TCTR20180831004
Not yet recruiting
Phase 2
Phase II study: Response adapted radiation therapy after induction chemotherapy in stage II-IVA nasopharyngeal carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Due to the reports of radiation dose reduction in clinical response to induction chemotherapy of NPC patients are scarce. Therefore,
- Sponsor
- one
- Enrollment
- 138
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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