- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02801487
Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma
February 12, 2020 updated by: Jiade J. Lu, Shanghai Proton and Heavy Ion Center
Phase I/II Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
6
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 201315
- Shanghai Proton and Heavy Ion Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: CIRT with concurrent chemo arm
Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m^2, weekly).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Time interval from the start to 4 months after the completion of concurrent chemoradiotherapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival of all patients
Time Frame: From the diagnosis of local recurrence of NPC, a median of 2 years
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From the diagnosis of local recurrence of NPC, a median of 2 years
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Progression-free survival of all patients
Time Frame: Time Frame: From the completion of CIRT, a median of 2 years
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Time Frame: From the completion of CIRT, a median of 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2015
Primary Completion (ACTUAL)
January 1, 2017
Study Completion (ACTUAL)
January 1, 2017
Study Registration Dates
First Submitted
June 11, 2016
First Submitted That Met QC Criteria
June 14, 2016
First Posted (ESTIMATE)
June 15, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 12, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Cisplatin
Other Study ID Numbers
- SPHIC-TR-HNCNS-2015-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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