Whole-Brain Radiation Therapy for Small Cell Lung Cancer

Recruiting at 298 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: NRG Oncology

Disqualifiers: CNS metastases, Hydrocephalus, Invasive malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

418 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, planned concurrent chemotherapy during the trial is not allowed, except for atezolizumab, which is permitted.

What data supports the effectiveness of the treatment Hippocampal Avoidance, Whole-Brain Radiation Therapy for small cell lung cancer?

Whole-brain radiation therapy (WBRT) is effective in improving symptoms for most patients with brain metastases from small cell lung cancer, and it is considered a standard treatment. However, the specific effectiveness of hippocampal avoidance in this context is not directly addressed in the available research. ^{1 2 3 4 5}

Is whole-brain radiation therapy generally safe for humans?

Whole-brain radiation therapy (WBRT) can cause neurocognitive toxicity (damage to brain function), which may affect quality of life. Strategies like hippocampal avoidance techniques are being studied to reduce these side effects. Some patients may experience neurologic dysfunction, but the exact contribution of radiation versus other treatments is unclear. ^{4 6 7 8 9}

How does whole-brain radiation therapy differ from other treatments for small cell lung cancer?

Whole-brain radiation therapy (WBRT) is unique because it targets the entire brain to manage or prevent brain metastases (spread of cancer to the brain) in small cell lung cancer patients. Unlike systemic chemotherapy, which treats cancer throughout the body, WBRT focuses specifically on the brain and is often used when brain metastases are present or as a preventive measure. ^{2 4 6 9 10}

Research Team

Vinai Gondi

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with small cell lung cancer who've responded to chemotherapy, can undergo MRI scans, and agree to use contraception. It's not for those with prior head/neck radiation (except T1 glottic cancer), CNS metastases, severe comorbidities, other recent cancers (except skin cancer), or untreated HIV.

Inclusion Criteria

I finished my chemotherapy between 1 to 8 weeks ago.

I have extensive-stage small cell lung cancer and may get chest radiation after chemotherapy.

My small cell lung cancer is classified as either limited or extensive stage.

Exclusion Criteria

You cannot have a magnetic resonance imaging (MRI) scan if you have metal implants or severe claustrophobia.

I have had radiotherapy to my head or neck, excluding T1 glottic cancer, with overlapping radiation fields.

I will receive chemotherapy or cancer drugs during my brain radiation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo prophylactic cranial irradiation (PCI) with or without hippocampal avoidance for 2 weeks, 5 fractions per week

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups every 3 months for 1 year, then every 6 months until 3 years, and annually thereafter

3 years

Treatment Details

Interventions

• Hippocampal Avoidance
• Whole-Brain Radiation Therapy

Trial Overview The study compares whole-brain radiation therapy effectiveness with and without avoiding the hippocampus—a brain area linked to memory—to see if it reduces cognitive side effects while treating lung cancer that is limited stage or has spread extensively.

Participant Groups

Group I: PCI with HA using IMRT Experimental Treatment 1 Intervention

PCI with hippocampal avoidance (HA) using intensity-modulated radiation therapy (IMRT) for 2 weeks, 5 fractions/week.

Group II: PCI using 3DCRT Active Control 1 Intervention

Prophylactic cranial irradiation (PCI) using three-dimensional conformal radiation therapy (3DCRT) for 2 weeks, 5 fractions/week.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Radiation Therapy Oncology Group

Collaborator

Trials

191

Recruited

64,900+

References

1. United States pubmed.ncbi.nlm.nih.gov

Brain Metastases From Small Cell Lung Cancer: Chemotherapy, Radiotherapy, or Both? [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Outcome and prognostic factors in single brain metastases from small-cell lung cancer. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of brain metastases of small-cell lung cancer: comparing teniposide and teniposide with whole-brain radiotherapy--a phase III study of the European Organization for the Research and Treatment of Cancer Lung Cancer Cooperative Group. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Current concepts in the management of small cell carcinoma of the lung. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Risk stratification of symptomatic brain metastases by clinical and FDG PET parameters for selective use of prophylactic cranial irradiation in patients with extensive disease of small cell lung cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Time Interval to Initiation of Whole-Brain Radiation Therapy in Patients With Small Cell Lung Cancer With Brain Metastasis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Neurologic dysfunction in patients treated for small cell carcinoma of the lung: a clinical and radiological study. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Prophylactic cranial irradiation (PCI), hippocampal avoidance (HA) whole brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) in small cell lung cancer (SCLC): Where do we stand? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

An update on the treatment of CNS metastases in small cell lung cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery for Brain Metastases in Patients With Small Cell Lung Cancer. [2023]