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Randomized control trial of comprehensive therapy for special stage IIIB non-small-cell lung cancer

Randomized control trial of comprehensive therapy for special stage IIIB non-small-cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-07000042
Enrollment
Unknown
Registered
2007-12-07
Start date
2007-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

special stage IIIB non-small-cell lung cancer

Interventions

Control group:Traditional concurrent chemotherapy plus radiotherapy
Experimental group:Supraclavicaular lymph nodes dissection

Sponsors

Cancer Hospital Affiliated to Tianjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Special stage IIIB non-small-cell lung cancer diagnosed by histology and pathology/cytology on first- time treatment; definition of special stage IIIb: T: T1,T2,T3; N: supraclavicular lymph nodes metastasis, excluding other N3; M: M0; 2. At least one focus with two diameters measurable, spiral CT scanning more greater than 10 mm; 3. In good physical condition: ECOG score 0-2 points; 4. Predicted survival longer than 3 months; 5. Age over 18 years, non-limited gender; 6. In accordance with the clinical application and basic request including normal peripheric hemogram, normal function of heart, liver and kidney, essentially normal ECG and without unhealing trauma; Laboratory index must meet with following requests: Peripheric hemogram: WBC more than 4.0*10^9/L, PLT more than 80*10^9/L, Hb more than 90g/L; Renal function: Cr<=2.0*UNL (normal upper limit); Liver function: BIL less than 2.0*UNL, ALT/AST less than 5.0*UNL; 7. Participated with free will and good compliance, easy to cooperate in trial observation and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Other stage IIIB non-small-cell lung cancer unqualified in this trial; 2. Pregnant or breast-feeding women or female in reproductive stage without birth control; 3. Severe acute infection out of control; purulent chronic infection with chronic nonunion wound; 4. Complicated with severe heart disease including congestive heart failure, uncontrolled fatal arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension; 5. With uncontrolled neural and mental disorder and poor compliance, unable to cooperate and recount the therapeutic response; primary encephaloma or uncontrolled metastatic tumor of the central nervous system with evident intracranial hypertension or neuropsychiatric symptoms; 6. Participated in other clinical trial at the same time; 7. Other inappropriate conditions.

Design outcomes

Primary

MeasureTime frame
Survival;

Secondary

MeasureTime frame
Quality of life;Cost-Benefit analysis;

Countries

China

Contacts

Public ContactZhanyu Pan; Changli Wang
tjpanzhanyu@medmail.com.cn+86 022 13820583299

Outcome results

None listed

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