Chemotherapy + High-Dose Radiation for Lung Cancer

Overseen By Sherice Simpson, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: State University of New York - Upstate Medical University

Disqualifiers: Node positive, Metastatic disease, Active malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The standard treatment for patients with Non-Small Cell Lung Cancer (NSCLC) and clinically negative lymph nodes remains surgery per current guidelines. Five year survival for patients with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of these patients have heart and lung issues or other diseases which keep them from undergoing curative surgery. Studies have shown that majority of these patients die from their cancer and not from their other diseases. This is the reason for treating early stage lung cancer patients with definitive therapy, when they cannot have surgery. This study will enroll twelve subjects to evaluate the side effects of this treatment, and decide if it is a good option for the patients that cannot have surgery.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment involving chemotherapy and high-dose radiation for lung cancer?

Research shows that combining chemotherapy drugs like paclitaxel and carboplatin with radiation therapy can improve the control of lung cancer by making the cancer cells more sensitive to radiation, potentially increasing survival rates. ^{1 2 3 4 5}

Is the combination of chemotherapy and high-dose radiation therapy safe for lung cancer patients?

The combination of chemotherapy drugs like paclitaxel and carboplatin with radiation therapy has been studied in lung cancer patients and is generally considered to have acceptable safety, though some patients may experience side effects like esophagitis (inflammation of the esophagus) and neutropenia (low white blood cell count). ^{1 2 4 6 7}

What makes the chemotherapy and high-dose radiation treatment for lung cancer unique?

This treatment combines chemotherapy drugs paclitaxel and carboplatin with high-dose radiation, which may enhance the effect of radiation on tumors and improve local and systemic control of lung cancer compared to standard treatments. It offers a potentially more effective approach by attacking the cancer both locally and throughout the body. ^{2 5 8 9 10}

Research Team

Michael D. Mix

Principal Investigator

State University of New York - Upstate Medical University

Eligibility Criteria

This trial is for patients with a type of lung cancer called NSCLC who can't have surgery due to other health issues or personal choice. They should be relatively active (ECOG 0-2), may have had surgery over a year ago, and any previous radiation or chemo must also be more than a year old. The cancer should not have spread to lymph nodes or elsewhere, and the tumor size needs to fit specific criteria.

Inclusion Criteria

My cancer is in an early stage and the tumor is 2-7cm big.

I cannot undergo lung cancer surgery due to health issues or personal choice.

I had radiation over a year ago, with no cancer growth, and the current issue is in a different lung lobe.

Exclusion Criteria

I cannot undergo standard chemotherapy or radiation as per the study's guidelines.

I do not have another cancer with a high risk of returning, except for certain skin, cervical, or low-risk prostate cancers.

My cancer has spread to lymph nodes or other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive concurrent chemotherapy and hypofractionated radiation therapy. Chemotherapy includes Carboplatin AUC 2 and Paclitaxel 50 mg/m2 given weekly for 4 weeks, concurrently with radiation therapy (70 Gy in 20 fractions) over 4 weeks.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on toxicity as measured using the National Cancer Institute's Common Terminology Criteria for Adverse Events.

24 months

Treatment Details

Interventions

• Carboplatin
• HFR Radiation Therapy
• Paclitaxel

Trial Overview The study tests if high-dose radiation therapy given in fewer treatments (70 Gy in 20 fractions over 4 weeks) combined with chemotherapy drugs Carboplatin and Paclitaxel is effective for NSCLC patients who cannot undergo surgery. It aims to evaluate side effects and potential as a definitive treatment.

Participant Groups

Group I: Chemotherapy with hypofractionated RT Experimental Treatment 3 Interventions

Carboplatin AUC 2 + Paclitaxel 50 mg/m2 given weekly x 4 concurrently with radiation therapy (70 Gy in 20 fractions) over 4 weeks

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

State University of New York - Upstate Medical University

Lead Sponsor

Trials

176

Recruited

27,600+

Findings from Research

In a phase II study involving 56 patients with early-stage non-small-cell lung cancer, concurrent hyperfractionated radiotherapy and low-dose carboplatin/paclitaxel treatment resulted in a 52% complete response rate and a median survival time of 35 months.

The treatment was found to be feasible with manageable toxicity, showing low rates of severe side effects (22% hematologic toxicity) and no grade 5 toxicity, indicating it could be a safe option for patients with this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent hyperfractionated radiotherapy and low-dose daily carboplatin/paclitaxel in patients with early-stage (I/II) non-small-cell lung cancer: long-term results of a phase II study. Jeremić, B., Milicić, B., Acimović, L., et al.[2018]

Combination therapy using paclitaxel with carboplatin and radiation shows promise as a safer and more effective treatment for non-small cell lung cancer compared to the standard regimen of etoposide and cisplatin.

The use of paclitaxel, a novel taxane drug, in conjunction with radiation therapy may enhance local control of the cancer and improve overall response rates, suggesting a potential advancement in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent paclitaxel, carboplatin, and radiation therapy for locally advanced non-small cell lung cancer. Choy, H., Akerley, W., DeVore, RF.[2015]

In a study of 15 patients with inoperable locally advanced non-small cell lung cancer (NSCLC), the combination of paclitaxel, carboplatin, and concurrent radiation therapy resulted in a high overall response rate of 73%, with 13% achieving a complete response and 60% a partial response.

The treatment was associated with manageable toxicity, primarily grade 2 esophagitis in 40% of patients and varying degrees of leukopenia, indicating that while effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A phase I clinical trial of combination chemotherapy of paclitaxel with carboplatin and concurrent radiation therapy in locally advanced non-small cell lung cancer]. Zhu, Y., Zhang, H., Hu, F.[2010]

In a phase II study involving 43 patients with locally advanced unresectable non-small cell lung cancer, the combination of weekly paclitaxel and carboplatin with hyperfractionated radiation therapy resulted in a high overall response rate of 78.6%, with 7.2% achieving a complete response.

The treatment was generally well-tolerated, although esophagitis was a significant side effect, affecting 26% of patients with grade 3 or 4 toxicity, indicating that while effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). Choy, H., Devore, RF., Hande, KR., et al.[2019]

In a Phase I/II trial involving 17 patients with Stage III nonsmall cell lung cancer (NSCLC), the combination of paclitaxel and radiation therapy (60 Gy over 6 weeks) was found to be safe, with a recommended dose of 120 mg/m2 leading to a high response rate of 78%.

The main side effect observed was neutropenia, particularly at the highest dose, but there were no serious infections related to the treatment, indicating that while the combination is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/II study of paclitaxel (TAXOL) and concurrent radiotherapy in advanced nonsmall cell lung cancer. Kirkbride, P., Gelmon, K., Eisenhauer, E., et al.[2019]

In a phase I clinical trial involving 33 patients with non-small cell lung cancer, the maximum tolerated dose of weekly paclitaxel was determined to be 60 mg/m2, combined with radiation therapy, resulting in an impressive overall response rate of 84%.

The treatment was generally well-tolerated, with the most significant side effect being esophagitis, affecting 20% of patients, while only 8% experienced severe neutropenia, indicating a favorable safety profile for this combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary analysis of a phase II study of weekly paclitaxel and concurrent radiation therapy for locally advanced non-small cell lung cancer. Choy, H., Safran, H.[2015]

In a study of 64 patients with stage III non-small-cell lung cancer, the combination of hyperfractionated radiation therapy and low-dose chemotherapy resulted in an impressive objective response rate of 83%, with 42% achieving complete response.

The treatment led to a median survival time of 28 months, with 3- and 5-year survival rates of 37% and 26%, respectively, indicating significant efficacy, although some patients experienced acute high-grade toxicities, particularly hematologic and esophageal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent hyperfractionated radiotherapy and low-dose daily carboplatin and paclitaxel in patients with stage III non-small-cell lung cancer: long-term results of a phase II study. Jeremic, B., Milicic, B., Acimovic, L., et al.[2018]

A systematic review of 31 studies involving 3090 patients treated with cisplatin-etoposide and 48 studies with 3728 patients treated with carboplatin-paclitaxel showed that both chemotherapy regimens had similar efficacy in treating unresectable stage III non-small-cell lung cancer, with no significant differences in overall survival or progression-free survival.

However, carboplatin-paclitaxel was associated with fewer severe hematological toxic effects compared to cisplatin-etoposide, making it a safer option for patients undergoing concurrent thoracic radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Concurrent Use of Thoracic Radiation With Either Carboplatin-Paclitaxel or Cisplatin-Etoposide for Patients With Stage III Non-Small-Cell Lung Cancer: A Systematic Review. Steuer, CE., Behera, M., Ernani, V., et al.[2022]

Induction chemotherapy with paclitaxel and carboplatin, followed by concurrent chemoradiation, showed a 55% response rate and a 1-year survival rate of 72% in patients with locally advanced non-small cell lung cancer, indicating promising efficacy.

The treatment regimen was well-tolerated, with mild myelotoxicity as the primary side effect from induction therapy and limited nonhematologic toxicity during concurrent therapy, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent chemoradiation using paclitaxel and carboplatin in locally advanced non-small cell lung cancer. Langer, CJ.[2015]

Combined chemotherapy with paclitaxel and carboplatin alongside thoracic radiation therapy has shown a clear survival benefit for patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), as demonstrated in randomized trials and meta-analyses.

Ongoing and planned multicenter studies aim to refine treatment regimens and improve both local and systemic control of NSCLC, highlighting the need for a multidisciplinary approach to effectively manage this systemic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporation of paclitaxel and carboplatin in combined-modality therapy for locally advanced non-small cell lung cancer. Belani, CP.[2015]

References

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

Concurrent hyperfractionated radiotherapy and low-dose daily carboplatin/paclitaxel in patients with early-stage (I/II) non-small-cell lung cancer: long-term results of a phase II study. [2018]

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

Concurrent paclitaxel, carboplatin, and radiation therapy for locally advanced non-small cell lung cancer. [2015]

3. China pubmed.ncbi.nlm.nih.gov

[A phase I clinical trial of combination chemotherapy of paclitaxel with carboplatin and concurrent radiation therapy in locally advanced non-small cell lung cancer]. [2010]

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

A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). [2019]

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

A phase I/II study of paclitaxel (TAXOL) and concurrent radiotherapy in advanced nonsmall cell lung cancer. [2019]

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

Preliminary analysis of a phase II study of weekly paclitaxel and concurrent radiation therapy for locally advanced non-small cell lung cancer. [2015]

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

Concurrent hyperfractionated radiotherapy and low-dose daily carboplatin and paclitaxel in patients with stage III non-small-cell lung cancer: long-term results of a phase II study. [2018]

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

Comparison of Concurrent Use of Thoracic Radiation With Either Carboplatin-Paclitaxel or Cisplatin-Etoposide for Patients With Stage III Non-Small-Cell Lung Cancer: A Systematic Review. [2022]

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

Concurrent chemoradiation using paclitaxel and carboplatin in locally advanced non-small cell lung cancer. [2015]

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

Incorporation of paclitaxel and carboplatin in combined-modality therapy for locally advanced non-small cell lung cancer. [2015]