Comparing Gemcitabine/Cisplatin before or after radiation for Nasopharyngeal Carcinoma
Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma: A Randomized Phase III Trial
This study is testing whether giving chemotherapy before or after radiation helps people with advanced nasopharyngeal cancer live longer and have fewer treatment problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Kuwait Cancer Control Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 1 site (Kuwait) |
| Trial ID | NCT04898374 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of gemcitabine and cisplatin as either induction chemotherapy before concurrent chemoradiation or as adjuvant chemotherapy after treatment in patients with locally advanced non-metastatic nasopharyngeal carcinoma. The study aims to determine the optimal timing of chemotherapy to improve survival rates and reduce treatment failures. Participants will be closely monitored for their response to treatment and any side effects experienced. The trial is designed to provide insights into the best practices for managing this specific type of cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with newly diagnosed, histologically confirmed stage III nasopharyngeal carcinoma.
Not a fit: Patients over the age of 70 or those with certain health conditions that disqualify them from receiving chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with nasopharyngeal carcinoma.
How similar studies have performed: Previous studies have shown mixed results regarding the timing of chemotherapy in conjunction with radiation, making this approach both relevant and necessary to explore further.
Eligibility criteria
Show full inclusion / exclusion 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: 1. Age ≥70 or \<18 2. The patient has evidence of distant metastatic disease. 3. The patient has received prior systemic chemotherapy within the last three years. 4. The patient has undergone previous surgery for the tumor, other than biopsy. 5. The patient has received prior radiation therapy to the head or neck 6. The patient is pregnant or breast feeding. 7. 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. 8. Has known history of Human Immunodeficiency Virus (HIV) 9. Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, 10. Has a history of severe hypersensitivity reaction to Cisplatin, Gemcitabine or radiotherapy or their analogs 11. Unstable cardiac disease requiring treatment.
Where this trial is running
Kuwait
- Kuwait Cancer Control Center — Kuwait, Kuwait (Recruiting)
Study contacts
- Principal investigator: Shereen Issa, MD — Kccc
- Study coordinator: Mustafa Alsherify, MD
- Email: Mustafashawki@yahoo.com
- Phone: 55466285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.