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Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma
This study is currently recruiting participants.
Verified June 2016 by Jiade J. Lu, Shanghai Proton and Heavy Ion Center
Sponsor:
Shanghai Proton and Heavy Ion Center
Information provided by (Responsible Party):
Jiade J. Lu, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT02569788
First received: October 1, 2015
Last updated: June 6, 2016
Last verified: June 2016
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Purpose
The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) 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 | 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 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: | 62 |
| Study Start Date: | September 2015 |
| Estimated Study Completion Date: | March 2020 |
| Estimated Primary Completion Date: | March 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CIRT arm
treated with carcon ion radiotherapy.
|
Radiation: CIRT arm
Five dose levels (55GyE, 57.5GyE, 60GyE, 62.5GyE, 65GyE) 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 65 GyE are safely delivered, the recommended dose (or 65 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) 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 55GyE (2.5GyE/daily fraction) to potentially 65GyE (2.5GyE/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. 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 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:
- 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 ≥ 14 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: NCT02569788
Please refer to this study by its ClinicalTrials.gov identifier: NCT02569788
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: | NCT02569788 History of Changes |
| Other Study ID Numbers: |
SPHIC-TR-HNCNS-2015-01 |
| Study First Received: | October 1, 2015 |
| Last Updated: | June 6, 2016 |
Keywords provided by Jiade J. Lu, Shanghai Proton and Heavy Ion Center:
|
re-irradiation carbon ion radiotherapy |
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 |
ClinicalTrials.gov processed this record on July 11, 2017