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A multicenter randomized phase III trial to compare weekly usage with triple weekly usage of paclitaxel concurrent with radiotherapy for patients with locally advanced non-small cell lung cancer

A multicenter randomized phase III trial to compare weekly usage with triple weekly usage of paclitaxel concurrent with radiotherapy for patients with locally advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000786
Enrollment
Unknown
Registered
2010-02-07
Start date
2007-06-01
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

Locally advanced non-small cell lung cancer

Interventions

1:The concurrent chemotherapy consisted of paclitaxel 15mg/m2, three times a week, 6 weeks in total.
2:The concurrent chemotherapy consisted of paclitaxel 45mg/m2, once weekly, 6 weeks in total.

Sponsors

Peking University School of Oncology, Beijing Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed unresectable stage IIIA or stage IIIB non-small cell lung; 2. At least 1 bidimensionally or unidimensionally measurable lesion less than 8cm; 3. Age: 18-75 years old, no more than 10% weight loss within past 6 months, life expectancy >12 months and tolerent radiation; 4. The ECOG 0-1; 5. No main organ function disable, Leucocyte>= 4000/uL, a neutrophil count>=1500/uL, PLT >=10000/uL, hemoglobin>=10g/dL, CR=1.5 L and >50% upper limit of normal; 6. No chest RT history and no other treatment for cancer in the last month.Patients who received induction chemotherapy 8cm); 7. Patients shoud understand and sign the Informed consent.

Exclusion criteria

Exclusion criteria: 1. Carcinoid tumors and small cell lung cancer; 2. Patients who received induction chemotherapy >4 cycle. Patients are receiving other anti-cancer therapy, and pregnant and lactating women; 3. Patients with a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma; 4. Active infection, uncontrolled diabetes, prior allergic reaction to paclitaxel; 5. Inadequent liver and renal function; 6. Other serious disease, for example myocardial infarction; 7. Uncontrolable madman psychopath; 8. Investigator consider inappropriate patients for the study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS);PFS, 2 and 5 year OS, MS;Median survival (MS);The 2 and 5-year overall survival (OS);

Secondary

MeasureTime frame
Response rate and toxicity;

Countries

China

Contacts

Public ContactGuangying Zhu
zgypu@yahoo.com.cn+86 010 88196120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 8, 2026