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A phase II randomized, open labled clinical trial to compare the efficacy of palliative thoracic radiotherapy with docetaxel maintenance therapy after first line gemcitabine plus platinum chemotherapy in patients with advanced central type squamous cell caranoma of the lung

A phase II randomized, open labled clinical trial to compare the efficacy of palliative thoracic radiotherapy with docetaxel maintenance therapy after first line gemcitabine plus platinum chemotherapy in patients with advanced central type squamous cell caranoma of the lung

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006594
Enrollment
Unknown
Registered
2015-06-15
Start date
2015-07-01
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

Lung cancer

Interventions

Palliative radiotherapy:Palliative thoracic radiotherapy
Maintenance therapy:Docetaxel maintenance therapy

Sponsors

Shanghai Pulmonary Hospital, Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histological diagnosis of squamous cell carcinoma; 2. Advanced stage (M1a or M1b); Number of distant metastasis <3; 3. Patients received first-line GP/GC (gemcitabine plus cisplatin or carboplatin) chemotherapy, after 4 courses of treatment the efficacy is CR, PR or SD; 4. There must be measurable lesions according to the RECIST standards; 5. The imaging features must be central type with a location in the segment or above; 6. ECOG physical status score of 0-2; 7. With a life expectancy of 12 weeks; 8. Patients with good compliance and geographic proximity to ensure adequate follow-up; 9. Including the following adequate organ function: Bone marrow: absolute neutrophil count (ANC) = 1.5*10^9/L; 100*10^9/L = 9g/L. = platelet, hemoglobin Liver function: bilirubin is less than or equal to 1.5 times the normal value of the upper limit of normal (ULN); alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate amino shift enzyme (AST) is less than or equal to three times the ULN (such as liver metastasis, AP, ALT, AST is less than or equal to five times the ULN). Renal function: creatinine clearance rate was higher than 45mL/min (standard Cockcroft-Gault formula); 9. Male or female, aged 18 years or older; 10. Male and female with fertility must use effective contraception (e.g., intrauterine devices, oral contraceptives, or condoms); 11. Informed consent signed; 12. Asymptomatic brain metastasis without spinal cord compression; 13. Weight loss less than 10% in 6 months.

Exclusion criteria

Exclusion criteria: 1. With symptoms of cerebral metastasis or spinal cord compression, the number of metastatic more than 3; 2. Receive other anti-tumor therapy simultaneously; 3. With active infection; 4. according to the researcher's judgment, the patient can not complete the research safely; 5. Pregnant or breastfeeding; 6. Have obvious neurological or psychiatric history, including epilepsy or dementia; 7. Have other malignant tumor, basal cell carcinoma, or carcinoma of the cervix, except in situ of the tumor, within 5 years; 8. Uncontrollable pleural effusion and ascites; 9. Weight loss more than 10% in 6 months; 10. Disease progression after first-line chemotherapy; 11. Known to docetaxel and auxiliary agent allergy; 12. Receive more than 1 cycle of first-line chemotherapy drug therapy; 13. Once accepted chest radiotherapy.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Progression free survival;Overall response rate;Duration of the respons;Safety;Quality of life;

Countries

China

Contacts

Public ContactZhou Caicun
caicunzhoudr@163.com+86 13301825532

Outcome results

None listed

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