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Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04947774
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Luhua Wang, Chinese Academy of Medical Sciences

Brief Summary:
The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.

Condition or disease Intervention/treatment
Extensive-stage Small-cell Lung Cancer Radiation: Prophylactic Cranial Irradiation

Detailed Description:

This study is a prospective trial. This study included ES-SCLC patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality.

The primary endpoint is progression-free survival in the brain.The secondary endpoints includes OS, PFS. The indicators for evaluating safety are the incidence and severity of adverse events.The exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood TMB.

The trial was designed by the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College. The hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive SCLC combined with chemotherapy and immunotherapy.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
prophylactic cranial irradiation group
The extensive-stage SCLC patients will receive prophylactic cranial irradiation after standard first-line chemotherapy combined with immunotherapy, until disease progression or death.
Radiation: Prophylactic Cranial Irradiation
The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death
Other Name: Immunotherapy

Observation group
Patients with extensive-stage SCLC do not receive preventive craniocerebral irradiation after standard first-line chemotherapy combined with immunotherapy until the disease progresses or death.



Primary Outcome Measures :
  1. Progression-free survival in the brain [ Time Frame: 1 year ]
    The length of time during and after treatment for a disease in which the patient lives with the disease but the intracranial lesions do not worsen


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 1 year ]
    The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse

  2. Overall survival (OS) [ Time Frame: 1 year ]
    The time from treatment to death from any cause

  3. Adverse events [ Time Frame: 1 year ]
    The incidence and severity of adverse events related to treatments

  4. The cognitive function of the patient [ Time Frame: 1 year ]
    Use the Montreal Cognitive Screening Scale (MoCA) to score, the total score is 30 points, ≥26 points are normal


Other Outcome Measures:
  1. Exploratory end point including biomarkers [ Time Frame: 1 year ]
    To explore the correlation of PD-L1 expression in tumor tissue , TCR, ctDNA in peripheral blood and efficacy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
It is planned to enroll patients who have completed and response to first-line chemotherapy combined with immunotherapy, Later immunotherapy treatments are open
Criteria

Inclusion Criteria:

  • Sign written informed consent;
  • With extensive small cell lung cancer;
  • Previously received first-line standard chemotherapy, with treatment response of CR or PR;
  • Can tolerate the radiotherapy process;
  • Be over 18 years old
  • Life expectancy ≥ 12 weeks;
  • With the Eastern Cancer Cooperative Group (ECOG) score 0-1
  • After the systemic treatment was received, there was no brain metastasis on MR before brain preventive irradiation.

Exclusion Criteria:

  • Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis;
  • Pregnancy or breastfeeding;
  • Any other conclusive medical, psychiatric and/or social reasons determined by the researcher;
  • Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study;
  • Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04947774


Contacts
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Contact: Liu Wen-Yang, MD 8613810753633 liuwenyang26@163.com

Locations
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China, Beijing
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: wang Luhua, MD         
Principal Investigator: Wang Luhua, MD         
Principal Investigator: Bi Nan, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Director: Bi Nan, MD Cancer Hospital, CAMS and PUMC
Publications:

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Responsible Party: Luhua Wang, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04947774    
Other Study ID Numbers: NCC2622
First Posted: July 1, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luhua Wang, Chinese Academy of Medical Sciences:
Small-cell Lung Cancer
Radiation:prophylactic cranial irradiation
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms