1、Enough CasesPhase 2/3NCT01689558
Recombine Endostatin With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Advanced Nasopharynx Cancer
A Phase 2/3 study testing Recombine Endostatin in people with 1、Enough Cases and 2、Elekta Precise 1343 Digital Control Electron Linear Accelerator, run by Jin Feng at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- 1、Enough Cases, 2、Elekta Precise 1343 Digital Control Electron Linear Accelerator, Can Undertake Nasopharyngeal Carcinoma Specimens in the Materia，
- What is being tested?
- Recombine Endostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jan 2017
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Guizhou province
Guiyang, Guizhou, 550002
Feng Jin, Professor, +86 13985124806, jinf8865@gmail.com
Feng Jin, Professor
About this study
Official title: Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
- 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.
Read the detailed description
- 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)
- 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)
- Conditions
- 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,
- Being tested
- Recombine Endostatin
- Keywords
- nasopharynx cancer,Image department of nose pharynx ministry
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombine EndostatinDrug
Also called recombinant human vascular endothelial inhibin
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
| Study group | Role | What they receive |
|---|---|---|
| Recombine Endostatin | Experimental | 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 Receives: Drug: Recombine Endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
main objective
- 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.
Measured: at the end of the Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2015 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1、Enough CasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Feng, Cancer Hospital of Guizhou Province
- Investigators
- Jin Feng, Professor, Principal investigator, Cancer Hospital of Guizhou Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689558
- Sponsor's protocol ID
- 20111220
- Status last verified
- Mar 2013
- First submitted
- 12 Aug 2012
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01689558
- Acronym / sponsor ID
- 20111220
- Conditions
- 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,
- Keywords
- nasopharynx cancer,Image department of nose pharynx ministry
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jin FengUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 21 Sep 2012 (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.
- 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.
Detailed description
- 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)
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombine Endostatin | Experimental | Drug: Recombine EndostatinInduction 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombine EndostatinAlso: recombinant human vascular endothelial inhibinRecombine 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 | Drug | Recombine Endostatin |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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.
Jin Feng, Professor principal investigator
Cancer Hospital of Guizhou Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Recombine Endostatin in people with 1、Enough Cases and 2、Elekta Precise 1343 Digital Control Electron Linear Accelerator, run by Jin Feng at 1 site 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 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Feng Jin, Professor (+86 13985124806, jinf8865@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
main objective (time frame: at the end of the Radiation). 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 12 Mar 2013.