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Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03117257
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Feng Jing, Guiyang Medical University

Brief Summary:
This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Locally Advanced Head and Neck Squamous Cell Carcinoma Drug: Lobaplatin Drug: Cisplatin Phase 2

Detailed Description:
TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin, direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : August 19, 2016
Estimated Primary Completion Date : August 19, 2019
Estimated Study Completion Date : August 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: the treatment group
docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy
Drug: Lobaplatin
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
Other Name: Platinum

Active Comparator: the control group
TPF induction chemotherapy combined with cisplatin chemoradiotherapy
Drug: Cisplatin
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
Other Name: cis-DDP; cis-Diammineplatinum(II) dichloride;




Primary Outcome Measures :
  1. National Cancer Institute CTCAE v4.0 [ Time Frame: 1 year ]
    Acute toxicity of radiotherapy and chemotherapy

  2. evaluation of immediate efficacy [ Time Frame: 1 year ]
    Evaluation of efficacy by RESIST1.1 standard


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.

  2. progression-free survival [ Time Frame: 5 years ]
    Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntary participation and written informed consent
  2. Age 18-70 years old, gender is not limited
  3. histologically proved to be squamous cell carcinoma
  4. No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period.

    After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients

  5. Karnofsky score ≥70
  6. Survival is expected to be ≥ 6 months
  7. Women of childbearing age should be guaranteed contraception during the study period
  8. (WBC) ≥4 × 109 / L * (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L * (unit normal value)
  9. liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <upper limit of normal (ULN) 1.5 times; total bilirubin <1.5 × ULN
  10. renal function: serum creatinine <1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min
  11. no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history
  12. The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).

Exclusion Criteria:

  1. There is a distant shift
  2. primary lesions or lymph nodes were radiotherapy
  3. had received epidermal growth factor targeted therapy
  4. primary tumor had received chemotherapy or immunotherapy
  5. had other malignancies (except for cured basal cell carcinoma or cervical cancer)
  6. pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age
  7. have a serious history of allergies or specific physical
  8. Abuse of drugs or alcohol addicts
  9. Person who has personality or mental illness, no civil capacity or limited civil capacity

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): NCT03117257


Contacts
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Contact: Feng Jin, Bachelor 86-851-86512802 jinf8865@yeah.net
Contact: Weili Wu, master 86-13885124077 wwlmhy@163.com

Locations
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China, Guizhou
Cancer Hospital of Guizhou Medical University Recruiting
Guiyang, Guizhou, China, 550000
Contact: Feng Jin, Bachelor    0851-86512802    jinf8865@yahoo.com.cn   
Sub-Investigator: Weili Wu, master         
Sub-Investigator: Jinhua Long, master         
Sub-Investigator: Yuanyuan Li, master         
Sub-Investigator: Xiuyun Gong, Bachelor         
Sub-Investigator: Xiaoxiao Chen, Bachelor         
Sub-Investigator: Mang Zhang, Bachelor         
Sponsors and Collaborators
Guiyang Medical University
Investigators
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Study Chair: Feng Jin, Bachelor Guizhou Provincial Cancer Hospital

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Responsible Party: Feng Jing, Head and neck cancer director, chief researcher, clinical professor, Guiyang Medical University
ClinicalTrials.gov Identifier: NCT03117257    
Other Study ID Numbers: 20160819
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Feng Jing, Guiyang Medical University:
Lobaplatin
head and neck cancer
chronic-chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action