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No recruitment.
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Patients with Non-small cell lung cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.
This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic Non-small cell lung cancer.
Eligible are patients with metastatic Non-small cell lung cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least three separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 35Gy in 10 fractions over a two week interval, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with thymalfasin. Abscopal response is evaluated by assessing clinical and PET/CT response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy and Thymalfasin arm | Experimental | Patients with metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment. | week 7- week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study. | year 0- year 2 | |
| The proportion of patients alive with abscopal responses from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuqiang Wu, MD | Zhejiang Provincial People's Hospital | Study Chair |
| Yongshi Jia, MD | Zhejiang Provincial People's Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26095785 | Background | Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000077596 | Thymalfasin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 |
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| Thymalfasin | Drug | Metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin; Thymalfasin treatment is given twice a week with an interval of 3-4 days each week. |
|
|
| year 0- year 2 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |