Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy

NCT02357992 | Completed Results

• 2 other identifiers: 2007-0870NCI-2015-00536
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to evaluate the outcome of a standard radiation treatment called stereotactic radiotherapy (SRT) for NSCLC. Specifically, researchers want to learn if standard SRT has as good of an outcome at 3 years after the procedure. The safety of the study treatment will also be analyzed.

Conditions

Lung Cancer

Keywords

Lung cancer; Non-small cell lung cancer; NSCLC; Squamous cell carcinoma; Adenocarcinoma with or without BAC features; Large cell carcinoma with or without neuroendocrine features; Neuroendocrine carcinoma; Bronchioloalveolar cell carcinoma; Stereotactic radiotherapy (SRT); SRT; Stereotactic ablative radiotherapy; SABR; Radiation therapy; XRT

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Survival (OS) at 3 Years

  OS defined as the length of time measured from the start of treatment until 3 years post-treatment or death, whichever come first.

  3 years

Study Arms (1)

Stereotactic Radiotherapy (SRT)

EXPERIMENTAL

Participants receive stereotactic body radiotherapy (SABR) once a day for 3-4 days in a row. 50Gy delivered in 4 fractions for central tumor, or 54Gy delivered in 3 fractions for peripheral tumor.

Radiation: Stereotactic Body Radiotherapy (SABR)

Interventions

Stereotactic Body Radiotherapy (SABR) RADIATION

SABR once a day for 3-4 days in a row, 50Gy in 4 fractions for central tumor, or 54Gy in 3 fractions for peripheral tumor.

Also known as: SABR, XRT, Radiation therapy

Stereotactic Radiotherapy (SRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of non-small cell cancer will be required by either biopsy or cytology. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without BAC features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.
• Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised IASLC stage IA based on the following combination of TNM staging: T1a,N0,M0 or T1b,N0,M0
• A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with short axis diameter \</= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm short axis diameter of hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Solitary pulmonary lesions \</= 6mm will not be considered significant.
• Patients must be considered a candidate for surgical resection of the primary tumor. Standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline FEV1 \> 40% predicted, post-operative predicted FEV1 \> 30% predicted, diffusion capacity \> 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption \> 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease.
• Patients must be \>/= 18 years of age.
• The patient's Zubrod performance status must be Zubrod 0-2.
• PET/CT scan to include both lungs, the mediastinum, and adrenal glands; Primary tumor dimension will be measured on diagnostic CT and again on simulation CT. Must be done within 10 weeks prior to study entry.
• Mediastinoscopy or endobronchial ultrasound (EBUS) guided biopsy of mediastinal lymph nodes is required for all patients. Must be done within 10 weeks of study entry.
• MRI or CT scans of Brain if there are symptoms or signs suggesting brain metastases, must be done within 10 weeks prior to study entry.
• Invasive Mediastinal Staging - All patients with CT and/or PET evidence of hilar (level 10) or mediastinal lymph nodes \> 1.0 cm in the shortest diameter must be staged by either cervical mediastinoscopy, esophageal endoscopic ultrasound guided biopsy, or endobronchial ultrasound guided biopsy.
• Patients must sign a study-specific consent form.
• Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.

You may not qualify if:

• Patients with primary tumors \> 3 cm.
• Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor).
• Direct evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 3 years other than nonmelanomatous skin cancer or in situ cancer.
• Previous lung or mediastinal radiotherapy.
• Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression.
• Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
• Cannot achieve acceptable SABR planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures (see RT techniques).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Chang JY, Mehran RJ, Feng L, Verma V, Liao Z, Welsh JW, Lin SH, O'Reilly MS, Jeter MD, Balter PA, McRae SE, Berry D, Heymach JV, Roth JA; STARS Lung Cancer Trials Group. Stereotactic ablative radiotherapy for operable stage I non-small-cell lung cancer (revised STARS): long-term results of a single-arm, prospective trial with prespecified comparison to surgery. Lancet Oncol. 2021 Oct;22(10):1448-1457. doi: 10.1016/S1470-2045(21)00401-0. Epub 2021 Sep 13.

  PMID: 34529930 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Neuroendocrine

Interventions

Radiosurgery; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Adenocarcinoma; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Jack Roth, MD- Professor, Thoracic & Cardio Surgery-Rsch
• Organization: UT MD Anderson Cancer Center

jroth@mdanderson.org

(713) 792-7664

Study Officials

• Jack Roth, MD, BA

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: April 5, 2010
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: October 14, 2022
• Results First Posted: October 14, 2022

Record last verified: 2022-10

Locations

US (1)