Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527898
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer a Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Concurrent chemoradiotherapy has long been the standard modality for locally advanced small-cell lung cancer which could achieve median overall survival of 25 mos Conventional fractionation of 66Gy33f and hyperfractionation of 45Gy30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study With the introduction of immune checkpoint inhibitors ADRIATIC study concluded that consolidative Durvalumab after concurrent chemoradiotherapy could achieve a far longer median overall survival of 559 months compared with 334 months for concurrent chemoradiotherapy Recently several studies have demonstrated the safety and efficacy of hypofractionated radiotherapy 3 to 4 Gy for limited-stage small-cell lung cancer Hypofractionated radiotherapy processes the advantage of short treatment duration compared with conventional fractionated radiotherapy which may allow the early participation of immunotherapy Therefore we suppose that whether hypofractionated radiotherapy combined with immunotherapy could improve the survival of limited-stage of small-cell lung cancer
Detailed Description:
Trial design To enroll 45 patients diagnosed with limited stage small-cell lung cancer to receive concurrent chemoradiotherapy with consolidative Adebrelimab maintenance
Primary endpoint Progression-free Survival Secondary endpoint 2-year progression-free survival 2-year overall survival rate
All enrolled patients are proposed to receive concurrent chemoradiotherapy and consolidative Adebrelimab maintenance up to 2 years After concurrent chemoradiotherapy hippocampus-sparing prophylactic cranial irradiation or MRI surveillance are both allowed
Chemotherapy Etoposide 80-100mgm2 day 1 2 3 and cisplatin 75-80mgm2 day 1 amp carboplatin AUC 5 day 1 q3w for totally 6 cycles
Radiotherapy began at the second cycle of chemotherapy followed by hippocampus-sparing prophylactic cranial irradiation or MRI surveillance
Immunotherapy consolidation began at the third cycle of chemotherapy Adebrelimab 1200mg q3w to 2 year or disease progression amp untolerated toxicity
Radiotherapy details
Radiotherapy CT simulation 4-Dimensional CT 4D-CT with intravenous contrast is recommended for simulation Scan thickness should be less than 5 mm Thermal mask or vacuum bag is recommended
Target Delineation Considering hypofraction and involved field irradiation IFI only Internal Tumor Volume ITV should be delineated without the need to delineate Clinical Tumor Volume CTV
Delineation of ITV ITV should include pulmonary gross tumor and metastatic mediastinal lymph nodes PET-CT registration with simulation CT is recommended for patients with obstructive atelectasis For patients with suspected mediastinal lymph nodes Endobronchial Ultrasound-guided Transbronchial Needle Aspiration EBUS-TBNA is recommended
Production of Planning Tumor Volume PTV PTV is produced by a margin of 5 mm added to ITV Modification of PTV is suggested to respect anatomic boundary
Dosimetric Limitation 95 prescription dose should cover 100 PTV and 95 PTV should receive 100 prescription dose Total Lung V20lt23 Dmeanlt13Gy V5lt50 Spinal Cord Dmaxlt40Gy Heart V30lt40 Dmeanlt25Gy Esophagus V40lt5cc
Treatment Implementation Radiotherapy is implemented every day Cone-beam CT should be utilized every day to minimize set-up error
Follow-up Patients should be follow-up every three months right after the completion of the final cycle of immunotherapy to 3 years after that Then follow-up every half year is allowed to 5 years After 5 years follow-up every year is appropriate In follow-up chest CT and abdominal ultrasonography should be implemented Cranial MRI should be performed every half year Bone scan should be undertaken every year for all patients
Inclusion Criteria
1 18-70 years old
2 ECOG 0-1
3 Adequate organ function to tolerate chemotherapy immunotherapy and radiotherapy
4 Small-cell lung cancer
5 Limited stage confirmed by cranial MRI chest CT abdominal ultrasonograph bone scan or cranial MRI and PET-CT
6 Signature of inform consent
Exclusion Criteria
1 Younger than 18 years old or older than 70 years old
2 ECOGgt1
3 Inadequate organ function to tolerate chemotherapy immunotherapy and radiotherapy
4 Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid large-cell neuroendocrine carcinoma
5 Extensive stage confirmed by cranial MRI chest CT abdominal ultrasonograph bone scan or cranial MRI and PET-CT
6 No signature of inform consent
Primary endpoint Progression-free Survival Secondary endpoint 2-year progression-free survival 2-year overall survival rate
All enrolled patients are proposed to receive concurrent chemoradiotherapy and consolidative Adebrelimab maintenance up to 2 years After concurrent chemoradiotherapy hippocampus-sparing prophylactic cranial irradiation or MRI surveillance are both allowed
Chemotherapy Etoposide 80-100mgm2 day 1 2 3 and cisplatin 75-80mgm2 day 1 amp carboplatin AUC 5 day 1 q3w for totally 6 cycles
Radiotherapy began at the second cycle of chemotherapy followed by hippocampus-sparing prophylactic cranial irradiation or MRI surveillance
Immunotherapy consolidation began at the third cycle of chemotherapy Adebrelimab 1200mg q3w to 2 year or disease progression amp untolerated toxicity
Radiotherapy details
Radiotherapy CT simulation 4-Dimensional CT 4D-CT with intravenous contrast is recommended for simulation Scan thickness should be less than 5 mm Thermal mask or vacuum bag is recommended
Target Delineation Considering hypofraction and involved field irradiation IFI only Internal Tumor Volume ITV should be delineated without the need to delineate Clinical Tumor Volume CTV
Delineation of ITV ITV should include pulmonary gross tumor and metastatic mediastinal lymph nodes PET-CT registration with simulation CT is recommended for patients with obstructive atelectasis For patients with suspected mediastinal lymph nodes Endobronchial Ultrasound-guided Transbronchial Needle Aspiration EBUS-TBNA is recommended
Production of Planning Tumor Volume PTV PTV is produced by a margin of 5 mm added to ITV Modification of PTV is suggested to respect anatomic boundary
Dosimetric Limitation 95 prescription dose should cover 100 PTV and 95 PTV should receive 100 prescription dose Total Lung V20lt23 Dmeanlt13Gy V5lt50 Spinal Cord Dmaxlt40Gy Heart V30lt40 Dmeanlt25Gy Esophagus V40lt5cc
Treatment Implementation Radiotherapy is implemented every day Cone-beam CT should be utilized every day to minimize set-up error
Follow-up Patients should be follow-up every three months right after the completion of the final cycle of immunotherapy to 3 years after that Then follow-up every half year is allowed to 5 years After 5 years follow-up every year is appropriate In follow-up chest CT and abdominal ultrasonography should be implemented Cranial MRI should be performed every half year Bone scan should be undertaken every year for all patients
Inclusion Criteria
1 18-70 years old
2 ECOG 0-1
3 Adequate organ function to tolerate chemotherapy immunotherapy and radiotherapy
4 Small-cell lung cancer
5 Limited stage confirmed by cranial MRI chest CT abdominal ultrasonograph bone scan or cranial MRI and PET-CT
6 Signature of inform consent
Exclusion Criteria
1 Younger than 18 years old or older than 70 years old
2 ECOGgt1
3 Inadequate organ function to tolerate chemotherapy immunotherapy and radiotherapy
4 Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid large-cell neuroendocrine carcinoma
5 Extensive stage confirmed by cranial MRI chest CT abdominal ultrasonograph bone scan or cranial MRI and PET-CT
6 No signature of inform consent
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