PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Prophylactic cranial irradiation

Thoracic radiotherapy

Chemotherapy

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer Limited Stage focused on measuring prophylactic cranial irradiation, brain MRI follow-up, prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically/cytologically proven diagnosis of SCLC. Age ≥ 18 years. Karnofsky performance status ( KPS) ≥80. The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter ≥ 1cm or PET-CT shows increased metabolism with SUV≥2.5, or proved by mediastinoscopy/EBUS/TBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC/UICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis. Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers). Good follow-up compliance; Fully understand this study, and voluntarily sign the informed consent form. Exclusion Criteria: Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ. Patients who have received radical surgery (excluding biopsy). Patients with psychiatric history, pregnancy and lactation. Uncontrolled diabetes, hypertension, severe active infection. Patients with chronic diseases of central nervous system. Patients with contraindications of brain MRI examination. Other situations deemed unsuitable by the doctor in charge.

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm

Study arm

Arm Description

Patients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up.

Patients who are randomized to study arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive regular brain MRI follow-up alone.

Outcomes

Primary Outcome Measures

2-year brain metastasis-free survival estimated with kaplan-Meier method

To test with a one-sided significance of 5% whether for the treatment of limited-stage SCLC patients, brain MRI follow-up alone is non-inferior in terms of 2-year brain metastasis-free survival compared to PCI and brain MRI follow-up. Participants were monitored for up to 2 years. The brain metastasis-free survival time is defined as the time between the date of the first treatment until the date of first documented diagnosis of brain metastasis or the date of death from any cause.

Secondary Outcome Measures

2-year overall survival estimated with kaplan-Meier method

To compare 2-year overall survival between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up, with kaplan-Meier estimates. Participants were monitored for up to 2 years. The overall survival time is defined as the time between the date of the first treatment until the date of death from any cause.

Intra-cranial progressive patterns

To compare the intra-cranial progressive patterns between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up within 2 years. Intra-cranial progression is evaluated via the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In this study, Intra-cranial progressive disease is defined as the new lesions developed in the brain.

Full Information

NCT ID

NCT05651802

First Posted

December 2, 2022

Last Updated

May 23, 2023

Sponsor

Zhejiang Cancer Hospital

Collaborators

Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT05651802

Brief Title

PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients

Official Title

Prophylactic Cranial Irradiation and Brain MRI Follow-up Versus Brain MRI Follow-up Alone in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Complete Remission After Definitive Radio-chemotherapy: a Prospective Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Cancer Hospital

Collaborators

Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. However, the value of PCI is being challenged in the era when MRI examination of brain has been popularized. The goal of this clinical study is to compare PCI and regular brain MRI follow-up (control arm) and regular brain MRI follow-up alone (study arm) in patients with limited-stage SCLC who have received definitive radiotherapy and chemotherapy and acheived complete remission (CR) of tumor. The main questions to answer are: Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group. The difference of 2-year overall survival rate between the control group and the study group. Whether the patients in the study group have better overall quality of life than those in the control group. Participants will randomly receive either PCI and regular brain MRI follow-up or regular brain MRI follow-up alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer Limited Stage

Keywords

prophylactic cranial irradiation, brain MRI follow-up, prognosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

Patients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up.

Arm Title

Study arm

Arm Type

Experimental

Arm Description

Patients who are randomized to study arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive regular brain MRI follow-up alone.

Intervention Type

Radiation

Intervention Name(s)

Prophylactic cranial irradiation

Intervention Description

Prophylactic cranial irradiation (PCI) is actually a habitual statement. It is a technique used to eliminate tiny metastatic lesions that have already existed in the brain, but can not be found by brain MRI and other inspection methods.

Intervention Type

Radiation

Intervention Name(s)

Thoracic radiotherapy

Intervention Description

Thoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Chemotherapy is the abbreviation of chemical drug therapy. It is a treatment method that uses chemical drugs to prevent the proliferation, invasion and metastasis of cancer cells, and finally kill cancer cells.

Primary Outcome Measure Information:

Title

2-year brain metastasis-free survival estimated with kaplan-Meier method

Description

To test with a one-sided significance of 5% whether for the treatment of limited-stage SCLC patients, brain MRI follow-up alone is non-inferior in terms of 2-year brain metastasis-free survival compared to PCI and brain MRI follow-up. Participants were monitored for up to 2 years. The brain metastasis-free survival time is defined as the time between the date of the first treatment until the date of first documented diagnosis of brain metastasis or the date of death from any cause.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

2-year overall survival estimated with kaplan-Meier method

Description

To compare 2-year overall survival between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up, with kaplan-Meier estimates. Participants were monitored for up to 2 years. The overall survival time is defined as the time between the date of the first treatment until the date of death from any cause.

Time Frame

Up to 2 years

Title

Intra-cranial progressive patterns

Description

To compare the intra-cranial progressive patterns between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up within 2 years. Intra-cranial progression is evaluated via the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In this study, Intra-cranial progressive disease is defined as the new lesions developed in the brain.

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histologically/cytologically proven diagnosis of SCLC. Age ≥ 18 years. Karnofsky performance status ( KPS) ≥80. The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter ≥ 1cm or PET-CT shows increased metabolism with SUV≥2.5, or proved by mediastinoscopy/EBUS/TBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC/UICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis. Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers). Good follow-up compliance; Fully understand this study, and voluntarily sign the informed consent form. Exclusion Criteria: Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ. Patients who have received radical surgery (excluding biopsy). Patients with psychiatric history, pregnancy and lactation. Uncontrolled diabetes, hypertension, severe active infection. Patients with chronic diseases of central nervous system. Patients with contraindications of brain MRI examination. Other situations deemed unsuitable by the doctor in charge.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao Hu, MD, PhD

Phone

+86-571-88128172

Email

huxiao@zjcc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao Hu, MD, PhD

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejaing

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiao Hu, MD. PhD.

Phone

+86-571-88128172

Email

huxiao@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

No

Small Cell Lung Cancer Limited Stage

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial