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Recombine Endostatin With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Advanced Nasopharynx Cancer

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ClinicalTrials.gov Identifier: NCT01689558
Recruitment Status : Unknown
Verified March 2013 by Jin Feng, Cancer Hospital of Guizhou Province.
Recruitment status was:  Recruiting
First Posted : September 21, 2012
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
Jin Feng, Cancer Hospital of Guizhou Province

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.

Condition or disease Intervention/treatment Phase
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, Drug: Recombine Endostatin Phase 2 Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
Study Start Date : December 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Recombine Endostatin
Induction chemotherapy: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 Synchronous chemotherapy: cisplatin 80 mg/m2 points d1-2, 21days for a cycle, 2 cycles, the same day in radiation therapy. Synchronous chemotherapy in chemotherapy day one recombinant human vascular endothelial inhibin 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment
Drug: Recombine Endostatin
Recombine Endostatin is involved in the arm of Recombine Endostatin .Recombinant human vascular endothelial inhibin 7.5 mg/M2 / d dose add 250 ml of physiological saline, dilute in new adjuvant chemotherapy began to 8-21 days intravenous drip, at least 1 hour, a total of 1 cycle; The chemoradiation in cisplatin chemotherapy first day grace degrees 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment
Other Name: recombinant human vascular endothelial inhibin




Primary Outcome Measures :
  1. main objective [ Time Frame: at the end of the Radiation ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689558


Contacts
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Contact: Feng Jin, Professor +86 13985124806 jinf8865@gmail.com

Locations
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China, Guizhou
Cancer Hospital of Guizhou province Recruiting
Guiyang, Guizhou, China, 550002
Contact: Feng Jin, Professor    +86 13985124806    jinf8865@gmail.com   
Principal Investigator: Feng Jin, Professor         
Sponsors and Collaborators
Jin Feng
Investigators
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Principal Investigator: Jin Feng, Professor Cancer Hospital of Guizhou Province

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Responsible Party: Jin Feng, Professor, Cancer Hospital of Guizhou Province
ClinicalTrials.gov Identifier: NCT01689558     History of Changes
Other Study ID Numbers: 20111220
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013
Keywords provided by Jin Feng, Cancer Hospital of Guizhou Province:
nasopharynx cancer,Image department of nose pharynx ministry
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors