Dose Escalation of Lobaplatin Concurrent With IMRT for the Treatment of NPC: A Phase I Clinical Trial
Condition: Acute Toxic Effects; Tumor Responses
Study type: Interventional
Phase: Phase 1

Summary: 
      Nasopharyngeal carcinoma (NPC) is a common malignant tumor in Southern China area, which is
      characterized by obvious regional characteristics and "Guangdong cancer". Radiotherapy is the
      main treatment for locally advanced nasopharyngeal carcinoma. In recent years, chemotherapy
      has improved the short-term and long-term survival of patients with locally advanced
      nasopharyngeal carcinoma.

      Lobaplatin is the third generation platinum anticancer drugs, mechanism of action and
      traditional cisplatin is similar, mainly formed by the Pt-GG and Pt-AG chain cross connect,
      replication and transcription process blocks of deoxyribonucleic acid(DNA), thereby
      interfering with tumor cell cycle. The damage of DNA induced by lobaplatin can influence the
      expression of tumor cell specific genes. Due to the different structure of lobaplatin and no
      cross resistance to cisplatin in the study showed that, compared with cisplatin with
      gastrointestinal reaction more mild, and no cisplatin common liver and kidney toxicity,
      neurotoxicity and ototoxicity, in some tumors have a better adaptability; but compared with
      cisplatin had more severe bone marrow suppression this, offset some of the advantages of
      lobaplatin in a certain extent. At present, the clinical indications for the treatment of
      such diseases include head and neck cancer, breast cancer, gastrointestinal cancer,
      gynecologic malignant tumor and non small cell lung cancer. Tian Ying confirmed that
      lobaplatin has obvious cytotoxic effect on nasopharyngeal carcinoma cells, in a concentration
      dependent manner, the mechanism for the dual role, namely block at lower concentration of
      cells in G2 phase and induce apoptosis at higher concentration, provide the possibility for
      clinical treatment of nasopharyngeal carcinoma for lobaplatin; there are a number of clinical
      study confirmed that lobaplatin chemoradiotherapy for locally advanced nasopharyngeal
      carcinoma with cisplatin approximation. But at present, there is no report on the dose and
      tolerability of concurrent radiotherapy for nasopharyngeal carcinoma.

      Therefore, a dose escalation trial was conducted to determine maximum tolerated dose of
      lobaplat in as a single agent combined with concurrent intensity-modulated radiotherapy in a
      Chinese population with locoregionally advanced NPC.
    


Intervention name(s): Lobaplatin; linear accelerator
Intervention type(s): Drug; Device
Intervention description(s): Lobaplatin for Injection; Medical linear accelerator
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The initial dose was 25mg/m2 on d1,d22,d43 for 1 cycles; if no obvious toxicity was observed,follow 30mg/m2,35mg/m2,40mg/m2,45mg/m2, and 50mg/m2 gradients into the next dose group until the maximum tolerated dose or 50mg/m2
Masking: Single (Investigator)
Primary purpose: Treatment