Clinical trial NCT03598517: High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer
Official title: Intensity-modulated Hyperfractionated Radiotherapy Boost to Residual Metabolic Disease Following Standard Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.

Detailed description: Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival

Eligibility criteria: Inclusion Criteria:

* Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
* Age 1 8-75.
* Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2.
* Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
* No prior radiation to the thorax that would overlap with the current treatment field.
* Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/ mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</ =1 .5 times ULN.
* A signed informed consent must be obtained prior to therapy.
* Induction chemotherapy is allowed.
* Life expectancy more than 3 months

Exclusion Criteria:

* Patients with any component of small cell lung carcinoma are excluded from this study.
* Patients with evidence of a malignant pleural or pericardial effusion are excluded.
* Prior radiotherapy that would overlap the radiation fields.
* Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
* Known hypersensitivity to paclitaxel.
* Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
* Conditions precluding medical follow-up and protocol compliance

Primary outcomes:
measure: overall survival rate
timeFrame: 2 year
Secondary outcomes:
measure: toxicities
timeFrame: 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Genernal Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Tingfeng Chen, MD
role: STUDY_DIRECTOR
References: