Surgery vs Stereotactic Radiotherapy for Lung Cancer

(VALOR Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Metastasis, Prior lung cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for lung cancer?

Research shows that stereotactic ablative radiotherapy (SABR) is a standard treatment for early-stage non-small cell lung cancer (NSCLC) and offers similar local control and safety compared to surgery, especially for patients who cannot undergo surgery. SABR has been shown to improve tumor control and overall survival in patients with primary and secondary lung tumors.

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Is stereotactic radiotherapy safe for treating lung cancer?

Stereotactic radiotherapy, also known as SABR or SBRT, is generally safe for treating lung cancer, but it can cause some side effects, including potential damage to nearby structures. While serious toxic effects are rare, some patients may experience changes that require long-term management.

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How does the treatment of surgery vs stereotactic radiotherapy for lung cancer differ from other treatments?

Stereotactic radiotherapy (SBRT/SABR) is a non-invasive treatment that delivers high doses of radiation with precision over a few sessions, making it a suitable option for patients who cannot undergo surgery. It offers similar outcomes to surgery for early-stage non-small cell lung cancer (NSCLC), especially for those who are medically inoperable, providing an alternative to the traditional surgical removal of lung tissue.

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Eligibility Criteria

This trial is for adults over 18 with stage I Non-Small Cell Lung Cancer (NSCLC) that's less than or equal to 5cm, confirmed by biopsy or imaging. They must be fit for surgery or stereotactic radiotherapy, have a Karnofsky performance status of at least 70, and no history of certain cancers or thoracic treatments. Pregnant women and those with metastatic disease are excluded.

Inclusion Criteria

I am considered fit for lung surgery that is not a wedge resection.

I am 18 years old or older.

I have or am suspected to have early-stage lung cancer.

Exclusion Criteria

I have had cancer before, but it wasn't follicular lymphoma, chronic lymphocytic leukemia, or hormone-sensitive prostate cancer.

I am a woman under 61 or haven't had a hysterectomy and my pregnancy test is positive.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either stereotactic radiotherapy or undergo surgery based on randomization

Varies based on treatment type

Multiple visits for treatment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular visits every 6 months

Long-term follow-up

Participants are monitored for overall survival and lung cancer mortality

Up to 10 years

Participant Groups

The study compares two treatments for early-stage lung cancer: traditional lung surgery (anatomic pulmonary resection) versus a newer approach called stereotactic radiotherapy. It aims to find out which treatment might be better by randomly assigning participants to one of the two options.

Group I: Stereotactic radiotherapy Experimental Treatment 1 Intervention

Stereotactic radiotherapy is an FDA approved treatment for lung cancer. However, for purposes of this study, it is being delivered to an operable population that is typically treated with surgical resection. Participants randomized to stereotactic radiotherapy will be treated according to the location of the tumor. Peripheral tumors will receive either 18 Gy x 3, 14 Gy x 4, or 11.5 Gy x 5 fractions, while central tumors will be treated with 10 Gy x 5. There will not be any elective coverage of local microscopic spread or regional lymph nodes.

Group II: Surgery Active Control 1 Intervention

Participants randomized to surgery will undergo a standard lobectomy or limited anatomic pulmonary resection (segmentectomy) under general anesthesia. Non-anatomic (wedge) resections are not permitted. Pathological specimens must contain a separately divided pulmonary artery and bronchus, as well as sampled lymph nodes from mediastinal lymph node stations. Participants found to have incidental nodal involvement after surgery will be referred for adjuvant chemotherapy, with our without postoperative radiotherapy.

Anatomic Pulmonary Resection is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Anatomic Pulmonary Resection for:

• Non-small cell lung cancer
• Stage I lung cancer

🇺🇸 Approved in United States as Anatomic Pulmonary Resection for:

• Non-small cell lung cancer
• Stage I lung cancer

🇨🇦 Approved in Canada as Anatomic Pulmonary Resection for:

• Non-small cell lung cancer
• Stage I lung cancer

🇯🇵 Approved in Japan as Anatomic Pulmonary Resection for:

• Non-small cell lung cancer
• Stage I lung cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Durham VA Medical Center, Durham, NC Durham, NC

Atlanta VA Medical and Rehab Center, Decatur, GA Decatur, GA

Bay Pines VA Healthcare System, Pay Pines, FL Bay Pines, FL

Edward Hines Jr. VA Hospital, Hines, IL Hines, IL

More Trial Locations

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

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

Stereotactic ablative radiation therapy in lung cancer: an emerging standard. [2019] Significant advances have been made in the field of stereotactic ablative radiotherapy (SABR) for the treatment of pulmonary neoplasms in recent years. This review aims to summarize recent salient evidence on SABR for early-stage nonsmall cell lung cancer (ES-NSCLC).

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

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013] Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.

3. New Zealand pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy or stereotactic ablative radiotherapy versus surgery for patients with T1-3N0M0 non-small cell lung cancer: a systematic review and meta-analysis. [2022] Stereotactic body radiotherapy (SBRT) or stereotactic ablative radiotherapy (SABR) has been reported to be a comparable alternative therapy to surgery for patients with T1-3N0M0 non-small cell lung cancer (NSCLC). However, it has not been clarified whether SBRT/SABR is as effective as surgery. We conducted this study to compare the efficacy of SBRT/SABR and surgery in the treatment of T1-3N0M0 NSCLC.

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

Measuring the Integration of Stereotactic Ablative Radiotherapy Plus Surgery for Early-Stage Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial. [2022] Stereotactic ablative radiotherapy (SABR) is a standard treatment option in patients with medically inoperable early-stage non-small cell lung cancer (NSCLC), yet the pathologic complete response (pCR) rate after SABR is unknown. Neoadjuvant SABR in patients with cancer who are fit for resection has been hypothesized to improve local control and induce antitumor immune activity, potentially leading to better outcomes.

5. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. [2022] Stereotactic ablative body radiotherapy (SABR) represents a technological breakthrough in radiotherapy technique, with proven benefits to patients in terms of improved tumour control and overall survival. The key components of SABR are described. The current evidence base for SABR for the treatment of primary and secondary lung tumours is appraised, and key ongoing trials are identified.

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

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. [2023] Stereotactic ablative radiotherapy (SABR) is used for treating lung tumors but can cause toxic effects, including life-threatening damage to central structures. Retrospective data suggested that small tumors up to 10 cm3 in volume can be well controlled with a biologically effective dose less than 100 Gy.

7. Ireland pubmed.ncbi.nlm.nih.gov

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. [2023] Stereotactic ablative radiation therapy (SABR) is the standard of care for inoperable early-stage non-small-cell lung cancer. Although the probability of grade ≥ II toxicities is low, many patients present radiological subclinical toxicities usually associated with long-term patient management challenges. We evaluated radiological changes and correlated them with the received Biological Equivalent Dose (BED).

8. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for lung tumors at the pulmonary hilum. [2021] High-dose irradiation to the pulmonary hilar region is generally considered to be of high risk in causing bronchial injury. The aim of this retrospective study is to investigate the safety and efficacy of stereotactic body radiotherapy (SBRT) for patients with lung tumors in the pulmonary hilum.

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

Long-term outcomes in patients with central and ultracentral non-small cell lung cancer treated with stereotactic body radiotherapy: single-institution experience. [2023] Treatment-related toxicity following stereotactic ablative radiotherapy (SABR) in patients with central and ultracentral non-small cell lung cancer (NSCLC) is of potential concern, and the best regimens are still being explored. This study aimed to evaluate the clinical outcomes and toxicities of the patients with ultracentral and central NSCLC treated with SABR at our institution.

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

Patterns of Recurrence and Survival after Surgery or Stereotactic Radiotherapy for Early Stage NSCLC. [2022] Surgery is the standard treatment for early stage non-small-cell lung cancer (NSCLC). For medically inoperable patients, stereotactic ablative radiotherapy (SABR) has emerged as widely used standard treatment. The aim of this study was to analyze survival and patterns of tumor recurrence in patients with clinical stage I NSCLC treated with surgery or SABR.

11. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy and surgery: two gold standards for early-stage non-small cell lung cancer? [2020] There is growing clinical equipoise between surgery and stereotactic ablative radiotherapy (SABR) in the management of early-stage non-small cell lung cancer (ES-NSCLC). Increasing evidence suggest similar outcomes between these modalities. Through the guidance of a multidisciplinary team, a shared decision making approach in this setting in favoured.

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

Stereotactic body radiation therapy versus surgical resection for stage I non-small cell lung cancer. [2022] Stereotactic body radiation therapy has been proposed as an alternative local treatment option for high-risk patients with early-stage lung cancer. A direct comparison of outcomes between stereotactic body radiation therapy and surgical resection has not been reported. This study compares short-term outcomes between stereotactic body radiation therapy and surgical treatment of non-small cell lung cancer.