Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma
A Multicenter, Prospective, Randomized, Phase II Trial Evaluating Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2018
CompletedFirst Submitted
Initial submission to the registry
July 14, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2022
CompletedAugust 3, 2023
August 1, 2023
1.9 years
July 14, 2018
August 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death
2 years
Secondary Outcomes (3)
Overall survival
2 years
Locoregional relapse-free survival
2 years
Distant metastasis-free survival
2 years
Study Arms (2)
Hypofractionated dose IMRT
EXPERIMENTALPatients receive hypofractionated with a low total dose radiation with induced chemotherapy and adjuvant chemotherapy.
Standard-dose IMRT
EXPERIMENTALPatients receive standard-dose radiation therapy with induced chemotherapy and adjuvant chemotherapy..
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- No pregnant female
- Age between 18-70
- Normal complete blood count level (hemoglobin \>10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL)
- Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase \< 2.5 times higher than upper limit)
- Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min)
- Karnofsky performance status (KPS) score of at least 70
- Without radiotherapy or chemotherapy
- Patients must give signed informed consent
You may not qualify if:
- Other or mixed pathological type
- age \> 70 years or \<18 years
- Prior chemotherapy, radiation, surgical resection or target therapy of the primary tumor;
- 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;
- Refused to sign informed consent form
- Concurrent pregnancy or lactation
- History of a second malignancy other than nasopharyngeal carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wei Jianglead
- Wuzhou Red Cross Hospitalcollaborator
- Guangxi Naxishan Hospitalcollaborator
- Nanning Monority Hospitalcollaborator
- Lingshan people's Hospitalcollaborator
Study Sites (3)
Guangxi Naxishan Hospital
Guilin, China
Linshan people's hospital
Linshan, China
Wuzhou Red Cross Hospital
Wuzhou, China
Related Publications (1)
Liu J, Zhang B, Su Y, Qin G, Kong X, Mo Y, Zhang R, Jiang W. Hypofractionated radiotherapy compared with conventionally fractionated radiotherapy to treat initial distant metastases in nasopharyngeal carcinoma: A multicenter, prospective, randomized, phase II trial. Radiother Oncol. 2023 Oct;187:109815. doi: 10.1016/j.radonc.2023.109815. Epub 2023 Jul 20.
PMID: 37480994DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wei Jiang, Ph.D.
Guilin Medical University, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Wei Jiang, MD, PhD
Study Record Dates
First Submitted
July 14, 2018
First Posted
July 26, 2018
Study Start
July 13, 2018
Primary Completion
June 10, 2020
Study Completion
April 10, 2022
Last Updated
August 3, 2023
Record last verified: 2023-08