After Induction Chemotherapy of DP Plus DDP Concurrent Radiotherapy With and Without Bevacizumab Study
Docetaxel (T), Cisplatin (P) After Induction Chemotherapy With and Without Cisplatin (P) Concurrent Radiotherapy (X) Plus Bevacizumab (B) Phase II Clinical Study
1 other identifier
observational
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 26, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJanuary 28, 2014
January 1, 2014
1.3 years
January 26, 2014
January 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
three month after ratiotherapy
Eligibility Criteria
Patients with pathological diagnosis of head and neck squamous cell carcinoma
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
PLAGH
Beijing, 100853, China
PLA307
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
j x li, doctor
Haidian District Fuxing Road, Beijing No. 28 Department of radiotherapy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident physician
Study Record Dates
First Submitted
January 26, 2014
First Posted
January 28, 2014
Study Start
May 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2018
Last Updated
January 28, 2014
Record last verified: 2014-01