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Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03598218
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
Wuzhou Red Cross Hospital
Guangxi Naxishan Hospital
Nanning Monority Hospital
Linshan pepole Hospital
Information provided by (Responsible Party):
Wei Jiang, Guilin Medical University, China

Brief Summary:
Radiotherapy is an important treatment for initial distant metastases nasopharyngeal carcinoma. Total dose and fraction size are important prognostic factors for survival, although to our knowledge the optimal model has not been well determined to date. The purpose of this clinical trial is to investigate the optimal radiation dose to investigate the feasibility of decreasing the total dose and increasing the fraction size with the objective of achieving a better balance between local control and severe late complications. for initial distant metastases nasopharyngeal carcinoma with definitive radiotherapy.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Hypofraction radiation Radiation: Standard dose IMRT Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if hypofractionated with a smaller total dose radiation is not inferior to standard-dose radiation in progression-free survival for initial distant metastases nasopharyngeal carcinoma .

SECONDARY OBJECTIVES:

I. To evaluate if hypofractionated with a low total dose radiation is not inferior to standard-dose radiation in overall survival and locoregional failure-free survival for initial distant metastases nasopharyngeal carcinoma II. To evaluate if hypofractionated with a low total dose radiation with chemotherapy decrease treatment-related toxicities

OUTLINE:

Patients are randomized to one of the two treatment arms

ARM 1: Patients receive hypofractionated with a low total dose radiation with induced chemotherapy and adjuvant chemotherapy.Hypofractionated dose IMRT: GTVnx 60Gy, GTVnd 60Gy, PTV1 50Gy and PTV2 45Gy in 25 fractions, 5 days/week.

Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.

ARM 2: Patients receive standard-dose radiation with concurrent chemotherapy. Standard-dose IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.

Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.

After completion of study therapy, patients are followed up every 3-4 months for 2 years, then every 6 months for 3 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Phase II Trial Evaluating Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : July 13, 2020
Estimated Study Completion Date : July 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypofractionated dose IMRT
Patients receive hypofractionated with a low total dose radiation with induced chemotherapy and adjuvant chemotherapy.
Radiation: Hypofraction radiation

Hypofractionated dose IMRT: GTVnx 60Gy, GTVnd 60Gy, PTV1 50Gy and PTV2 45Gy in 25 fractions, 5 days/week.

Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.


Experimental: Standard-dose IMRT
Patients receive standard-dose radiation therapy with induced chemotherapy and adjuvant chemotherapy..
Radiation: Standard dose IMRT

Standard dose IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 54.9Gy and PTV2 54Gy in 33 fractions, 5 days/week.

Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles.





Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    The time from the first day of therapy to death or last follow-up.

  2. Locoregional relapse-free survival [ Time Frame: 2 years ]
    The time from the first day of treatment to the time of first locoregional relapse

  3. Distant metastasis-free survival [ Time Frame: 2 years ]
    The time from the first day of treatment to the time of first distant metastasis



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type) Tumor staged as any T or any N with M (according to the 8th AJCC edition).
  2. No pregnant female
  3. Age between 18-70
  4. Normal complete blood count level (hemoglobin >10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL)
  5. Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase < 2.5 times higher than upper limit)
  6. Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min)
  7. Karnofsky performance status (KPS) score of at least 70
  8. Without radiotherapy or chemotherapy
  9. Patients must give signed informed consent

Exclusion Criteria:

  1. Other or mixed pathological type
  2. age > 70 years or <18 years
  3. Prior chemotherapy, radiation, surgical resection or target therapy of the primary tumor;
  4. Significant medical or psychiatric illnesses that in the physician's judgment (uncontrolled coronary heart disease, cardiomyopathy and/or heart failure requiring hospitalization. Uncontrolled hypertension or history of myocardial infarction within one year. Uncontrolled diabetes mellitus. Acute bacterial or fungal infection requiring intravenous antibiotics;
  5. Refused to sign informed consent form
  6. Concurrent pregnancy or lactation
  7. History of a second malignancy other than nasopharyngeal carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598218


Contacts
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Contact: Rui Cai, M.D. +86-773-2882906 33503706@qq.com

Locations
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China
Guangxi Naxishan Hospital Recruiting
Guilin, China
Contact: Yu-fei Pan, M.D.         
Linshan people's hospital Recruiting
Linshan, China
Contact: Yi-xin Su         
Wuzhou Red Cross Hospital Recruiting
Wuzhou, China
Contact: Bin Zhang, M.D.         
Sponsors and Collaborators
Wei Jiang
Wuzhou Red Cross Hospital
Guangxi Naxishan Hospital
Nanning Monority Hospital
Linshan pepole Hospital
Investigators
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Study Director: Wei Jiang, Ph.D. Guilin Medical University, China

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Responsible Party: Wei Jiang, Wei Jiang, MD, PhD, Guilin Medical University, China
ClinicalTrials.gov Identifier: NCT03598218     History of Changes
Other Study ID Numbers: GLMU-03
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wei Jiang, Guilin Medical University, China:
Hypofractionated Radiation
initial distant metastases
nasopharyngeal carcinoma

Additional relevant MeSH terms:
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Neoplasm Metastasis
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Neoplastic Processes
Pathologic Processes
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases