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Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage

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: NCT02290145
Recruitment Status : Recruiting
First Posted : November 13, 2014
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC

Condition or disease Intervention/treatment Phase
Mouth Neoplasms Carcinoma, Squamous Cell Drug: TPF group Procedure: surgery group Radiation: Post-operative radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TPF group
TPF induction chemotherapy followed with surgery and post-operative radiotherapy docetaxel 75mg/m2 cisplatin 75 mg/m2 5-Fu 750 mg/m2/day
Drug: TPF group

The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy.

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

Other Name: TPF protocol group

Procedure: surgery group
The patients in the control group received the radical surgery and post-operative radiotherapy.

Radiation: Post-operative radiotherapy
Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.

surgery group
surgery with post-operative radiotherapy
Procedure: surgery group
The patients in the control group received the radical surgery and post-operative radiotherapy.

Radiation: Post-operative radiotherapy
Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.




Primary Outcome Measures :
  1. overall survival rate as a measure by the numbers of living patients [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. disease free survival as a measure by the number of patients without recurrence or death [ Time Frame: 2 year ]
  2. local recurrence free survival as a measure by the number of patients without recurrence [ Time Frame: 2 year ]
  3. distant metastasis free survival as a measure by the number of patients without metastasis [ Time Frame: 2 year ]


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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:

  • Age: 18 to 75 years old.
  • Sex: both males and females.
  • Karnofsky performance status (KPS) >60.
  • Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
  • Cyclin D1 high expression
  • Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC[International Union Against Cancer] 2002) with resectable lesions.
  • Adequate hematologic function: 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.
  • Renal function: serum creatinine <1.5 times ULN.
  • Written informed consent

Exclusion Criteria:

  • Evidence of distant metastatic disease and other cancers.
  • Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
  • Previous radiotherapy or chemotherapy.
  • Other previous malignancies within 5 years.
  • Can not tolerate the treatment protocol with systematic diseases such as history of 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): NCT02290145


Contacts
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Contact: Lai-pimg Zhong, PHD +86 021-23271699 zhonglaiping@163.com
Contact: Ying Liu, MPhil +86 15021196610 alllyliuying@gmail.com

Locations
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China, Shanghai
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200011
Contact: Lai-ping Zhong, PhD, MD, DDS    +86-21-23271699 ext 5160    zhonglaiping@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Responsible Party: Lai-ping Zhong, Professor,PHD,DDS,MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02290145    
Other Study ID Numbers: CDSCAN
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Keywords provided by Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:
docetaxel, cisplatin, 5-FU, cyclinD1
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases