Locally Advanced Non-Small Cell Lung Cancer, Safety, Thoracic Radiotherapy
Conditions
Keywords
thoracic radiotherapy, non-small cell lung carcinoma, locally advanced, safety, Anlotinib
Brief summary
Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.
Interventions
DRUGAnlotinib
For patients treated with conventional Intensity-Modulated Radiation Therapy (IMRT), the median prescribed dose was 60 Gy/30 fractions (range: 50.0-70.0 Gy, in 25-35 fractions) (median BED10 72 Gy, range: 60-84 Gy) to the planning target volume (PTV). As for patients with IMRT-based simultaneously integrated boost (SIB), the median prescribed dose was 59.92 Gy/28 fractions (range: 50.0-70.0 Gy, in 25-33 fractions) (median BED10 72.74 Gy, range: 60-84 Gy) to the planning gross tumor volume (PGTV), and 50.4 Gy/28 fractions (range: 45-59.4 Gy, in 25-33 fractions) (median BED10 59.47 Gy, range: 53.1-70.1 Gy) to the PTV. It should be noted that the PTV in the SIB group contains the PGTV. Anlotinib was administered orally concurrently with the first day of radiotherapy, at a dose of 12 mg for a maximum of three cycles. Each cycle was defined as 2 weeks on-treatment followed by 1 week off-treatment. If intolerance occurs, the dose may be reduced to 8-10 mg/day or stopped.
Sponsors
JIANYANG WANG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A phase II randomized trial (registered in Clinical Trials.gov as NCT05888402) of unresectable stage III NSCLC patients undergone definitive concurrent chemoradiotherapy was prespecified to compare the 2-year PFS difference with that of current trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with histologically or cytologically confirmed negative EGFR (including EGFR exon 19 deletion or L858R mutations) or ALK/ROS1-mutated locally advanced unresectable NSCLC were screened. Inclusion Criteria: 1. ≥18 years old with no restrictions on sex; 2. Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma; 3. Eastern cooperative oncology group (ECOG) score ≤2 was required; 4. Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression; 5. .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk; 6. No symptoms of hemoptysis; 7. Adequate hepatic and renal functions with a negative urine protein; 8. Expected survival of more than 6 months.
Exclusion criteria
1. currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ; 2. previous malignancy within five years; 3. thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months; 4. uncontrolled or active pulmonary inflammation; 5. participated in other clinical trials; 6. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival (PFS) | From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) | From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months |
| Local regional recurrence (LR) | From the first day of radiotherapy to the occurrence of clinical and/or biopsy-proven recurrence within the bronchial stump, ipsilateral hilum, mediastinum, or supraclavicular, whichever occurs first, assessed up to 60 months |
| Distant metastasis (DM) | From the first day of radiotherapy to the occurrence of any evidence of metastatic disease beyond the locoregional regions previously mentioned, assessed up to 60 months |
| Acute toxicity | From the first day of radiotherapy and up to the 3-month post-radiotherapy follow-up visit |
Countries
China
Contacts
Primary Contactjianyang wang, MD
Outcome results
None listed