Clinical trial · Interventional
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
NCT04654520CI-TRIAL-00048628unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonsmall Cell Lung Cancer, Stage IV | Lung Non-Small Cell Carcinoma | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug therapy concurrent radiotherapy for primary tumor omitted CTV | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Drug therapy combined with radiotherapy for primary tumor omitted CTV
- 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.
- interventionNames
- Other: Drug therapy concurrent radiotherapy for primary tumor omitted CTV
- type
- NO_INTERVENTION
- label
- Drug therapy combined with radiotherapy for primary tumor with CTV
- 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.
Primary outcomes (1)
- measure
- Local regional progression-free survival(LRPFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.