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Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
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,

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Trial Information

Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma


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)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Outcome Measure:

main objective

Outcome Description:

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 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.

Outcome Time Frame:

at the end of the Radiation

Safety Issue:

Yes

Principal Investigator

Jin Feng, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital of Guizhou Province

Authority:

China: Ethics Committee

Study ID:

20111220

NCT ID:

NCT01689558

Start Date:

December 2011

Completion Date:

January 2017

Related Keywords:

  • 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,
  • nasopharynx cancer,Image department of nose pharynx ministry
  • Carcinoma
  • Nasopharyngeal Neoplasms

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