Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma

Phase 1

Completed

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT02795195
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

Brief Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) with the fraction size of 3 gray equivalent (GyE) in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the MTD in terms of acute and subacute toxicity observed within 4 months after the completion of CIRT. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.

Detailed Description

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) with the fraction size of 3 GyE in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose starting from 54GyE (3GyE/daily fraction) to potentially 63GyE (3GyE/daily fraction) to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 4 months after the completion of CIRT. The TITE-CRM method is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial. The Phase II part of the trial will be a single stage single arm study.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Primary Completion: 2021-04-22
• Study Completion: 2021-04-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy
• Recurrence diagnosed more than 12 months after the initial course of IMXT
• Age ≥ 18 and < 70 years of age
• Karnofsky Performance Score ≥70
• Willing to accept adequate contraception for women with childbearing potential
• Ability to understand character and individual consequences of the clinical trial
• Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria

• Presence of distant metastasis
• Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC
• Pregnant or lactating women
• Patients who have not yet recovered from acute toxicities of prior therapies
• A diagnosis of malignancy other than carcinoma in situ of the cervix, basal cell carcinoma and squamous cell carcinoma of the skin within the past 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (phase 1)	Within 4 months after the completion of treatment	The primary objective of phase 1 is to identify the maximum tolerated dose which is defined as the highest dose associated with a probability of dose limiting toxicity \<=25%.
Phase 2: Overall survival (OS)	2 years	Overall survival (OS) was defined as the time frame from enrollment to the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
Phase 2: Progression-free survival	2 years	Progression-free survival (PFS) was defined as the time frame from enrollment to the date of disease progression or death whichever came first.

Trial Locations

Locations (1)

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