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Search / Trial NCT02801487

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

Launched by SHANGHAI PROTON AND HEAVY ION CENTER · Jun 14, 2016

Trial Information

Current as of July 21, 2025

Terminated

Keywords

Carbon Ion Therapy Concurrent Chemoradiotherapy

ClinConnect 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 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 ter...

Gender

ALL

Eligibility 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

About Shanghai Proton And Heavy Ion Center

The Shanghai Proton and Heavy Ion Center is a leading clinical trial sponsor dedicated to advancing cancer treatment through innovative radiation therapy techniques. With a focus on proton and heavy ion therapies, the center aims to enhance the precision and effectiveness of cancer care while minimizing side effects. Equipped with state-of-the-art technology and a multidisciplinary team of experts, the center conducts rigorous clinical research to evaluate the safety and efficacy of novel treatment modalities, ultimately striving to improve patient outcomes and contribute to the global body of oncology knowledge.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Jiade J Lu, MD

Principal Investigator

Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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