Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer

NCT01185639 | Completed Results DMC FDA Device

• 3 other identifiers: IRB00013994NCI-2010-01877CCCWFU 62110
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line chemotherapy is feasible, safe, provides durable local control of treated lesions and improves time to progression compared to historical controls. Patients are eligible for enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.

Conditions

Non-Small-Cell Lung Carcinoma; Liver Cancer; Adrenal Cancer

Keywords

lung cancer; metastatic; SBRT; Stereotactic body radiation therapy; liver; spine; adrenal; bone cancer; Spinal Column

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or \<25%or original size; partial \>30% decrease of target lesion; stable \<30% decreased of target lesion and; local failure increase \>20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.

  up to 2 years

Secondary Outcomes (4)

• To Assess Physical Function for This Cohort of Patients

  up to 3 months after treatment

• Number of Participants With Local Control

  up to 2 years

• Overall Survival

  up to 4 years

• Impact of Treatment on Quality of Life (FACT-L)

  up to 3 months after treatment

Study Arms (1)

SBRT for metastatic NSCLC

EXPERIMENTAL

SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions

Radiation: stereotactic body radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques

Also known as: Elekta Bodyframe, Cyberknife

SBRT for metastatic NSCLC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General
• Patients with AJCC sixth edition metastatic non-small cell lung carcinoma
• Pathologic diagnosis of stage 4 non-small cell lung cancer prior to enrollment.
• Patients must have response or stable disease by RECIST criteria after 4 cycles of first-line chemotherapy
• Maximum of number of lesions per patient will be 5 total. .
• Patients with solitary brain metastases previously treated with surgery or stereotactic radiosurgery (+/- WBRT) and currently controlled at the time of study enrollment are also eligible. Patients with history of brain metastases must have an MRI showing no active brain metastases within 80 days of study enrollment. Patients with a history of brain metastases may have up to 5 extracranial sites of disease except for those with an untreated primary tumor where section 3.1.3.3 will also apply.
• Patients with newly diagnosed stage IV NSCLC with an untreated primary must no more than 3 active extracranial metastatic lesions other than the primary site and regional lymph nodes.
• Age ≥ 18 years old
• Performance Status 0-2 (ECOG)
• A signed study specific consent form is required.
• Lung (only applies to patients with active lung lesions)
• Patients cannot have more than 3 lung lesions
• All lung lesions must be visible on CT imaging
• Cumulative diameter of lung lesions must be \<7cm
• Patients may have active mediastinal disease in a single mediastinal nodal station if he/she has not received prior mediastinal RT

You may not qualify if:

• Primary tumor progression on first-line chemotherapy
• Patients with complete response to first-line chemotherapy with no measurable target for SBRT
• \>5 metastatic lesions or \>3 metastatic lesions in patients with an untreated primary site are ineligible (ipsilateral hilar and mediastinal lymph nodes are considered part of an untreated primary site and are not counted as metastatic lesions)
• Solitary brain metastases and an untreated node positive primary tumor, without other extracranial metastases amenable to SBRT are ineligible
• Retreatment of previously irradiated tumor will be excluded per 3.1.9.2 above.
• Mediastinal lymph nodes involving multiple mediastinal nodal stations or N3 disease are ineligible.
• Pleural effusion known to be malignant or visible of chest xray.
• Untreated brain metastases
• Bilateral adrenal metastases
• Metastases in other sites not considered amenable to SBRT
• Patients with liver metastases cannot have received prior upper abdominal radiation
• Prior radiation to spine (most commonly in treatment of primary lung cancer), cannot have received \>50Gy to the spinal cord at the level of current vertebral metastases
• Clinical or radiographic evidence of spinal cord compression are ineligible
• Patients with serious, uncontrolled, concurrent infection(s).
• Weight loss (\>10% of body weight) in the prior 3 months.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

Coastal Carolina Radiation Oncology

Wilmington, North Carolina, 28401, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Petty WJ, Urbanic JJ, Ahmed T, Hughes R, Levine B, Rusthoven K, Papagikos M, Ruiz JR, Lally BE, Chan M, Clark H, D'Agostino RB Jr, Blackstock AW. Long-Term Outcomes of a Phase 2 Trial of Chemotherapy With Consolidative Radiation Therapy for Oligometastatic Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):527-535. doi: 10.1016/j.ijrobp.2018.06.400. Epub 2018 Jul 10.

  PMID: 30003996 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Liver Neoplasms; Adrenal Gland Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Bone Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. William Blackstock
• Organization: Wake Forest University Health Sciences

ablackst@wakehealth.edu

336-713-6501

Study Officials

• William Blackstock, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: August 18, 2010
• First Posted: August 20, 2010
• Study Start: August 1, 2010
• Primary Completion: June 27, 2016
• Study Completion: June 27, 2016
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2019-11

Locations

US (2)