Combined Chemoradiotherapy for Non-Small Cell Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Gemcitabine

Disqualifiers: Previous chest radiation, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for non-small cell lung cancer (NSCLC) that cannot be surgically removed. It combines specialized radiation therapies, including hypofractionated radiation therapy and stereotactic body radiation therapy (also known as stereotactic ablative radiotherapy or CyberKnife), with chemotherapy drugs carboplatin and paclitaxel. This approach aims to target and kill more cancer cells while protecting healthy tissue. The researchers aim to determine if this combination is more effective in treating the cancer. Individuals with stage II-III NSCLC who cannot undergo surgery might be suitable candidates. As an unphased trial, this study allows patients to contribute to groundbreaking research that could lead to new treatment options.

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

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot use gemcitabine-based chemotherapy during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the chemotherapy drugs carboplatin and paclitaxel are well-studied and known to be safe. When combined, they are generally well-tolerated by patients with non-small cell lung cancer (NSCLC). Common side effects include low blood cell counts and fatigue, but these are usually manageable.

Hypofractionated radiation therapy (HFRT) has also undergone safety testing. This method uses fewer but larger doses of radiation. Research suggests that HFRT is safe and effective for treating lung cancer, targeting the cancer more precisely and potentially protecting nearby healthy tissue.

Overall, both the chemotherapy and radiation treatments in this trial have been tested in previous studies with promising safety results. Participants should still consult their healthcare provider about possible side effects before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment for non-small cell lung cancer because it combines stereotactic body radiation therapy (SBRT) with carboplatin and paclitaxel. Unlike standard treatments that often take longer, this approach uses image-guided hypofractionated radiation, which precisely targets the tumor over a shorter period, potentially enhancing effectiveness while minimizing side effects. This innovative radiation technique could allow for more aggressive targeting of cancer cells, with the possibility of improved patient outcomes.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that using carboplatin and paclitaxel together can help treat non-small cell lung cancer (NSCLC). Studies have found that this combination can lead to a one-year survival rate of up to 54%. In this trial, participants will receive this combination alongside hypofractionated radiation therapy, which involves delivering larger doses of radiation in fewer sessions. This type of radiation targets the tumor while minimizing harm to normal tissue, making it a suitable option for inoperable NSCLC. Combining these treatments in this trial might enhance their effectiveness and improve patient outcomes. ^{5 6 7 8 9}

Who Is on the Research Team?

Percy Lee

Principal Investigator

Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with stage II-III non-small cell lung cancer that can't be surgically removed. They must have a Karnofsky performance status of at least 70, meaning they are able to care for themselves. Pregnant women or those not using contraception are excluded, as well as patients who've had chest radiation before or refuse consent.

Inclusion Criteria

I have stage II lung cancer and cannot or will not undergo surgery as advised by a thoracic surgeon.

I am able to care for myself but may not be able to do active work.

My lung cancer is confirmed and has not spread beyond my lungs.

Exclusion Criteria

You are receiving treatment for another medical condition at the same time.

I am not pregnant and willing to use contraception during and 4 weeks after the study.

I am currently receiving gemcitabine-based chemotherapy along with radiotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost

2 weeks

Chemotherapy

Patients receive standard carboplatin and paclitaxel for 3 weeks

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks initially, then every 3 months for 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin, Paclitaxel
• Hypofractionated Radiation Therapy
• Stereotactic Body Radiation Therapy

Trial Overview The study tests if combining image-guided hypofractionated RT (a type of targeted radiation therapy) with a boost and chemotherapy drugs carboplatin and paclitaxel is more effective in killing tumor cells while sparing normal tissue compared to standard treatments.

How Is the Trial Designed?

Group I: Treatment (dose-escalation of RT) Experimental Treatment 6 Interventions

Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

In a study of 70 patients with inoperable non-small cell lung cancer (NSCLC), carboplatin alone showed a 16% overall response rate with an acceptable safety profile, indicating its potential as a treatment option.

Combination therapies involving carboplatin with other drugs like etoposide and vinblastine yielded response rates of 11%, 12%, and 20%, respectively, but with increased toxicity, particularly myelosuppression, highlighting the need to balance efficacy and safety in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin in non-small cell lung cancer: an update on the Cancer and Leukemia Group B experience. Green, MR., Kreisman, H., Doll, DC., et al.[2018]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

In a study of 89 patients with advanced nonsmall cell lung cancer, both carboplatin plus paclitaxel and gemcitabine plus vinorelbine showed similar 1-year survival rates below 30%, indicating limited efficacy for both treatment regimens.

Both treatment combinations resulted in significant toxicities, with carboplatin plus paclitaxel causing more nausea and gemcitabine plus vinorelbine leading to higher rates of anemia and treatment-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase II study of carboplatin-paclitaxel or gemcitabine-vinorelbine in patients with advanced nonsmall cell lung cancer and a performance status of 2: West Japan Thoracic Oncology Group 0004. Saito, H., Nakagawa, K., Takeda, K., et al.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

The combination of paclitaxel and carboplatin followed by thoracic radiation therapy (TRT) has shown promising efficacy in treating locally advanced non-small-cell lung cancer (NSCLC), with a 60% partial response rate to combined therapy and a median survival of 15.3 months for all patients.

The treatment was well-tolerated, with manageable side effects, and the chemotherapy doses were safely escalated, indicating that this approach can be an effective option for patients with locally advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction and concurrent paclitaxel/carboplatin every 3 weeks with thoracic radiotherapy in locally advanced non-small-cell lung cancer: an interim report. Movsas, B., Hudes, RS., Schol, J., et al.[2019]

Stereotactic ablative radiotherapy (SABR) shows high local control rates of 97.3% at 1 year and 95.7% at 2 years for treating inoperable early-stage small cell lung cancer, based on a meta-analysis of 399 patients across seven studies.

The treatment demonstrates limited toxicity, with only 12.6% of patients experiencing grade 1 toxicity and no severe grade 4 or 5 events reported, indicating that SABR is a safe option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy in T1-2N0M0 small cell lung cancer: A systematic review and meta-analysis. Safavi, AH., Mak, DY., Boldt, RG., et al.[2022]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is the standard treatment for early-stage non-small-cell lung cancer that cannot be surgically removed, showing high rates of tumor control but facing challenges with regional and distant tumor failures.

Current research is exploring the use of immune checkpoint inhibitors as a systemic therapy option for patients treated with SABR, aiming to provide effective treatment with fewer side effects compared to traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inoperable Early-Stage Non-Small-Cell Lung Cancer: Stereotactic Ablative Radiotherapy and Rationale for Systemic Therapy. Daly, ME.[2022]

Citations

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Efficacy Comparison Between Weekly and Triweekly ... We demonstrated that weekly CP treatment, which is known to have fewer toxicity in NSCLC, provided better PFS compared to triweekly treatment.

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The efficacy and safety of paclitaxel and carboplatin with ... Our meta-analysis demonstrated that Bev significantly prolonged the PFS, OS and RR when combined with PC as first-line therapy in patients with non-squamous ...

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Paclitaxel–Carboplatin Alone or with Bevacizumab for Non ... Results. The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab, as compared with 10.3 months in the chemotherapy-alone ...

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Carboplatin, Weekly Paclitaxel and Pembrolizumab in ... Brief Report: Carboplatin, Weekly Paclitaxel and Pembrolizumab in Elderly Patients for Advanced Non-Small Cell Lung Cancer With PD-L1 < 50%: Real-World Data.

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Real-world safety of carboplatin in non-small cell lung cancer The most reliable method to investigate carboplatin's intrinsic safety profile would be to analyze data from cases where carboplatin was ...

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The combination of carboplatin and weekly paclitaxel The median time to progression was 8.0 mos (range: 7.0-19.0) and the median survival was 14.0 months (range: 9.0-19.0). The association of carboplatin AUC = 6 ...

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Efficacy and safety analysis according to histology for S-1 ... Median OS was 14.0 months in the carboplatin–S-1 arm and 10.6 months in the carboplatin–paclitaxel arm (HR 0.713; 95% CI 0.476–1.068) for patients with squamous ...