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

A Randomized Study of Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Stage Ⅳ NSCLC

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.

Study Overview

• Status: Unknown
• Conditions: Radiotherapy; Nonsmall Cell Lung Cancer, Stage IV
• Intervention / Treatment: Other: Drug therapy concurrent radiotherapy for primary tumor omitted CTV

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.

• Study Type: Interventional
• Enrollment (Anticipated): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550001
      • Affiliated Hospital of Guizhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug therapy combined with radiotherapy for primary tumor omitted CTV; 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.	Other: Drug therapy concurrent radiotherapy for primary tumor omitted CTV; Thoracic intensity modulated radiotherapy for primary tumor omitted CTV+Chemotherapy or Targeted drug therapy
No Intervention: Drug therapy combined with radiotherapy for primary tumor with CTV; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years
Overall survival (OS)	Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.	Up to 5 years
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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Guizhou Medical University
• Investigators: Principal Investigator: Bing Lu, Bachelor, Affiliated Hospital of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Ⅳ-NSCLC-OCTV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No