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Clinical Trials/TCTR20180831004
TCTR20180831004
Not yet recruiting
Phase 2

Phase II study: Response adapted radiation therapy after induction chemotherapy in stage II-IVA nasopharyngeal carcinoma

one0 sites138 target enrollmentAugust 31, 2018

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&#44
Sponsor
one
Enrollment
138
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 31, 2018
End Date
September 15, 2020
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
one

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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