

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.

Select...

I have not had surgery to completely remove my cancer.

Select...

I do not have fluid in my lungs or, if I do, it has been tested and is not cancerous.

Select...

My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.

Select...

I have not had radiation therapy to my chest area.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 11.25 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival Time

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