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Recombine Endostatin in alliance with neoadjuvant chemotherapy followed by concurrent chemoradiation in locoregionally advanced nasopharyngeal carcinoma

Recombine Endostatin alliance with neoadjuvant chemotherapy followed by concurrent chemoradiation in locoregionally advanced nasopharyngeal carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-12002394
Enrollment
Unknown
Registered
2012-07-08
Start date
2011-12-01
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

nasopharyngeal carcinoma

Interventions

1:docetaxel 75mg/m2 iv in day 1 +Cisplatin 75mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles
2:Cisplatin 75mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles

Sponsors

Guiyang Medical College affiliated Hospital of oncology (Cancer Hospital of Guizhou province)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary and sign the informed consent form; 2. Age 18-70 years old, male or female; 3. histologically proved to be keratinizing carcinoma or non-keratinizing carcinoma; 4. nasopharyngeal darcinoma 2010 UICC staging III-IV A, IV B; 5. measurable Primary tumors; 6. karnofsky score>=70; ECOG>=2; 7. Expected survival>=6 months; 8. Women in productive age should guarantee use contraceptives during study period; 9. Hemoglobin (HGB) >=100g/L, white blood cell (WBC) >=4*10^9/L, Platelet (PLT)>=100*10^9/L. (or white blood cell and platelet not less than our hospital's Normal lowest index); 10. liver function: Alanine amino transferase (ALAT), aspartate aminotransferase (ASAT) <1.5 times the upper limit of the normal index; total bilirubin<1.5*ULN; 11. liver function: serum creatinine<1.5*ULN; 12. do not have severe complication, such as Hypertensio, Diabetes and History of mental illness; 13. this treatment is First treatment process (do not have a H&N Radiation history; do not have a history of Concurrent chemoradiotherapy; do not have chemotherapy history in 3 months.

Exclusion criteria

Exclusion criteria: 1. Have a distant metastasis; 2. The primary focal tumors or lymph node already had a surgical treatment (except for biopsy); 3. Already had a radiotherapy for primary focal or lymph node; 4. Patient who received the the epidermal growth factor targeted therapy; 5. The primary focal had received chemoradiotherapy or immunotherapy; 6. Patient who suffered from other malignant tumor (except for cured basal cell carcinoma or carcinoma in situ of cervix); 7. Subject who have taken other drug test in 1 month; 8. Peripheral Neuropathy> level; 9. pregnant woman or Lactating Women and Women in productive age who refuse take contraception in observation period; 10. subject with a severe allergic history or idiosyncratic; 11. subject with severe pulmonary and cardiopathic disease history; 12. refuse or incapable to sign the informed consent form of participating this trial; 13. drug abuse or alcohol addicted; 14. subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
Acute side effects;Clinical response rate;

Secondary

MeasureTime frame
overall survival;progression free survival;

Countries

China

Contacts

Public ContactJing Feng
jinf8865@yahoo.com.cn+86 13985124806

Outcome results

None listed

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