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NCT Number: NCT01534585

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Taizhou Hospital, Wenzhou Medical College

Taizhou, Zhejiang, 317000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histological proof of squamous carcinoma of the nasopharynx.
  • Patients must have ECOG Performance Status of 0-1.
  • 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.
  • Patients must sign a study specific informed consent form prior to study entry.

Exclusion criteria

  • Evidence of metastases by clinical or radiographic examinations.
  • History of malignancy other than non-melanoma skin cancer.
  • 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.
  • Patients with uncontrolled intercurrent disease.
  • Patients with currently active malignancy.
  • 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.

Treatment and study plan

Icotinib

Drug

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 names: Conmana

Intensity-Modulated Radiotherapy

Radiation

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 names: IMRT

Paclitaxel and cisplatin

Drug

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.

Quality of life

Other

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 names: QoL

Epidermal growth factor receptor status

Genetic

EGFR expression and mutation before treatment.

Other names: EGFR

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Taizhou Hospital

Other

Registry information

Official study title

Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Feb 16, 2012
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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