Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

Shanghai Proton and Heavy Ion Center

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: Carbon ion; Radiation: Photon; Radiation: Proton

Study type: Interventional

Funder types: Other

Identifiers

NCT04528394

SPHIC-TR-HNCNS-2019-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Photon combined with Carbon ion

Experimental group

Description:

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.

Treatment:

Radiation: Carbon ion

Radiation: Photon

Proton combined with Carbon ion

Experimental group

Description:

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.

Treatment:

Radiation: Carbon ion

Radiation: Proton