Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03668730
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE June 8, 2018
First Posted Date  ICMJE September 13, 2018
Last Update Posted Date November 20, 2018
Actual Study Start Date  ICMJE November 19, 2018
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
PFS(progression free survival) [ Time Frame: 2 years ]
Defined from date of registration to date of first documentation of progression and/or distant metastasis,or death due to any cause. The primary study population for this endpoint is patients who were confirmed post-induction CR /PR and EBV DNA=0 and subsequently received 60Gy radiation therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03668730 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Overall Survival(OS) [ Time Frame: 2 years ]
    Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.
  • Locoregional relapse-free survival(LRFS) [ Time Frame: 2 years ]
    Defined from date of registration to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
  • Distant metastasis-free survival(DMFS) [ Time Frame: 2 years ]
    Defined from date of registration to date of first documentation of distant metastases or until the date of the last follow-up visit.
  • Overall response rate [ Time Frame: 2 years ]
    Tumour response rate was classified according to RECIST, version 1.1
  • Incidence of acute toxicity [ Time Frame: 2 years ]
    Numbers of patients of treatment-related adverse events as assessed by CTCAE v4.0.
  • Incidence of late toxicity [ Time Frame: 2 years ]
    Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
  • Change of ADC( apparent diffusion coefficient ) value of DWI(Diffusion-Weighted MRI) of patients predictive of failure [ Time Frame: 2 years ]
    The ADC value of each patient of Diffusion-Weighted MRI at pretreatment and after induction chemotherapy was calculated were evaluated independently on a work station.
  • Change of QoL [ Time Frame: 1 years ]
    QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy.
  • Change of EORTC quality of life questionnaire(QLQ) Head and Neck score [ Time Frame: 1 years ]
    QoL scores were assessed by using EORTC quality of life questionnaire(QLQ) Head and Neck. The QLQ-H&N35 is composed of seven multi-item symptom scales (pain, swallowing, sensation, speech, eating from a social,perspective, social interactions, and sexuality) and 11 single-item symptom scales (teeth, opening mouth,dry mouth, sticky saliva, coughing, felt ill, pain medication use, nutritional supplementation, feeding tube requirement, weight loss, and weight gain). All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems.
  • Plasma EBV DNA copy number [ Time Frame: 2 years ]
    Plasma EBV DNA copy number with either reduced or standard dose radiotherapy was assessed by qRT-PCR at pretreatment. The predictive value of plasma EBV DNA copy number was assessed by survival analysis.
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-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma
Official Title  ICMJE A Phase II Trial of Induction Chemotherapy Followed by Cisplatin With Low Dose vs. Standard Dose IMRT in Stage III Nasopharyngeal Carcinoma Patients With Pretreatment EBV DNA<4000 Copy/ml
Brief Summary To study the 2-year PFS (progression-free survival) of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.
Detailed Description

To explore the 2 year PFS of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA<4000 copy/ml treated with induction chemotherapy followed by reduced-dose radiation and cisplatin. The enrolled patients will receive 2 cycles of TPF regimen induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be delivered by 60 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. If radiographic SD/PD or EBV DNA>0 after induction chemotherapy, the patients will receive a total of 70 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

The included patients will be treated with 2 cycles of TPF regimen induction chemotherapy and 60Gy IMRT combined with cisplatin concurrent chemotherapy. The TPF regimen is consist of paclitaxel liposome 135mg/m2 d1, cisplatin 25mg/m2d1-d3 and 5-Fu 3750mg/m2 civ120h, with a total of two cycles. Concurrent cisplatin chemotherapy is delivered with dose of 100mg/m2, a total of three cycles. The third cycle of cisplatin concurrent chemotherapy is allowed to be delivered within one week after IMRT finished.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Radiation: Intensity-modulated radiation therapy
    Patients undergo low-dose OR standard dose IMRT based on their radiographic response to induction chemotherapy
  • Drug: Paclitaxel liposome
    Patients receive Paclitaxel liposome by 135mg/m2 with a total of two cycles.
  • Drug: Cisplatin
    Patients receive Cisplatin by 25mg/m2 on day1-day3 with a total of two cycles as induction chemotherapy ; patients receive cisplatin by 100mg/m2 with a total of three cycles as concurrent chemotherapy.
  • Drug: 5-Fluorouracil
    Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.
Study Arms  ICMJE
  • Experimental: Reduced dose group
    After 2 cycles of induction chemotherapy with Paclitaxel Liposome, Cisplatin and 5-Fluorouracil, patients undergo low-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive cisplatin once per three week for 3 cycles.
    Interventions:
    • Radiation: Intensity-modulated radiation therapy
    • Drug: Paclitaxel liposome
    • Drug: Cisplatin
    • Drug: 5-Fluorouracil
  • Experimental: Standard dose group
    After 2 cycles of induction chemotherapy with Paclitaxel Liposome,Cisplatin and 5-Fluorouracil, patients undergo standard-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (33 fractions). Patients also receive cisplatin once per three week for 3 cycles.
    Interventions:
    • Radiation: Intensity-modulated radiation therapy
    • Drug: Paclitaxel liposome
    • Drug: Cisplatin
    • Drug: 5-Fluorouracil
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: September 11, 2018)
118
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pathological diagnosis of NPC(WHO II or III).
  2. Stage III(8thAJCC/UICC staging system) and pretreatment EBVDNA<4000opies/ml.
  3. Aged 18—70 years。
  4. ECOG = 0-1。
  5. HGB≥90 g/L,WBC≥4×109 /L,PLT≥100×109 /L.
  6. ALT,AST<2.5 fold of ULN;TBIL<2.0×ULN。
  7. CCR≥60ml/min or Cr<1.5×ULN。
  8. Signed informed consent

Exclusion Criteria:

  1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  2. Age <18 or >70years.
  3. Treatment with palliative intent.
  4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  5. Pregnancy or lactation.
  6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
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: Hai Qiang Mai, MD.PHD 020-87343380 maihq@sysucc.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03668730
Other Study ID Numbers  ICMJE B2018-020-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hai Qiang Mai, MD.PHD Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date November 2018

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