Status:
TERMINATED
A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Mouth Neoplasms
Carcinoma, Squamous Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 tre...
Detailed Description
Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02285543
Start Date
December 1 2016
End Date
July 30 2023
Last Update
November 22 2023
Active Locations (1)
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1
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011