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A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285543
First Posted: November 7, 2014
Last Update Posted: August 21, 2017
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.
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine
  Purpose
To confirm the subgroup result from TPF (docetaxel, cisplatin and 5-fluorouracil ) trial (NCT01542931) that cN2 OSCC patients could benefit from TPF induction chemotherapy compared to the standard treatment.

Condition Intervention Phase
Mouth Neoplasms Carcinoma, Squamous Cell Drug: TPF induction chemotherapy Procedure: surgery Radiation: radiotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of TPF Induction Chemotherapy in cN2 Patients With Oral Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:

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

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

Estimated Enrollment: 101
Actual Study Start Date: December 2016
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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

Other Name: TPF protocol group
Procedure: 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
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(gray)/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
Control group
The patients in the control group received the radical surgery and radiotherapy/chemoradiotherapy.
Procedure: 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
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(gray)/day, 5 days/week for 6 weeks, and totally 54-60 Gy.

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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).
  • 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
  Contacts and Locations
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): NCT02285543


Locations
China, Shanghai
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

Responsible Party: Lai-ping Zhong, Professor,PHD,DDS,MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02285543     History of Changes
Other Study ID Numbers: TOPIC
First Submitted: October 22, 2014
First Posted: November 7, 2014
Last Update Posted: August 21, 2017
Last Verified: November 2015

Keywords provided by Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:
TPF induction chemotherapy, randomized, trial,OSCC

Additional relevant MeSH terms:
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