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Trial Title:
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy
NCT ID:
NCT05552846
Condition:
Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Conditions: Keywords:
thoradic radiotherapy
immune checkpoint inhibitors
chemo-immunotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
thoracic radiotherapy
Description:
Four courses of carboplatin/etoposide/anti-PD-1/PD-L1 every 3 weeks All the enrolled
patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST
v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1.
Then, thoracic radiotherapy of 45 Gy/15 fractions. PD-1/PD-L1 maintenance therapy
concurrently and after thoracic radiotherapy at least more than 6 months, or until
intolerable toxicity, progressive disease leading to a need for other treatment, or until
the patient no longer wishes to continue treatment.
Arm group label:
experimental group
Summary:
This is an open-label, single arm Phase II study designed to evaluate the efficacy and
safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with
PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy
Detailed description:
This study a single arm prospective phase II study. All the enrolled patients will be
patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6
cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those
enrolled patients would be treated with thoracic radiotherapy concurrently with
PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least
more than 6 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age between18 years and 80 years at time of study entry
2. ECOG performance status of 0 or 1
3. Body weight >30 kg
4. Adequate bone marrow, liver and kidney function
5. Life expectancy of at least 3 months
6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45
Gy/15 fractions
7. Histologic or cytologic confirmation of small cell lung cancer
8. Stage III-IV disease (TNM v8)
9. Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30
% of predicted value
10. Patients with brain metastases are eligible provided they are asymptomatic or
treated and stable on steroids and/or anticonvulsants prior to the start of
treatment -
Exclusion Criteria:
1. Previous chemo-, immuno- or radiotherapy for SCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency,
hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Yifeng Wang
Phone:
+862164370045
Email:
qwx12055@rjh.com.cn
Contact backup:
Last name:
Yi Xiang, Dr.
Contact backup:
Last name:
Shengguang Zhao, Dr
Start date:
January 30, 2021
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05552846
