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Phase II randomized controlled trial for standard radiotherapy and stratified radiotherapy for locally advanced non-small cell lung cancer

Phase II randomized controlled trial for standard radiotherapy and stratified radiotherapy for locally advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020598
Enrollment
Unknown
Registered
2019-01-09
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-01-14

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

A:Standard radiotherapy
B:Stratified radiotherapy

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. More than 18 years old; 2. ECOG score 0-2 points; 3. Histology or cytology confirmed as non-small cell lung cancer; 4. Various examinations confirmed to be inoperable stage II to III locally advanced non-small cell lung cancer, and the primary lesion was greater than 3 cm; 5. Life expectancy > 6 months; 6. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative and willing to use appropriate methods of contraception during the trial and within 8 weeks of the last administration of the test drug. For men, consent must be given to the use of appropriate methods of contraception or surgical sterilization during the trial period and within 8 weeks after the last administration of the test drug; 7. Ability to follow research and follow-up procedures; 8. Subjects understand and voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Radiotherapy is not possible due to severe comorbidities; 2. Radiotherapy has been performed on the site in need of treatment; 3. There is a distant metastasis, there is a malignant chest or pericardial effusion; 5. No amount can be added to the tumor; 7. Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease); 8. Patients who do not receive oral administration, require intravenous high-energy nutrition, have previously had an effect of absorption, or have active gastrointestinal ulcers; 9. Pregnant or lactating women; 10. The patient's main organ function is abnormal, that is, the following criteria are met: The granulocyte count is less than 1.5*109/L, the platelet count is less than 100*109/L; the serum bilirubin is 1.5 times larger than the upper limit of normal, AST and ALT are more than twice the upper limit of normal, and if there is liver metastasis, higher than 5 times of normal. Upper limit; serum creatinine is greater than 1.5 times the upper limit of normal, or creatinine clearance is less than 50 ml/min.

Design outcomes

Primary

MeasureTime frame
progression-free survival;disease control rate;objective response rate;

Secondary

MeasureTime frame
overall survival;the acute toxicity;the late toxicity;

Countries

China

Contacts

Public ContactJiancheng Li

Fujian Cancer Hospital

jianchengli6@126.com+86 13906900190

Outcome results

None listed

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