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P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02429037
Recruitment Status : Unknown
Verified March 2015 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was:  Not yet recruiting
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd

Study Description
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Brief Summary:
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

Condition or disease Intervention/treatment Phase
Advanced Head and Neck Cancer Drug: rAd-p53 Radiation: radiation Drug: Cisplatin Phase 2

Detailed Description:
To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: rAd-p53 plus radiation and chemotherapy
rAd-p53 tumor injection combined with radio- and chemo-therapy.
 Drug: rAd-p53
multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle.
Other Name: p53 gene therapy

Radiation: radiation
radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.

Drug: Cisplatin
Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15
Other Name: chemotherapy: cisplatin
Active Comparator: radiation and chemotherapy
radiation combined with chemotherapy
 Radiation: radiation
radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.

Drug: Cisplatin
Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15
Other Name: chemotherapy: cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival [ Time Frame: three years after starting treatment ]
    Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: from starting study treatment until 30 days after the last study treatment ]
    Adverse events

  2. overall survival [ Time Frame: three years after starting study treatment ]
    Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histopathologically diagnosed head and neck cancer;
  2. unresectable, locally advanced;
  3. 18 years or older;
  4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
  5. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.

Exclusion Criteria:

  1. Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
  2. have serious heart, lung function abnormalities or severe diabetes patients;
  3. active infection;
  4. severe atherosclerosis;
  5. AIDS patients;
  6. serious thrombotic or embolic events within 6 months;
  7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
  8. pregnant or lactating women;
  9. mental disorder or disease.
Contacts and Locations
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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): NCT02429037


Contacts
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Contact: Xia He, MD, PhD 86-13601458518 13601458515@qq.com
Contact: Jianfeng Wu, MD, PhD 86-13923853040 595864485@qq.com

Locations
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China, Jiangsu
Jiangsu cancer hospital
Nanjing, Jiangsu, China, 210000
Contact: Xia He, MD, PhD    86-13601458518    13601458515@qq.com   
Contact: Jianfeng Wu, MD, PhD    86-13923753040    595864485@qq.com   
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd
More Information
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Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT02429037    
Other Study ID Numbers: rAd-p53-J1002
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: March 2015
Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
p53
gene therapy
head and neck cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Antineoplastic Agents