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

NCT ID: NCT02795195

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-04-22

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CIRT Arm (3GyE per fraction)

Patients included in this arm were treated with carbon ion radiotherapy with a fraction size of 3GyE.

Group Type: EXPERIMENTAL

Carbon ion radiotherapy (CIRT)

Intervention Type: RADIATION

Five dose levels (51GyE, 54GyE, 57GyE, 60GyE, 63GyE) are planned within the Phase I part. And the started dose level will be 54GyE. Daily fraction of 3 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., maximal tolerated dose, is determined or if the treatments to 63 GyE are safely delivered, the recommended dose (or 63 GyE) will be the prescribed dose in the Phase II part of the study.

Interventions

Carbon ion radiotherapy (CIRT)

Five dose levels (51GyE, 54GyE, 57GyE, 60GyE, 63GyE) are planned within the Phase I part. And the started dose level will be 54GyE. Daily fraction of 3 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., maximal tolerated dose, is determined or if the treatments to 63 GyE are safely delivered, the recommended dose (or 63 GyE) will be the prescribed dose in the Phase II part of the study.

Intervention Type: RADIATION

Eligibility Criteria

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

• 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

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiade J Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Locations

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SPHIC-TR-HNCNS-2015-03

Identifier Type: -

Identifier Source: org_study_id