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Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC

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: NCT03326947
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine

Brief Summary:
To investigate the predictive value of stathmin expression as a predictive biomarker in OSCC patients, who treated with TPF (docetaxel, cisplatin and 5-fluorouracil ) induction chemotherapy followed by radical surgery and radiotherapy/chemoradiotherapy.

Condition or disease Intervention/treatment Phase
Neoplasm Neck Drug: docetaxel, cisplatin and 5-fluorouracil Phase 2

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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: A Randomized Phase II Trial of Low Stathmin Expression as a Predictive Biomarker for OSCC Patients Receiving TPF Induction Chemotherapy Followed by Radical Surgery and Radiotherapy/Chemoradiotherapy
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TPF group

The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed with surgery and radiotherapy/chemoradiotherapy.

docetaxel:75mg/m2 cisplatin:75 mg/m2 5-Fu:750 mg/m2/day

Drug: docetaxel, cisplatin and 5-fluorouracil

Drug: TPF induction chemotherapy TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m^2), cisplatin(75 mg/m^2), 5-Fu(750 mg/m^2/day) for 5 days; 16 days later, the 2nd cycle. 2 weeks later, surgery.

Surgery: radical resection and full neck dissection with reconstruction. Radiotherapy: 4-6 weeks after surgery, 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy, for high risk factors, concurrent chemotherapy with cisplatin of 80mg/m2.

Other Names:

TPF protocol group Procedure/Surgery: surgery In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.

Radiation: radiotherapy


No Intervention: Control group
The patients in the control group received the radical surgery and radiotherapy/chemoradiotherapy.



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 12 weeks. ]
    Overall survival was calculated from the date of randomization to death from any cause


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 12 weeks. ]
    Disease free survival was calculated from the date of randomization to recurrence, locoregional recurrence, or death from any cause



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pathological diagnosis of squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).

Age: 18 to 75 years old. Sex: both males and females. Karnofsky performance status (KPS) >70. Low grade of Stathmin 1 expression by immunohistochemistry. Clinical stage III/IVA. White blood cell >3,000/mm3, hemoglobin>8g/L, platelet count>80,000/mm3. Hepatic function: ALAT(alanine aminotransferase )/ASAT(aspartate transaminase ) <2.5 times the upper limit of normal (ULN), bilirubin <1.5 times ULN.

Serum creatinine <1.5 times ULN. Written informed consent

Exclusion Criteria:

Distant metastatic disease and other cancers. Previous surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).

Previous radiotherapy or chemotherapy. Other previous malignancies within 5 years. Sever systematic diseases such as severe pulmonary or cardiac diseases. Legal incapacity or limited legal capacity. Creatinine clearance <30ml/min. Pregnancy (confirmed by serum or urine β-HCG) or lactation period


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): NCT03326947


Locations
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China, Shanghai
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200011
Contact: Lai-ping Zhong, MD, PhD    +86-21-23271699 ext 5160    zhonglaiping@163.com   
Principal Investigator: Lai-ping Zhong, MD, PhD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Responsible Party: Lai-ping Zhong, Prof., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03326947    
Other Study ID Numbers: Stathmin for TPF in OSCC
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Two years after the results published.
Access Criteria: Access should be agreed by the PI.

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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 Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:
TPF induction chemotherapy, randomized, trial,OSCC
Additional relevant MeSH terms:
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Docetaxel
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs