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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase I/II Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02795195
• Other study ID #: SPHIC-TR-HNCNS-2015-03
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Shanghai Proton and Heavy Ion Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 during and 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.

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 classic 3+3 method is used for the phase I dose escalating part of the trial and approximately 4-18 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 phase single arm study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

• Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy

• 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

• Refusal of the patient to participate into the study

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• Carbon ion radiotherapy (CIRT)
Four dose levels (54GyE, 57GyE, 60GyE, 63GyE) are planned within the Phase I part. 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. Ninety-five percent (95%) of the isodose line should cover the gross tumor volume plus 3~5mm.

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 adverse events as assessed by CTCAE v4.0		Time interval from the start of CIRT to 4 months after the completion of CIRT
Secondary	Overall survival of all patients		From the diagnosis of local recurrence of NPC, a median of 2 years
Secondary	Progression-free survival of all patients		From the completion of CIRT, a median of 2 years