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After Induction Chemotherapy of DP Plus DDP Concurrent Radiotherapy With and Without Bevacizumab Study

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02047487
Collaborator
(none)
120
Enrollment
2
Locations
63
Duration (Months)
60
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, open controlled multicenter phase II clinical study. The SPSS statistical software estimation of sample size, selection of the initial treatment of locally advanced head and neck squamous cell carcinoma in 120 patients, such as to achieve the desired results, considering expanding the clinical, according to the proportion of 1:1 were randomly divided into two groups, all patients were taken, docetaxel + cisplatin 2 cycles of induction chemotherapy 、Concurrent chemoradiotherapy（tomotherapy+cisplatin）, The experimental group was added with AVASTIN.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Docetaxel (T), Cisplatin (P) After Induction Chemotherapy With and Without Cisplatin (P) Concurrent Radiotherapy (X) Plus Bevacizumab (B) Phase II Clinical Study
    Study Start Date :
    May 1, 2013
    Anticipated Primary Completion Date :
    Aug 1, 2014
    Anticipated Study Completion Date :
    Aug 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. ORR [three month after ratiotherapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Men and women are not limited, requirements of ECOG0-2, age 18-70 years old, pathological stage III (NCCN2012), had not received radiotherapy and chemotherapy, expected to survive more than 3 months, the routine testing, were in the normal range, signed the informed consent

    Exclusion Criteria:

    Do not meet the above criteria; allergic to docetaxel and AVASTIN, or metabolic disorders; associated with gastrointestinal bleeding, perforation and other serious diseases; severe liver disease, kidney disease, respiratory disease or unable to control diabetes, hypertension and other chronic disease; heart disease clinical symptoms; there is peripheral nervous system disorders or have obvious mental disorder and disorders of the central nervous system; active phase >CTCAE2 clinical severe infection; a history of organ transplantation (including bone marrow transplantation of autologous peripheral stem cell transplantation); pregnant, lactating women, women of childbearing age and spouse refused to take effective means of contraception contraception; no legal capacity, continue to influence medical or ethical reasons for who

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PLAGH Beijing China 100853
    2 PLA307 Beijing China

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Study Chair: j x li, doctor, Haidian District Fuxing Road, Beijing No. 28 Department of radiotherapy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    zhifei zhao, resident physician, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT02047487
    Other Study ID Numbers:
    • S2013-110-02
    First Posted:
    Jan 28, 2014
    Last Update Posted:
    Jan 28, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Jan 28, 2014