Clinical trial NCT01689558: Recombine Endostatin With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Advanced Nasopharynx Cancer
Official title: Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: 1、Enough Cases
2、Elekta Precise 1343 Digital Control Electron Linear Accelerator
Can Undertake Nasopharyngeal Carcinoma Specimens in the Materia，
Image Department of Nose Pharynx Ministry MRI Dynamic Testing,
Keywords: nasopharynx cancer,Image department of nose pharynx ministry
Lead sponsor: Cancer Hospital of Guizhou Province
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1) Observe and compare the curative effect of endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma; 2) Evaluate the security and tolerability in endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma.

Detailed description: 1. experimental group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles;followed by concurrent chemoradiation(Cisplatin 80mg/m2 iv in day 1,21 +human endostatin 7.5mg/m2 iv in day 1-14 and Concurrent Intensity-modulated radiation therapy)
2. Control group:group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 and three weeks repeat and total two cycles;followed by concurrent chemoradiation(Cisplatin 80mg/m2 iv in day 1,21 and Concurrent Intensity-modulated radiation therapy)

Eligibility 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) ≥4×109 /L，Platelet（PLT）≥100×109 /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:

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.

Primary outcomes:
measure: main objective
timeFrame: at the end of the Radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou province
state: Guizhou
Study officials:
affiliation: Cancer Hospital of Guizhou Province
name: Jin Feng, Professor
role: PRINCIPAL_INVESTIGATOR
References: