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

NCT02795195 | Completed Phase 1 DMC

• 1 other identifier: SPHIC-TR-HNCNS-2015-03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

re-irradiation; carbon ion therapy

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (phase 1)

  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%.

  Within 4 months after the completion of treatment

• Phase 2: Overall survival (OS)

  Overall survival (OS) was defined as the time frame from enrollment to the date of death from any cause.

  2 years

Secondary Outcomes (1)

• Phase 2: Progression-free survival

  2 years

Study Arms (1)

CIRT Arm (3GyE per fraction)

EXPERIMENTAL

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

Radiation: Carbon ion radiotherapy (CIRT)

Interventions

Carbon ion radiotherapy (CIRT) 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.

CIRT Arm (3GyE per fraction)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201321, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Jiade J Lu, MD

  Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 10, 2016
• Study Start: January 1, 2016
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)