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

NCT04654520 | Unknown

• 1 other identifier: Ⅳ-NSCLC-OCTV
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy; Nonsmall Cell Lung Cancer, Stage IV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival (OS)

  Up to 5 years

• Progression-free survival (PFS)

  Up to 5 years

• Adverse events (toxicities)

  Up to 5 years

Study Arms (2)

Drug therapy combined with radiotherapy for primary tumor omitted CTV

EXPERIMENTAL

* 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

Drug therapy combined with radiotherapy for primary tumor with CTV

NO INTERVENTION

* 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.

Interventions

Drug therapy concurrent radiotherapy for primary tumor omitted CTV OTHER

Thoracic intensity modulated radiotherapy for primary tumor omitted CTV+Chemotherapy or Targeted drug therapy

Drug therapy combined with radiotherapy for primary tumor omitted CTV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guizhou Medical University: lead

Study Sites (1)

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bing Lu, Bachelor

  Affiliated Hospital of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Lu, Bachelor

CONTACT

13809432527; lbgymaaaa@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 4, 2020
• Study Start: December 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 31, 2022
• Last Updated: December 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)