Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Induction chemotherapy, neoadjuvant, adjuvant, non-metastatic, Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
Patients with newly histologically confirmed Nasopharyngeal carcinoma (according to World Health Organization (WHO) 2. The patient has stage III except T3N0 or IVA disease (according to 8th American Joint Committee on Cancer staging system) 3. WHO performance status 0-1 . 4. The patient must have achieved lawful age to provide informed consent according to local or national law .
5. Laboratory values performed within 14 days prior to concurrent chemotherapy should be as follows: i) Absolute neutrophil count (ANC) ≥ 1500/mm ii) Platelet count ≥ 100.000/mm iii) Hemoglobin ≥ 8g/dl iv) Urea and serum creatinine ≤ 1.5 mg/dl. (for cisplatin) v) Creatinine clearance ≥ 60 ml/min. (for cisplatin) vi) SGOT and SGPT ≤ 2 × upper limit of laboratory normal 6. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
Exclusion Criteria:
- Age ≥70 or <18
- The patient has evidence of distant metastatic disease.
- The patient has received prior systemic chemotherapy within the last three years.
- The patient has undergone previous surgery for the tumor, other than biopsy.
- The patient has received prior radiation therapy to the head or neck
- The patient is pregnant or breast feeding.
- The patient has a medical (e.g. renal impairment) or psychological condition that would not permit the patient to complete the trial or sign informed consent.
- Has known history of Human Immunodeficiency Virus (HIV)
- Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy,
- Has a history of severe hypersensitivity reaction to Cisplatin, Gemcitabine or radiotherapy or their analogs
- Unstable cardiac disease requiring treatment.
Sites / Locations
- Kuwait Cancer Control CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Induction Arm
Adjuvant Arm
patients will receive three cycles of IC Gemcitabin/Cisplatin followed by radical CRT
Patients will receive radical CRT followed by three cycles of AC Gemcitabin/Cisplatin