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

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RT together with combination chemotherapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started

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.

What data supports the effectiveness of the treatment for non-small cell lung cancer?

Research shows that stereotactic ablative radiotherapy (SABR), especially using the CyberKnife system, is effective for early-stage non-small cell lung cancer, providing high rates of local tumor control with manageable side effects and a shorter treatment duration. ^{1 2 3 4 5}

Is combined chemoradiotherapy with carboplatin and paclitaxel safe for humans?

Studies show that the combination of carboplatin and paclitaxel, often used with radiation therapy, is generally well-tolerated in patients with non-small cell lung cancer. Some side effects like esophagitis (inflammation of the esophagus) and myelosuppression (decreased bone marrow activity) have been noted, but the treatment is considered safe for many patients. ^{6 7 8 9 10}

How is the treatment of combined chemoradiotherapy with Carboplatin, Paclitaxel, and CyberKnife SABR unique for non-small cell lung cancer?

This treatment is unique because it combines chemotherapy drugs Carboplatin and Paclitaxel with CyberKnife stereotactic ablative radiotherapy (SABR), which precisely targets lung tumors with high doses of radiation in a short time, making it suitable for patients who cannot undergo surgery. ^{1 2 3 11 12}

Research Team

Percy Lee

Principal Investigator

Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

3. Switzerland 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. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Outcomes of stereotactic ablative radiotherapy for central lung tumours: a systematic review. [2022]

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

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

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

Weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: analysis of safety and efficacy in patients with renal impairment. [2022]

7. United States 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. [2022]

8. United States 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. [2019]

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

Carboplatin in non-small cell lung cancer: an update on the Cancer and Leukemia Group B experience. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. [2018]

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

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]

12. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy in T1-2N0M0 small cell lung cancer: A systematic review and meta-analysis. [2022]