A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients (NCT02285543) | Clinical Trial Compass
TerminatedPhase 2
A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients
Stopped: No new participants could be enrolled.
China10 participantsStarted 2016-12-01
Plain-language 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 treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
overall survival rate as a measure by the numbers of living patients overall Survival rate
Timeframe: 2 year
Trial details
NCT IDNCT02285543
SponsorShanghai Jiao Tong University School of Medicine