Phase II study: Response adapted radiation therapy after induction chemotherapy in stage II-IVA nasopharyngeal carcinoma
- Conditions
- Due to the reports of radiation dose reduction in clinical response to induction chemotherapy of NPC patients are scarce. Therefore,We propose a phase II study to evaluate efficacy and feasibility ofnasopharyngeal carcinoma ,induction chemotherapy ,EBV DNA viral load
- Registration Number
- TCTR20180831004
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 138
1. Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO I-III, Stage II-IVA (AJCC staging 2017)
2. Initial detectable pretreatment EBV> 1,500 or undetectable pretreatment EBV
3. No previous head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
4. ≥ 18 years of age
5. Karnofsky performance scale ≥ 70
6. Acceptable laboratory investigation: WBC ≥ 3,000/μl, platelets ≥ 100,000/μl; serum creatinine ≤ 1.6 mg/dl or creatinine clearance ≥ 60 ml/min using the following formula:
Estimated Creatinine Clearance = [140 †age (y)] x Body weight (kg) x 0.85 if female
72 Serum creatinine (mg/dl)
7. Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment
8. Signed study-specific informed consent form prior to study entry
1. Stage I and IVB
2. Previous irradiation for head and neck tumor ≤ 6 months prior to study entry
3.Prior chemotherapy ≤ 6 months to study entry
4.Patients on any other experimental therapeutic cancer treatment
5.Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years
6.Active untreated infection
7.Major medical or psychiatric illness, which would interfere with either completion of therapy or follow-up or with full and complete understanding of the risks and potential complications of the therapy
8.Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Locoregional failure free survival (LRFFS) 2 years MRI/CT scan a and physical examination
- Secondary Outcome Measures
Name Time Method PFS, DMFS and OS 2yr MRI/CT scan a and physical examination,acute and late toxicities 2yr Common Terminology Criteria for Adverse Events v4.03(CTCEA),EBV DNA response for prediction of PFS,OS and DMFS 2yr MRI/CT scan a and physical examination