High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Not Applicable

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT03598517
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-15
• Study First Submitted QC: 2018-07-15
• Study First Posted: 2018-07-26
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-25
• Primary Completion: 2021-05-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
overall survival rate	2 year	survival time was measured from the date of study enrollment to the date of death or last follow-up

Secondary Outcome Measures

Name	Time	Method
toxicities	2 year	Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4.

Trial Locations

Locations (1)

Shanghai Genernal Hospital; 🇨🇳 Shanghai, Shanghai, China