Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479473
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Radiotherapy to All Residual Lesions After Chemoimmunotherapy
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
Chemoimmunotherapy Followed by All-residual-lesions Radiotherapy for Extensive-stage Small-cell Lung Cancer A Phase III Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis First-line chemotherapy could only achieve an overall survival of approximately 10 months CREST study demonstrated that the addition of thoracic radiotherapy to the patients who responded to chemotherapy could increase the 2-year survival rate from 3 to 13 CASPIAN and IMpower 133 trials have established the standard modality of first-line chemoimmunotherapy for extensive-stage small-cell lung cancer and prolonged the overall survival to 13 months Both the addition of thoracic radiotherapy and immunotherapy to chemotherapy were able to improve the survival Recently several retrospective studies have demonstrated the effectiveness and safety of the combination of thoracic radiotherapy and chemoimmunotherapy In a prospective study 4-6 cycles of first-line chemotherapy with Adebrelimab followed by thoracic radiotherapy achieved the progression-free survival of 101 months and overall survival of 214 months which was longer than chemoimmunotherapy Another study demonstrated not only thoracic radiotherapy but also radiotherapy to metastatic lesions could ameliorate survival Therefore we supposed that whether radiotherapy to all residual lesions after first-line chemoimmunotherapy could further improve survival for patients with extensive-stage small-cell lung cancer
Detailed Description:
Trial design To enroll 150 patients diagnosed with extensive-stage small-cell lung cancer to receive first-line chemoimmunotherapy with or without radiotherapy to all residual lesions
Primary endpoint Progression-free Survival Secondary endpoint Overall Survival Objective Response Rate Duration of Response Disease Control Rate
Randomization All the enrolled patients would be randomly assigned to chemoimmunotherapy group and chemoimmunotherapy with radiotherapy group using random table method
All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy etoposide and cisplatin amp carboplatin with Adebrelimab Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years
Chemoimmunotherapy Etoposide 80-100mgm2 day 1 2 3 and cisplatin 75-80mgm2 day 1 amp carboplatin AUC 5 day 1 and Adebrelimab 1200mg day 1 q3w totally 4 to 6 cycles
Immunotherapy maintenance Adebrelimab 1200mg q3w to 2 year or disease progression amp untolerated toxicity
Response evaluation After 4 to 6 cycles of chemoimmunotherapy patients would undertake response evaluation according to RECIST criteria These patients who were evaluated as partial response and stable disease could be included into the study and receive randomization
Radiotherapy to residual lesions Patients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions All residual lesions would be irradiated in a hypofractionated manner Radiotherapy should be completed in two weeks The suggested dose fraction for different lesion was as follows
Thoracic lesion 40Gy10f Cranial lesion Hippocamps-sparing whole brain irradiation of 30Gy10f with or without simultaneous integrated lesion boost of 40Gy10f Hepatic or adrenal lesion 40Gy10f Osseous lesion 30Gy10f or 40Gy10f Dose constraint to organs at risk could be referred to QUANTEC criteria 30Gy10f and Timmermans sheet 40Gy10f 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
Primary endpoint Progression-free Survival Secondary endpoint Overall Survival Objective Response Rate Duration of Response Disease Control Rate
Randomization All the enrolled patients would be randomly assigned to chemoimmunotherapy group and chemoimmunotherapy with radiotherapy group using random table method
All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy etoposide and cisplatin amp carboplatin with Adebrelimab Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years
Chemoimmunotherapy Etoposide 80-100mgm2 day 1 2 3 and cisplatin 75-80mgm2 day 1 amp carboplatin AUC 5 day 1 and Adebrelimab 1200mg day 1 q3w totally 4 to 6 cycles
Immunotherapy maintenance Adebrelimab 1200mg q3w to 2 year or disease progression amp untolerated toxicity
Response evaluation After 4 to 6 cycles of chemoimmunotherapy patients would undertake response evaluation according to RECIST criteria These patients who were evaluated as partial response and stable disease could be included into the study and receive randomization
Radiotherapy to residual lesions Patients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions All residual lesions would be irradiated in a hypofractionated manner Radiotherapy should be completed in two weeks The suggested dose fraction for different lesion was as follows
Thoracic lesion 40Gy10f Cranial lesion Hippocamps-sparing whole brain irradiation of 30Gy10f with or without simultaneous integrated lesion boost of 40Gy10f Hepatic or adrenal lesion 40Gy10f Osseous lesion 30Gy10f or 40Gy10f Dose constraint to organs at risk could be referred to QUANTEC criteria 30Gy10f and Timmermans sheet 40Gy10f 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None