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Reduced Target Delineation Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03389295
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Xiayun He, MD, Fudan University

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE January 3, 2018
Last Update Posted Date January 3, 2018
Actual Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2017)
Progression-free survival [ Time Frame: up to 3 years ]
The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 3 years.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2017)
  • Overall survival [ Time Frame: up to 3 years ]
    The time from date of treatment until date of death due to any cause, assessed up to 3 years.
  • Locoregional recurrence-free survival [ Time Frame: up to 3 years ]
    The time from date of treatment until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.
  • Distant metastasis-free survival [ Time Frame: up to 3 years ]
    The time from date of treatment until date of first documented distant metastasis, assessed up to 3 years.
  • Number of participants with hematologic toxicity events [ Time Frame: 1, 2 , 3 weeks post-dose ]
    Number of participants with hematologic toxicity events occurred during two cycles of induction and adjuvant chemotherapy according to CTCAE v4.
  • Number of participants with acute toxicities [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the radiotherapy
  • Number of participants with late toxicities [ Time Frame: up to 3 years ]
    Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash or neurological toxicities) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0
  • Changes of tumor volume [ Time Frame: 2 weeks after completion of induction chemotherapy ]
    Changes of tumor volume before and after induction chemotherapy
  • Relationship between treatment failure and dose received by target [ Time Frame: up to 3 years ]
    Relationship between treatment failure and dose received by target
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduced Target Delineation Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title  ICMJE Sequential Chemoradiotherapy With Reduced Target Delineation During Radiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Brief Summary To determine the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation radiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma
Detailed Description Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. Besides, a common problem in locally advanced NPC is the narrow gap between the tumor and critical normal structures, which makes dose optimization difficult. Considering that significant tumor shrinkage may occur during induction chemotherapy, and incidences of distant metastases may be reduced by adjuvant chemotherapy, this study was designed to explore the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation radiotherapy for patients with locoregionally advanced NPC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) Radiotherapy:Reduced Target Delineation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE Radiation: Reduced Target Delineation
The target volumes were delineated according to the treatment protocol defined as follows: the GTV of the primary tumor (GTV-P) included retropharyngeal lymph nodes, considering the common phenomena of integration, and the rest involved lymph nodes that were defined as GTV-N. For the GTV-P, involved retropharyngeal lymph nodes and intracavity lesions were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) were delineated according to the pre-IC volume of the primary lesion as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for GTV-N delineation.
Other Name: Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion)
Study Arms  ICMJE Experimental: Reduced Target Delineation Chemoradiotherapy
All patients were assigned to receive induction chemotherapy (IC) followed by IMRT with adjuvant chemotherapy (AC). IMRT was administered 2 weeks after IC, and AC was administered 1 month after IMRT. IC or AC (TPF regimen) comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) administered once every 3 weeks for two cycles. During radiotherapy, involved retropharyngeal lymph nodes and intracavity lesions of the primary tumor were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) of the primary tumor were delineated according to the pre-IC volume of the primary tumor as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for delineation.
Intervention: Radiation: Reduced Target Delineation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2017)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
  2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2010)
  3. ECOG performance status of 0-1
  4. Life expectancy of more than 6 months
  5. Signed written informed consent
  6. Adequate organ function including the following:

Absolute neutrophil count (ANC) >= 1.5 * 109/l Platelets count >= 100 * 109/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine <= 1 times ULN

Exclusion Criteria:

  1. Evidence of distant metastasis
  2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiayun He, MD +86-18017312167 hexiayun1962@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03389295
Other Study ID Numbers  ICMJE TPF-Shanghai
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiayun He, MD, Fudan University
Study Sponsor  ICMJE Xiayun He, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP