Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528394
• Other study ID #: SPHIC-TR-HNCNS-2019-32
• Status: Recruiting
• Phase: Phase 2
• Start date: April 29, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Lin Kong, MD
• Phone: 133XXX
• Email: lin.kong[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• Photon
Photon combined with Carbon ion in Arm 1
• Proton
Proton combined with Carbon ion in Arm 2
• Carbon ion
Same dose and fractionation will be used in both arms.

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival of all patients		From randomization to death, a median of 3 years.
Secondary	Progression-free survival of all patients		From randomization to death or disease progression, a median of 3 years.
Secondary	Local control		From randomization to local failure, a median of 3 years.
Secondary	Regional control		From randomization to regional failure, a median of 3 years.
Secondary	Distant control		From randomization to distant failure, a median of 3 year.
Secondary	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.