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


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

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


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 the upper limit of normal; serum creatinine /= 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: the maximum tolerated dose of Icotinib in combination with IMRT for NPC

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Haihua Yang, MD.

Investigator Role:

Study Director

Investigator Affiliation:

Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.

Authority:

China: Food and Drug Administration

Study ID:

YHH-201201

NCT ID:

NCT01534585

Start Date:

February 2012

Completion Date:

February 2015

Related Keywords:

  • Nasopharyngeal Carcinoma
  • nasopharyngeal carcinoma(NPC)
  • Icotinib
  • Intensity Modulation Radiation Therapy(IMRT)
  • Carcinoma
  • Nasopharyngeal Neoplasms

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