Radiation + Chemotherapy for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests which combination of radiation and chemotherapy best treats limited-stage small cell lung cancer. Researchers compare two different radiation schedules, both paired with chemotherapy drugs: etoposide, carboplatin, or cisplatin. Suitable candidates for this trial have small cell lung cancer limited to one side of the chest and have not yet received radiation or extensive chemotherapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not have had prior radiotherapy or chemotherapy for small cell lung cancer, except for one cycle of specific chemotherapy drugs.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments studied in this trial have been used before and are generally well-tolerated. Here's a breakdown:
1. **High Radiation Dose Therapy**: Studies indicate that higher doses of radiation, like those tested, are usually well-tolerated by patients with small cell lung cancer. Some research suggests that high-dose radiation can improve outcomes for these patients. However, side effects such as tiredness or skin irritation can occur with any radiation treatment.
2. **Cisplatin and Carboplatin**: These common chemotherapy drugs have similar safety profiles and are often used to treat various cancers, including lung cancer. Patients may experience side effects like nausea or low blood cell counts, but these are expected and usually manageable.
3. **Etoposide**: Often used with the other chemotherapy drugs mentioned, etoposide is known to slow tumor growth. While it can cause side effects like hair loss or low blood counts, most patients tolerate it well.
In summary, the treatments in this trial have been used in other settings and are generally considered safe, though they may have side effects typical of cancer treatments. Always discuss any concerns with a healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for small cell lung cancer because they explore different radiation dose intensities combined with chemotherapy. Arm A combines standard-dose radiation with chemotherapy, which is a tried-and-true approach, while Arm B takes it up a notch with high-dose radiation over a longer period. This higher radiation dose could potentially improve the effectiveness of the treatment by delivering more radiation to the tumor, possibly shrinking it more effectively. By comparing these two approaches, researchers hope to discover whether the increased radiation dosage in Arm B offers a significant advantage in controlling the disease.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
In this trial, participants will receive different combinations of treatments to evaluate their effectiveness in treating small cell lung cancer. Research has shown that chemotherapy drugs like cisplatin or carboplatin, when used with etoposide, can extend patient survival. In Arm A of this trial, participants will receive standard radiotherapy combined with chemotherapy, which includes either cisplatin or carboplatin with etoposide. Cisplatin is often recommended because it has improved overall survival, while carboplatin is also effective, with studies showing high success rates when used with etoposide. Etoposide alone has yielded good results, with many patients responding well to it. In Arm B, participants will receive high-dose radiotherapy combined with the same chemotherapy regimen. Higher doses of radiation therapy have not always improved survival compared to standard doses, but both are generally effective in treating small cell lung cancer. Overall, combining these treatments has been shown to fight cancer cells and improve patient outcomes.56789
Who Is on the Research Team?
Jeffrey A. Bogart, MD
Principal Investigator
State University of New York - Upstate Medical University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive thoracic radiotherapy and chemotherapy. Radiotherapy is administered either as standard-dose (45 Gy over 3 weeks), higher-dose (70 Gy over 7 weeks), or mid-dose (61.2 Gy over 5 weeks). Chemotherapy with cisplatin or carboplatin and etoposide is given every 21 days for 4 cycles.
Prophylactic Cranial Irradiotherapy (PCI)
Within 3-6 weeks after completion of chemotherapy, PCI is offered to patients with a complete or near complete tumor response.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years or until disease progression.
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Etoposide
- High Radiation Dose Therapy
- Standard Radiation Dose Therapy
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator