Status:
RECRUITING
Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Kuwait Cancer Control Center
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The standard of care for locally advanced nasopharyngeal carcinoma is radical chemoradiation(CRT).Recent advances in radiation techniques and supportive measures resulted in improvemnent of locoregion...
Detailed Description
Background Nasopharyngeal carcinoma (NPC) is one of the cancers which shows significant geographic prevalence variation. Worldwide, there were 130,000 new cases in 2018.As a non-endemic region, only ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04898374
Start Date
May 1 2021
End Date
April 30 2026
Last Update
August 17 2022
Active Locations (1)
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1
Kuwait Cancer Control Center
Kuwait City, Kuwait, 11911