Clinical trial NCT02841228: Intensity-modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) for Inoperable Non-small-cell Lung Cancer
Official title: Intensity-modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: SIB-IMRT
NSCLC
Radiochemothearpy
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 40
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: Lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Detailed description: Lung cancer is one of the most common cancer and the leading causes of cancer death in patients worldwide. Approximately 80% of NSCLC were inoperable. Concurrent chemo-radiation therapy (CCRT) is a standard treatment for locally advanced NSCLC who are not candidates for surgery. Nevertheless, the prognosis of patients with locally advanced NSCLC (LA-NSCLC) is still poor. Local control (LC) after CCRT is one of the most important prognostic factors. Local failure is common after standard-dose chemoradiation for NSCLC. Studies of stereotactic body radiation therapy (SBRT) have shown a steep dose response in treating early-stage lung cancer. Improving the total dose and shortening the overall treatment time may be effective for improving the LC rates. However, problems remain due to the toxicity to adjacent critical structures (e.g,lung,heart, esophagus), the target volumes usually limits the doses escalated that cannot be safely delivered by conventional radiotherapy techniques. In order to avoid the acute and late radiation toxicity of normal tissues, different dose prescriptions can be delivered to different target volumes in the same fraction, which deliver a higher dose to the Gross Tumor Volume (GTV) and a relatively lower dose to the subclinical disease. The technique is called simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT).

Investigators hypothesized that use of SIB-IMRT technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed NSCLC, inoperable stages IIA-IIIB, according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
2. Performance status 0 to 2, ≤5% weight loss within the past 6 months
3. A forced expiratory volume at 1 second of ≥ 1 L
4. Life expectancy \> 3 months
5. No invasion of large vessels, heart, esophagus, spinal cord.
6. Based on conformal treatment planning, the volume of lung at or exceeding 20 Gy (V20) must have been≤30%, the mean esophagus dose≤34 Gy, and the volume of esophagus exceeding 55 Gy (V55)≤30%
7. Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
8. Without severe other diseases
9. Informed consent

Exclusion Criteria:

1. Had received prior thoracic radiotherapy
2. Supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome
3. Pregnant and lactating women
4. Serious complications
5. Other primary malignancies

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 12 months
Secondary outcomes:
measure: Treatment-related toxicities
timeFrame: up to 6 months
measure: Overall Response Rate (ORR)
timeFrame: up to 3 months
measure: Overall survival (OS)
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan province tumor pospital
state: Hunan
Study officials:
References:
citation: Yang W, Zeng B, Qiu Y, Tan J, Xu S, Cai Y, Zhou Y, Liu Z, Luo J, Wang H. A Dosimetric Comparison of Dose Escalation with Simultaneous Integrated Boost for Locally Advanced Non-Small-Cell Lung Cancer. Biomed Res Int. 2017;2017:9736362. doi: 10.1155/2017/9736362. Epub 2017 May 28.