Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The central hypothesis is to test Low Dose Fraction Radiotherapy (LDFRT), as a potentiator of Docetaxel and Cisplatin efficacy in locally advanced nasopharyngeal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Faisal Specialist Hospital & Research Center
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

1. WHO II-III carcinoma of the nasopharynx, histologically proven.

2. Locally advanced stage III and IV (minimal intracranial extension only) with absence of distant metastases.

3. Age between 18 and 70 years.

4. ECOG performance status 0-2.

5. Hematological function parameters performed within 10 days before inclusion:

• Neutrophils ≥ 1000 * 109/l.

• Platelets: ≥ 100 * 109/l.

• Hemoglobin: ≥ 9 g/dl

6. Adequate hepatic function, defined as follows within 2 weeks prior to registration:

• Total bilirubin is normal

• AST (SGOT) and ALT (SGPT) <= 2.5 * upper limit of normal (ULN) of each center.

• Alkaline phosphatase <= 2.5 * ULN.

7. Renal function parameters performed within 10 days before inclusion: normal serum creatinine and creatinine clearance must be ≥ 55 ml/min.

8. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

1. Patients who present stage I, IIa, IIb and IVc.

2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible);

3. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is permitted;

4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.

5. Head and neck surgery of the primary tumor or lymph nodes prior to registration, with the exception of incisional or excisional biopsies.

6. Patients receiving other experimental therapeutic cancer treatment;

7. Blood pressure at baseline > 150/100 mmHg;

8. Peripheral neuropathy CTCAE, v. 4.0 h grade 2

9. Severe, active co-morbidity, defined as follows:

• Major medical or psychiatric illness, which in the investigators' opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy.

• Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months, or other cardiac compromise that in the judgment of the investigator will preclude the safe administration of a study drug.

• Acquired Immune Deficiency.

• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

• Prior allergic reaction to the study drug(s) involved in this.