Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)

Stage IV EGFR Mutated Non-Small Cell Lung Cancer Clinical Trial

— Sindas  

Official title:

Tyrosine-kinase Inhibitor （TKI） With or Without SBRT in Newly Diagnosed EGFRm Advanced Staged Lung Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02893332
• Other study ID #: 2016 15-1
• Status: Terminated
• Phase: Phase 3
• Start date: January 15, 2016
• Est. completion date: August 30, 2020

Study information

• Verified date: January 2021
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to TKI alone.

Description:

This protocol is a randomized phase III trial of TKI versus consolidative Stereotactic Body Radiation Therapy (SBRT) plus TKI for patients with Stage IV non-small cell lung cancer (NSCLC).

Prior to accrual on the trial, patients with Stage IV NSCLC will be tested with positive EGFR mutation. Patients who with fewer than or equal to 5 sites of oligometastatic disease will be randomized toTKI or consolidative SBRT to all sites of disease (followed by TKI at the medical oncologist's discretion). Choices of TKI will be determined by the medical oncologist based on clinical appropriateness.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (=5 discrete lesions of disease irrespective of location, inclusive of the primary lesion):

• all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology

• all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion.

• No brain metastasis is allowed.

• Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib.

• Lung adenocarcinoma histology confirmed

• Karnofsky Performance Status = 70%

• Adequate bone marrow, liver and renal function, as specified below:

• Absolute Neutrophil Count (ANC) = 1.5 x 109/L

• Hemoglobin = 8 g/dL

• Platelets = 100 x 109/L

• Serum total bilirubin = 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)

• AST and ALT = 2.5 x ULN or = 5 x ULN if liver metastases are present

• Serum creatinine = 1.5 x upper limit of normal or creatinine clearance = 60ml/min for patients with creatinine levels above institutional normal.

• For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment

• Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

• Treatment with TKI prior to developing metastatic disease

• Malignant pleural effusion or pleural disease

• Leptomeningeal disease or brain metastasis.

• Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy

• Women who are breastfeeding or pregnant

• Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment.

• Any medical co-morbidities that would preclude surgery or radiation therapy

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Stage IV EGFR Mutated Non-Small Cell Lung Cancer

Intervention

Radiation:
• Radiation: SBRT
A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL during a 1-week run-in period after which SBRT will be delivered to the all oligometastatic lesions concurrently with the TKI. The SBRT dose will be , ranging from at 25Gy (5 Gy per fraction) to 40 Gy (8 Gy per fraction).

Drug:
• TKI (Gefitinib or Tarceva )
A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL, no local therapy apply to oligo-metastatic sites.

Locations

Country	Name	City	State
China	Sichuan PPH, Cancer Center	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Evaluate the effect of TKI with or without SBRT on progression free survival,to describe local control and out-of-field disease progression	4 years
Secondary	Overall survival	To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.	4 years
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])	Using CTCAE system to evaluate toxicity profile	4 years