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Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534585
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Haihua Yang, Taizhou Hospital

Brief Summary:
Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer. Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC. However, concurrent chemoradiotherapy increased significantly local and systemic toxic effects, which may preclude many patients from proceeding with combined therapy. The epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter survival following chemoradiotherapy in locoregionally advanced NPC. And some basic researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line. Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in patients with NPC. This regimen is of great interest and it has potential to alleviate the adverse effects, improve patient compliance and better therapeutic ratio.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Icotinib Radiation: intensity-modulated radiotherapy Drug: Paclitaxel and Cisplatin Other: Quality of life Genetic: Epidermal growth factor receptor status Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Icotinib

    Oral Icotinib begins on day 1 and continues until completion of radiotherapy. Phase I:The initial plan is to accrue 6 patients to each dose level (125mg, qd and bid and tid) in each cohort. If one or none of six patients have dose limiting toxicity (DLT), then escalation will proceed. If DLT occurs in two or more patients at a dose level, then escalation will be stopped. The dose level below that at which two of six patients experience a DLT is defined as the maximum-tolerated dose. A minimum of 4 weeks of observation is required after completion of radiation within each Icotinib dose level before accrual to the next level.

    Phase II:According to the maximum tolerated dose, 50 patients will been recruited.

    Other Name: Conmana
  • Radiation: intensity-modulated radiotherapy
    The nasopharyngeal regions and upper neck with IMRT plans will be generated and approved for each patient, whereas the low-neck and supraclavicular regions will be used with a conventional anterior field. A total of 70-76Gy at 2.12-2.3Gy/fraction/d will be given to the GTVnx, the GTVnd will receive 66-70Gy at 2.0-2.12Gy/fraction/d, the CTV1 will receive 60-66Gy at 1.8-2.0Gy/fraction/d, and the CTV2 received 56-60Gy at 1.7-1.8Gy/fraction/d with IMRT. The low-neck and supraclavicular regions will receive 50-60Gy at 2.0Gy/fraction/d with conventional radiotherapy. Target prescription dose and critical structures limit dose are planned according to the RTOG0225 trial.
    Other Name: IMRT
  • Drug: Paclitaxel and Cisplatin
    AC that consisted of two cycles of paclitaxel 135 mg/m2 on day 1 plus cisplatin 30 mg/m2 on days 1-3 will start 4 weeks after the end of CRT.
  • Other: Quality of life
    The EORTC QLQ-C30 and H&N35 of the Chinese version, which is obtained from the Quality of Life Unit, EORTC Data Center in Brussels, Belgium, is available and easily completed by our patients are chosen for this study. Patients will complete the questionnaire before treatment and after treatment and one month after treatment and three months after treatment and one year after treatment.
    Other Name: QoL
  • Genetic: Epidermal growth factor receptor status
    EGFR expression and mutation before treatment.
    Other Name: EGFR

Primary Outcome Measures :
  1. Phase I: the maximum tolerated dose of Icotinib in combination with IMRT for NPC [ Time Frame: 30 days ]
  2. Phase II: 2 years locoregional control rate [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. The overall response rate (complete and partial response) [ Time Frame: 1 month following treatment and then every 3 months ]
  2. The acute and late toxicity profile associated with the study regimen [ Time Frame: 1 month following treatment and then every 3 months ]
  3. The duration of control of locoregional disease [ Time Frame: 1 month following treatment and then every 3 months ]
  4. Overall survival, disease-free survival, and distant relapse rates [ Time Frame: At time of locoregional disease progression ]
  5. EGFR status in tissue and blood before treatment [ Time Frame: 2 week of pretreatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histological proof of squamous carcinoma of the nasopharynx.
  2. Patients must have ECOG Performance Status of 0-1.
  3. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of >/= 1500 cells/mm3, platelet count of >/= 100,000 cells/mm3; adequate hepatic function with bilirubin </= 1.5mg/dl, AST and ALT </= 2x the upper limit of normal; serum creatinine </= 1.5mg/dl, creatinine clearance >/= 50 ml/min and INR 0.8 - 1.2.
  4. Patients must sign a study specific informed consent form prior to study entry.

Exclusion Criteria:

  1. Evidence of metastases by clinical or radiographic examinations.
  2. History of malignancy other than non-melanoma skin cancer.
  3. Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.
  4. Patients with uncontrolled intercurrent disease.
  5. Patients with currently active malignancy.
  6. Pregnant or lactating women Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01534585

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China, Zhejiang
Taizhou Hospital, Wenzhou Medical College
Taizhou, Zhejiang, China, 317000
Sponsors and Collaborators
Taizhou Hospital
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Study Director: Haihua Yang, MD. Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Study Chair: Wei Hu, MD. Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Principal Investigator: Wei Wang, BS Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Principal Investigator: Chao Zhou, MD. Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.

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Responsible Party: Haihua Yang, Director of Radiotherapy Dept, Taizhou Hospital Identifier: NCT01534585     History of Changes
Other Study ID Numbers: YHH-201201
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Haihua Yang, Taizhou Hospital:
nasopharyngeal carcinoma(NPC)
Intensity Modulation Radiation Therapy(IMRT)

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action