Ignite Creation Date:
2024-05-06 @ 7:30 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02542930
Status:
WITHDRAWN
Last Update Posted:
2019-03-26
First Post:
2015-09-03
Brief Title:
Abscopal Effect for Metastatic Non-small Cell Lung Cancer
Sponsor:
Zhejiang Provincial Peoples Hospital
Organization:
Zhejiang Provincial Peoples Hospital
Study Overview
Official Title:
A Phase II Study of Radiotherapy and ZADAXINs Thymalfasin Induced Abscopal Effect in Patients With Heavily Pretreated Metastatic Non-small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 To observe immunity-mediated tumor response outside the radiation field abscopal effect after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung cancer patients
2 To induce the efficacy effectiveness of a new combination of therapy chemoradiotherapy and thymalfasin for heavily pretreated metastatic Non-small cell lung cancer patients
3 To explore the role of PETCT scanning to assess tumor responseabscopal effect
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
1 To observe immunity-mediated tumor response outside the radiation field abscopal effect after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung cancer patients
2 To induce the efficacy effectiveness of a new combination of therapy chemoradiotherapy and thymalfasin for heavily pretreated metastatic Non-small cell lung cancer patients
3 To explore the role of PETCT scanning to assess tumor responseabscopal effect
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
Detailed Description:
1 To observe immunity-mediated tumor response outside the radiation field abscopal effect after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung cancer patients
2 To induce the efficacy effectiveness of a new combination of therapy chemoradiotherapy and thymalfasin for heavily pretreated metastatic Non-small cell lung cancer patients
3 To explore the role of PETCT scanning to assess tumor responseabscopal effect
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 PETCT 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 PETCT 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
2 To induce the efficacy effectiveness of a new combination of therapy chemoradiotherapy and thymalfasin for heavily pretreated metastatic Non-small cell lung cancer patients
3 To explore the role of PETCT scanning to assess tumor responseabscopal effect
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 PETCT 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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None