Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma

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.

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Radiation: Photon; Radiation: Carbon ion; Radiation: Proton

Detailed Description

The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton 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 (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent [GyE]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201315
      • Recruiting
      • Shanghai Proton and Heavy Ion Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Photon combined with Carbon ion; The 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.	Radiation: Photon; Photon combined with Carbon ion in Arm 1; Radiation: Carbon ion; Same dose and fractionation will be used in both arms.
EXPERIMENTAL: Proton combined with Carbon ion; The 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.	Radiation: Carbon ion; Same dose and fractionation will be used in both arms.; Radiation: Proton; Proton combined with Carbon ion in Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Treatment-related adverse events as assessed by NCI CTCAE v4.03	Acute and late toxicities induced by radiation therapy other than xerostomia.	Time interval from start to 3 months after completion of radiotherapy.

Collaborators and Investigators

• Sponsor: Shanghai Proton and Heavy Ion Center
• Investigators: Principal Investigator: Jiade Lu, MD, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2019
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (ACTUAL): August 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Survival; Toxicity; Disease control; Nasopharyngeal carcinoma; Intensity-modulated radiation therapy; Proton beam therapy; Carbon-ion radiotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: SPHIC-TR-HNCNS-2019-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.
• IPD Sharing Time Frame: Within 5 years after the publication of the study
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No