Status:
UNKNOWN
IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer
Lead Sponsor:
LuBing
Conditions:
Non-Small Cell Lung Cancer
Nonsmall Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for the treatment of stag...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed stage IV NSCLC\[UICC 2017 8th edition\] with known sensitive EGFR mutations(confirmed by tissue or blood).
- Have not received one or more prior treatments
- 18 to 80 years of age.ECOG performance status 0～2 or KPS≥60
- Have distant metastatic lesions≤5；and have clear consciousness when the metastatic sites were brain; and have no influence on pulmonary function when the metastatic sites were lung.
- Have no contraindications in radiotherapy, EGFR-TKI and chemotherapy
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcl Platelets ≥ 100,000/mcl Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 2.0 x IULN AST (SGOT) / ALT (SGPT) ≤ 3.0 x IULN; if liver metastases, ≤ 5.0 x IULN Serum creatinine ≤ 1.5 x ULN LVEF ≥ 50% performed no more than 4 weeks prior to enrollment. FEV1\>50%，mild-moderate pulmonary function dysfunction.
- Able to understand and willing to sign a Human Research Protection Office (HRPO) approved written informed consent document (or that of legally authorized representative, if applicable).
- With good compliance to the treatment and Follow-up
Exclusion
- Evidence of small cell, large cell neuroendocrine or carcinoid histology.
- Non-stage IV NSCLC and ECOG performance status 3～5 or KPS\<60
- Have a serious or uncontrolled medical condition that could compromise the patients' ability to adhere to the protocol.
- Malignant pleural effusion and pericardial effusion
- Uncontrolled intercurrent illness including, but not limited to, hypertension , diabetes mellitus ,ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding: Patient must have a negative pregnancy test within 14 days of study entry.
- Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer such as in situ of the cervix. considered cured by surgical resection or radiation). Patients who have had another malignancy in the past but have been disease free for more than 5 years are eligible.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to EGFR-TKI or other agents used in the study.
- With poor compliance
- The researchers consider it inappropriate to participate in the study
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03258671
Start Date
October 1 2017
End Date
December 30 2020
Last Update
August 25 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The affiliated hospital of Guizhou medical university
Guiyang, Guizhou, China, 550004