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A Randomized Study of Primary Tumor Radiotherapy for Patients With Stage Ⅳ NSCLC

Primary Purpose

Radiotherapy, Nonsmall Cell Lung Cancer, Stage IV

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug therapy concurrent radiotherapy for primary tumor omitted CTV
Sponsored by
Guizhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with pathological or cytological diagnosis, stage IV [UICC 2017 staging eighth edition] NSCLC patients;
  • initial treatment (previously did not receive any treatment), it is recommended to complete the detection of driver genes (EGFR / ALK / ROS1) (tissue, blood);
  • Age 18 to 80 years old, physical status score ECOG 0 to 2 or KPS ≥ 70 (see Annex 2); Metastatic lesions in the distant area: conscious when brain metastasis; the number of metastatic lesions in the lung does not affect lung function and may be treated with primary and/or partial metastases;
  • no radiotherapy, targeted drug therapy and chemotherapy contraindications;
  • primary tumor radiotherapy requires IMRT technology;
  • Plan the design to give the primary tumor prescription dose (DTGTV) under the damage control threshold criteria;
  • The planned dose includes 100% GTV, 90% of the prescribed dose includes 98%~100% of PTV [planned target dose (DTPTV)]; normal lung (full lung volume minus GTV volume) V20 ≤ 32%, MLD≤20Gy;
  • metastatic tumor radiotherapy is a three-dimensional radiotherapy technique (IMRT/SRT/SBRT/VMAT, etc.), and large-segment radiotherapy.
  • Subjects have no major organ dysfunction, or laboratory test indicators must meet the following requirements: Hematology: normal range according to laboratory standards; cardiac function: normal range; liver function: normal range; renal function: normal range Lung function: FEV1>50%, impaired light-moderate lung function.
  • Informed consent (radiation, medication) before treatment;
  • The patient has good compliance with the treatment and follow-up received.

Exclusion Criteria:

  • Patients who do not meet the pathological type, stage, and survival status of the inclusion criteria;
  • patients with malignant pericardial effusion; Diffuse liver metastasis, intrapulmonary metastasis and has seriously affected patients with liver and lung function;
  • Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months; clinically diagnosed heart valve disease;
  • Active period of disease caused by bacteria, fungi or viruses; mental disorders; impaired severe lung function;
  • pregnant, lactating patients;
  • Patients with a history of other active malignancies other than small cell lung cancer before entering the group; non-melanoma skin basal cell carcinoma, in situ cervical cancer, and cured early prostate cancer;
  • Patients with allergies and no known alternatives to known or suspected drugs in any study;
  • Patients with poor compliance;
  • Researchers believe that it is not appropriate to participate in this test.

Sites / Locations

  • Affiliated Hospital of Guizhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Drug therapy combined with radiotherapy for primary tumor omitted CTV

Drug therapy combined with radiotherapy for primary tumor with CTV

Arm Description

IMRT (omitted CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy. IMRT (omitted CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation.

IMRT (with CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy. IMRT ((with CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation.

Outcomes

Primary Outcome Measures

Local regional progression-free survival（LRPFS）
LRPFS is defined as the duration of time from start of treatment to time of progression or recurrence, whichever occurs first.The target lesions is only for primary tumor and regional positive lymph nodes.

Secondary Outcome Measures

Overall survival (OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Progression-free survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Adverse events (toxicities)
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Full Information

First Posted
November 29, 2020
Last Updated
December 3, 2020
Sponsor
Guizhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04654520
Brief Title
A Randomized Study of Primary Tumor Radiotherapy for Patients With Stage Ⅳ NSCLC
Official Title
A Randomized Study of Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Stage Ⅳ NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this randomized study is to investigate local tumor control, survival outcomes,and complications on patients of stage Ⅳ non small-cell lung cancer ,whom based on medication with concurrent primary radiotherapy omitting clinical tumor volume.
Detailed Description
Cancer Statistics,（2020）states that low lung cancer survival rates reflect the large proportion of patients (57%) diagnosed with metastatic disease, for which the 5-year relative survival rate is 5%.With the development of three-dimensional radiotherapy technology, the wide application of comprehensive treatment concept, and the understanding of the relationship between different metastatic state and survival of stage IV NSCLC, prospective and retrospective studies have confirmed that systemic therapy combined with primary tumor three-dimensional radiation Treatment is more conducive to improving symptoms and prolonging survival than medication alone. Some retrospective analysises of stage III NSCLC, omitting clinical target volume of primary tumor with intensity modulated radiotherapy showed no reduction in local control rate and survival time.Omitted CTV in Ⅳ NSCLC patients with primary tumor radiotherapy can make smaller target area, which could push up most of the local stage of late Ⅳ NSCLC patients with primary tumor radiation dose. Prospective studies are needed to further clarify whether omission of target areas may affect local control time, survival time, and radioactive toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy, Nonsmall Cell Lung Cancer, Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug therapy combined with radiotherapy for primary tumor omitted CTV
Arm Type
Experimental
Arm Description
IMRT (omitted CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy. IMRT (omitted CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation.
Arm Title
Drug therapy combined with radiotherapy for primary tumor with CTV
Arm Type
No Intervention
Arm Description
IMRT (with CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy. IMRT ((with CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation.
Intervention Type
Other
Intervention Name(s)
Drug therapy concurrent radiotherapy for primary tumor omitted CTV
Intervention Description
Thoracic intensity modulated radiotherapy for primary tumor omitted CTV+Chemotherapy or Targeted drug therapy
Primary Outcome Measure Information:
Title
Local regional progression-free survival（LRPFS）
Description
LRPFS is defined as the duration of time from start of treatment to time of progression or recurrence, whichever occurs first.The target lesions is only for primary tumor and regional positive lymph nodes.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Time Frame
Up to 5 years
Title
Progression-free survival (PFS)
Description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time Frame
Up to 5 years
Title
Adverse events (toxicities)
Description
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with pathological or cytological diagnosis, stage IV [UICC 2017 staging eighth edition] NSCLC patients; initial treatment (previously did not receive any treatment), it is recommended to complete the detection of driver genes (EGFR / ALK / ROS1) (tissue, blood); Age 18 to 80 years old, physical status score ECOG 0 to 2 or KPS ≥ 70 (see Annex 2); Metastatic lesions in the distant area: conscious when brain metastasis; the number of metastatic lesions in the lung does not affect lung function and may be treated with primary and/or partial metastases; no radiotherapy, targeted drug therapy and chemotherapy contraindications; primary tumor radiotherapy requires IMRT technology; Plan the design to give the primary tumor prescription dose (DTGTV) under the damage control threshold criteria; The planned dose includes 100% GTV, 90% of the prescribed dose includes 98%~100% of PTV [planned target dose (DTPTV)]; normal lung (full lung volume minus GTV volume) V20 ≤ 32%, MLD≤20Gy; metastatic tumor radiotherapy is a three-dimensional radiotherapy technique (IMRT/SRT/SBRT/VMAT, etc.), and large-segment radiotherapy. Subjects have no major organ dysfunction, or laboratory test indicators must meet the following requirements: Hematology: normal range according to laboratory standards; cardiac function: normal range; liver function: normal range; renal function: normal range Lung function: FEV1>50%, impaired light-moderate lung function. Informed consent (radiation, medication) before treatment; The patient has good compliance with the treatment and follow-up received. Exclusion Criteria: Patients who do not meet the pathological type, stage, and survival status of the inclusion criteria; patients with malignant pericardial effusion; Diffuse liver metastasis, intrapulmonary metastasis and has seriously affected patients with liver and lung function; Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months; clinically diagnosed heart valve disease; Active period of disease caused by bacteria, fungi or viruses; mental disorders; impaired severe lung function; pregnant, lactating patients; Patients with a history of other active malignancies other than small cell lung cancer before entering the group; non-melanoma skin basal cell carcinoma, in situ cervical cancer, and cured early prostate cancer; Patients with allergies and no known alternatives to known or suspected drugs in any study; Patients with poor compliance; Researchers believe that it is not appropriate to participate in this test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Lu, Bachelor
Phone
13809432527
Email
lbgymaaaa@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Lu, Bachelor
Organizational Affiliation
Affiliated Hospital of Guizhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Randomized Study of Primary Tumor Radiotherapy for Patients With Stage Ⅳ NSCLC

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