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.
Radiation: Radiation: SBRT
Drug: TKI (Gefitinib or Tarceva )
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Locations near you
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Full eligibility criteria for NCT02893332
Ages eligible for Study
18 Years to 99 Years
Genders eligible for Study
Accepts Healthy Volunteers
- 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
- 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
- Men and women of childbearing age must be willing to use effective contraception while
on treatment and for at least 3 months thereafter
- 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
- Any medical co-morbidities that would preclude surgery or radiation therapy
All locations for NCT02893332
Sichuan PPH, Cancer Center
Chengdu, Sichuan, China, 710062
View full eligibility
Tris trial is registered with FDA with number: NCT02893332. The sponsor of the trial is Sichuan Provincial People's Hospital and it is looking for 200 volunteers for the current phase.
Official trial title: Tyrosine-kinase Inhibitor （TKI） With or Without SBRT in Newly Diagnosed EGFRm Advanced Staged Lung Adenocarcinoma
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