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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by Jiade J. Lu, Shanghai Proton and Heavy Ion Center
Sponsor:
Information provided by (Responsible Party):
Jiade J. Lu, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT02795195
First received: June 6, 2016
Last updated: NA
Last verified: June 2016
History: No changes posted
  Purpose
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 regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue 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.

Condition Intervention Phase
Nasopharyngeal Carcinoma Radiation: CIRT arm (3GyE per fraction) Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Jiade J. Lu, Shanghai Proton and Heavy Ion Center:

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

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

Estimated Enrollment: 58
Study Start Date: January 2016
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CIRT arm (3GyE per fraction)
treated with carcon ion radiotherapy with a fraction size of 3GyE.
Radiation: CIRT arm (3GyE per fraction)
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., MTD, 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. Ninty-five percent (95%) of the isodose line should cover the GTV+3~5mm.

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 subactue 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.
  Eligibility

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

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02795195

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, 201321
Contact: Lin Kong, MD       lin.kong@sphic.org.cn   
Contact: Jiyi Hu, MD       jiyi.hu@sphic.org.cn   
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Principal Investigator: Jiade J Lu, MD Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
  More Information

Responsible Party: Jiade J. Lu, Professor, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02795195     History of Changes
Other Study ID Numbers: SPHIC-TR-HNCNS-2015-03
Study First Received: June 6, 2016
Last Updated: June 6, 2016

Keywords provided by Jiade J. Lu, Shanghai Proton and Heavy Ion Center:
re-irradiation
carbon ion therapy

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

ClinicalTrials.gov processed this record on July 21, 2017