Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer

September 16, 2021 updated by: Luhua Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
        • Contact:
          • wang Luhua, MD
        • Principal Investigator:
          • Wang Luhua, MD
        • Principal Investigator:
          • Bi Nan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
Overall survival (OS)
Time Frame: 1 year
The time from treatment to death from any cause
1 year
Adverse events
Time Frame: 1 year
The incidence and severity of adverse events related to treatments
1 year
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
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Director: Bi Nan, MD, Cancer Hospital, CAMS and PUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (ACTUAL)

July 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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