Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

NCT ID: NCT04528394

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2022-06-30

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Photon

Intervention Type: RADIATION

Photon combined with Carbon ion in Arm 1

Carbon ion

Intervention Type: RADIATION

Same dose and fractionation will be used in both arms.

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.

Group Type: EXPERIMENTAL

Proton

Intervention Type: RADIATION

Proton combined with Carbon ion in Arm 2

Carbon ion

Intervention Type: RADIATION

Same dose and fractionation will be used in both arms.

Interventions

Photon

Photon combined with Carbon ion in Arm 1

Intervention Type: RADIATION

Proton

Proton combined with Carbon ion in Arm 2

Intervention Type: RADIATION

Carbon ion

Same dose and fractionation will be used in both arms.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Jiade J. Lu

Executive Vice-President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiade Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Locations

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Kong, MD

Role: CONTACT

lin.kong@sphic.org.cn

133XXX

Jiyi Hu, MD

Role: CONTACT

jiyi.hu@sphic.org.cn

1333XXX

Facility Contacts

Lin Kong, MD

Role: primary

lin.kong@sphic.org.cn

Jiyi Hu, MD

Role: backup

jiyi.hu@sphic.org.cn

Other Identifiers

SPHIC-TR-HNCNS-2019-32

Identifier Type: -

Identifier Source: org_study_id