Radiation + Chemotherapy for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+933 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

Research Team

Jeffrey A. Bogart, MD

Principal Investigator

State University of New York - Upstate Medical University

Eligibility Criteria

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.

Inclusion 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.

My lung cancer diagnosis was confirmed through lab tests.

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Exclusion Criteria

I have not had surgery to completely remove my cancer.

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.

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Treatment Details

Interventions

Carboplatin (Alkylating agents)
Cisplatin (Alkylating agents)
Etoposide (Topoisomerase II inhibitors)
High Radiation Dose Therapy (Radiation)
Standard Radiation Dose Therapy (Radiation)

Trial OverviewThe 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.

Participant Groups

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

Carboplatin is already approved in Canada for the following indications: