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Phase I Study to Determine MTD of Docetaxel and Cisplatin with Concurrent Radiation Therapy for Stage III Non-Small Cell Lung Cancer

Concurrent docetaxel and cisplatin with radiotherapy for LANSCLC ofStage I study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000775
Enrollment
Unknown
Registered
2010-02-05
Start date
2006-10-23
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

lung cancer

Interventions

1:concurrent chemotherapy consisted of Docetaxel 56 mg/m2 and Cisplatin 56 mg/m2, on day 1 and day 2, repeated every three weeks for a total of six weeks
2:concurrent chemotherapy consisted of Docetaxel 60 mg/m2 and Cisplatin 60 mg/m2, on day 1 and day 2, repeated every three weeks for a total of six weeks
3:concurrent chemotherapy consisted of Docetaxel 64 mg/m2 and Cisplatin 64 mg/m2, on day 1 and day 2, repeated every three weeks for a total of six weeks

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 70 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: 18-70 years old, no more than 10% weight loss within past 6 months, life expectancy >12 months and tolerent radiation; 4. No chest RT history and no other treatment for cancer in the last month; 5. The ECOG 0-1; 6. 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; 8. Patients shoud understand and sign the Informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients are receiving other anti-cancer therapy, and pregnant and lactating women; 2. Patients with a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma; 3. Any chemotherapy contraindications such as active infection, uncontrolled diabetes, prior allergic reaction to docetaxel and other serious disease, for example myocardial infarction. 4. Uncontrolable madman psychopath; 5. Investigator consider inappropriate patients for the study.

Design outcomes

Primary

MeasureTime frame
Response rate and toxicity;

Countries

China

Contacts

Public Contactzhu guangying
zgypu@yahoo.com.cn+86 010 88196120

Outcome results

None listed

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