Head and Neck NeoplasmsNCT02047487
After Induction Chemotherapy of DP Plus DDP Concurrent Radiotherapy With and Without Bevacizumab Study
An observational study of Head and Neck Neoplasms, run by Chinese PLA General Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Neoplasms
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- May 2013to Aug 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with pathological diagnosis of head and neck squamous cell carcinoma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
PLAGH
Beijing, 100853
- Recruiting
PLA307
Beijing
About this study
Official title: Docetaxel (T), Cisplatin (P) After Induction Chemotherapy With and Without Cisplatin (P) Concurrent Radiotherapy (X) Plus Bevacizumab (B) Phase II Clinical Study
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.
- Conditions
- Head and Neck Neoplasms
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: three month after ratiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhifei zhao, Chinese PLA General Hospital
- Investigators
- j x li, doctor, Study chair, Haidian District Fuxing Road, Beijing No. 28 Department of radiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047487
- Sponsor's protocol ID
- S2013-110-02
- Status last verified
- Jan 2014
- First submitted
- 26 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel (T), Cisplatin (P) After Induction Chemotherapy With and Without Cisplatin (P) Concurrent Radiotherapy (X) Plus Bevacizumab (B) Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT02047487
- Acronym / sponsor ID
- S2013-110-02
- Conditions
- Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathological diagnosis of head and neck squamous cell carcinoma
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORR
Time frame: three month after ratiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
j x li, doctor study chair
Haidian District Fuxing Road, Beijing No. 28 Department of radiotherapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Chinese PLA General Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact z f zhao, master (13301253566, zhifei115@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: three month after ratiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.