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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Non-small Cell Lung Cancer

Treatments: Radiation: high dose chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03598517

SGH201816

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

high dose chemoradiotherapy

Experimental group

Description:

all eligible patients receive image-guided intensity-modulated radiotherapy 60 Gy in 30 fractions over 6 weeks and concurrent weekly paclitaxel and cisplatin，followed by hyperfractionated intensity-modulated radiotherapy boost to residual metabolic disease concurrent with the same chemotherapy regimen, followed by adjuvant chemotherapy 6 weeks after completion of radiation therapy.

Treatment:

Radiation: high dose chemoradiotherapy