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

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ClinicalTrials.gov Identifier: NCT02801487
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Jiade J. Lu, 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) 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 subacute 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: CIRT with concurrent chemo arm Phase 1 Phase 2

Detailed 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 subacute 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma
Study Start Date : September 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CIRT with concurrent chemo arm
Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m^2, weekly).
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. Ninety-five percent (95%) of the isodose line should cover the GTV+3~5mm. Cisplatin (40mg/m^2) monotherapy will be given weekly along with radiotherapy.




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Time interval from the start to 4 months after the completion of concurrent chemoradiotherapy ]

Secondary Outcome Measures :
  1. Overall survival of all patients [ Time Frame: From the diagnosis of local recurrence of NPC, a median of 2 years ]
  2. Progression-free survival of all patients [ Time Frame: Time Frame: From the completion of CIRT, a median of 2 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801487


Contacts
Contact: Lin Kong, MD lin.kong@sphic.org.cn
Contact: Jiyi Hu, MD jiyi.hu@sphic.org.cn

Locations
China, Shanghai
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, Shanghai, China, 201315
Contact: Lin Kong, MD       lin.kong@sphic.org.cn   
Contact: Jiyi Hu, MD       jiyi.hu@sphic.org.cn   
Principal Investigator: Jiade J Lu, MD         
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Principal Investigator: Jiade J Lu, MD Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Responsible Party: Jiade J. Lu, MD, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02801487     History of Changes
Obsolete Identifiers: NCT02795169
Other Study ID Numbers: SPHIC-TR-HNCNS-2015-02
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

Keywords provided by Jiade J. Lu, Shanghai Proton and Heavy Ion Center:
Carbon Ion Therapy
Concurrent Chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases