Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase I/II Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02795169
• Other study ID #: SPHIC-TR-HNCNS-2015-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 6, 2016
• Last updated: June 6, 2016
• Start date: September 2015
• Est. completion date: March 2021

Study information

• Verified date: June 2016
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Lin Kong, MD
• Email: lin.kong[@]sphic.org.cn
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• 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) along with concurrent chemotherapy 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 along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. 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) along with concurrent chemotherapy in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD in the setting of concurrent chemoradiotherapy. Participants will be treated with CIRT with escalating dose starting from 52.5GyE (2.5GyE/daily fraction) to potentially 62.5GyE (2.5GyE/daily fraction) along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. Time-to-event continual reassessment method (TITE-CRM) is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. Once the MTD in the setting of concurrent chemoradiotherapy 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: Recruiting
• Enrollment: 62
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed NPC

• 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 CIS of the cervix, BCC and SCC of the skin within the past 5 years

• Refusal of the patient to participate into the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• CIRT with concurrent chemo arm
Five dose levels (52.5GyE, 55GyE, 57.5GyE, 60GyE, 62.5GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 62.5 GyE are safely delivered, the recommended dose (or 62.5 GyE) will be the prescribed dose in the Phase II part of the study. Ninty-five percent (95%) of the isodose line should cover the GTV+3~5mm. Cisplatin (40mg/m^2) monotherapy will be given weely along with radiotherapy.

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 to 4 months after the completion of concurrent chemoradiotherapy	Yes
Secondary	Overall survival of all patients		From the diagnosis of local recurrence of NPC, a median of 2 years	Yes
Secondary	Progression-free survival of all patients		Time Frame: From the completion of CIRT, a median of 2 years	Yes