Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT02801487|
Recruitment Status : Terminated (Slow accrual of patients.)
First Posted : June 15, 2016
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Radiation: Carbon ion radiotherapy (CIRT) Drug: Cisplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||January 1, 2017|
|Actual Study Completion Date :||January 2017|
Experimental: CIRT with concurrent chemo arm
Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m^2, weekly).
Radiation: Carbon ion radiotherapy (CIRT)
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.
- 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 ]
- 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: Time Frame: From the completion of CIRT, a median of 2 years ]
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
|Shanghai Proton and Heavy Ion Center|
|Shanghai, Shanghai, China, 201315|
|Principal Investigator:||Jiade J Lu, MD||Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC|