Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma
A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
1 other identifier
interventional
136
1 country
1
Brief Summary
The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2019
CompletedFirst Submitted
Initial submission to the registry
August 24, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 27, 2020
August 1, 2020
2.2 years
August 24, 2020
August 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.
Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
Secondary Outcomes (6)
Overall survival of all patients
From randomization to death, a median of 3 years.
Progression-free survival of all patients
From randomization to death or disease progression, a median of 3 years.
Local control
From randomization to local failure, a median of 3 years.
Regional control
From randomization to regional failure, a median of 3 years.
Distant control
From randomization to distant failure, a median of 3 year.
- +1 more secondary outcomes
Study Arms (2)
Photon combined with Carbon ion
EXPERIMENTALThe participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
Proton combined with Carbon ion
EXPERIMENTALThe participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
Interventions
Same dose and fractionation will be used in both arms.
Eligibility Criteria
You may qualify if:
- Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
- Age ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group score: 0-1.
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \< 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase \< 1.5 upper limit of normal; 5) SCr \< 1.5mg/dl; creatinine clearance rate \> 60ml/min.
- Willing to accept adequate contraception for women with childbearing potential.
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.
You may not qualify if:
- Presence of distant metastasis.
- Received radiotherapy for head and neck before.
- Received surgery(except for biopsy) for primary lesion or cervical lymph node.
- Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
- Accompanied with severe major organ dysfunction.
- Presence of mental disease that may influence the understanding of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiade Lu, MD
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice-President
Study Record Dates
First Submitted
August 24, 2020
First Posted
August 27, 2020
Study Start
April 29, 2019
Primary Completion
June 30, 2021
Study Completion
June 30, 2022
Last Updated
August 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Within 5 years after the publication of the study
- Access Criteria
- Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Pooled analysis comparing IMRT and particle beam radiotherapy will be of particular interest. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.
Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.