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Hybrid of SBRT and Conventional Fractionated IMRT technique in the treatment of locally advanced non-small cell lung cancer: A phase II trial

Hybrid of SBRT and Conventional Fractionated IMRT technique in the treatment of locally advanced non-small cell lung cancer: A phase II trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017591
Enrollment
Unknown
Registered
2018-08-05
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Case series:Hybrid SBRT-IMRT

Sponsors

Fujian Provincial Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged = 18 years; 2. ECOG performance status of 0–2; 3. Patients must have histologically or cytologically proven non-small cell lung cancer.Patients must be clinical AJCC stage T1-2, N2-3, M0 (AJCC, 8th ed.) with non-operable disease; nonoperable disease will be determined by thoracic surgeon, radiation oncologist and a medical oncologist, or pulmonologist; 4. Patients with clinical AJCC stage T1-2, N1, M0 (AJCC, 8th edition) who are medically inoperable or refuse surgery are eligible; 5. Patients with tumors invade the chest wall or ipsilateral pulmonary nodules (T3, or T4) are eligible if SBRT is feasible; 6. Patients with clinical AJCC stage T3-4, N2-3, M0 (AJCC, 8th edition) are eligible if the primary tumors are successfully downstaged by induction chemotherapy or targeted therapy; 7. Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study; 8. The patient must provide study-specific informed consent prior to study entry.

Exclusion criteria

Exclusion criteria: 1. Patients with any component of small cell lung carcinoma are excluded; 2. Patients with evidence of a malignant pleural or pericardial effusion are excluded; 3. The treatment plan cannot meet the dose constraints of the organs at risk for Hybrid SBRT-IMRT; 4. Prior invasive malignancy unless disease free for a minimum of 3 years; 5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. 6. Severe, active co-morbidity such as unstable angina and/or congestive heart failure, transmural myocardial infarction, acute bacterial or fungal infection, Chronic Obstructive Pulmonary Disease, hepatic insufficiency and Acquired Immune Deficiency Syndrome (AIDS); 7. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.

Design outcomes

Primary

MeasureTime frame
Local Control Rate;Toxicity;Regional Control Rate;

Secondary

MeasureTime frame
Overall Survival;

Countries

China

Contacts

Public ContactBuhong Zheng

Fujian Provincial Tumor Hospital

zhengbuhong@hotmail.com+86 13655031969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026