Clinical trial NCT03258671: IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer
Official title: IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer: Results of a Randomised,Openlabel,Multicentre Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Nonsmall Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Lead sponsor: Guizhou Medical University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 stage IV non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.

In this study, the investigators aim to verify the following hypothesis:

* whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy, Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung recurring or progressing similarily.
* Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal tissue dose/volume tolerance than concurrent regimen.
* the survival can be improved by using this new molecular Target-radiotherapy method.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients.
timeFrame: >4 weeks post treatment
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: Up to 5 years
measure: Disease control rate (DCR)
timeFrame: Up to 5 years
measure: Adverse events (toxicities)
timeFrame: Up to 5 years
measure: Local regional progression-free survival（LRPFS）
timeFrame: Time Frame: Up to 5 years
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The affiliated hospital of Guizhou medical university
state: Guizhou
Study officials:
affiliation: ouyangww103173@163.com
name: Lu Bing, Director
role: STUDY_DIRECTOR
References:
citation: Li Q, Liang N, Zhang X, Zhang Y, Ouyang W, Su S, Ma Z, Hu Y, Geng Y, Chen X, Lu B. Reasonable Timing of Radiotherapy for Stage IV Non-Small-Cell Lung Cancer During Targeted Therapy Based on Tumour Volume Change. Front Oncol. 2021 Sep 23;11:705303. doi: 10.3389/fonc.2021.705303. eCollection 2021.