Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Proton; Radiation: Photon; Radiation: Carbon ion

• Registration Number: NCT04528394
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

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.

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 Timeline

• Study Start: 2019-04-29
• Status Verified: 2020-08
• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Last Update Submitted: 2020-08-24
• Study First Posted: 2020-08-27
• Last Update Posted: 2020-08-27
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton combined with Carbon ion	Proton	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.
Photon combined with Carbon ion	Photon	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.
Photon combined with Carbon ion	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.
Proton combined with Carbon ion	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03	Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy	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.

Secondary Outcome Measures

Name	Time	Method
Local control	From randomization to local failure, a median of 3 years.
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.
Treatment-related adverse events as assessed by NCI CTCAE v4.03	Time interval from start to 3 months after completion of radiotherapy.	Acute and late toxicities induced by radiation therapy other than xerostomia.
Distant control	From randomization to distant failure, a median of 3 year.
Regional control	From randomization to regional failure, a median of 3 years.

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion Center; 🇨🇳 Shanghai, Shanghai, China