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A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China


Phase 2
18 Years
69 Years
Open (Enrolling)
Both
Nasopharyngeal Squamous Cell Carcinoma, Toxicity Due to Radiotherapy

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Trial Information

A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China


Nasopharyngeal carcinoma has an unique geographic distribution, and has different
pathological types, natural history, treatment modalities in endemic and non-endemic
regions. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive.
Chemoradiotherapy is the main therapy choice for the locoregionally advanced nasopharyngeal
carcinoma. However,the optimal chemoradiotherapy regimen has not been determined. Many new
drugs including docetaxel and gemcitabine have been incorporated in the induction
chemotherapy phase of NPC. The investigators designed the present study with induction
chemotherapy follow by CCRT for locoregionally advanced NPC in non-endemic Northwest China,
comparing induction chemotherapy regime of TP and GP. The primary objectives were overall
response rate (ORR), acute toxicity, tolerance; second objective were overall survival (OS),
progression free survival (PFS), rate of distant metastases,late adverse events and quality
of life.


Inclusion Criteria:



- Histologically proven WHO II~III native NPC in northwest region of China;

- 18 Years to 70 Years;

- stages III-IVb according to AJCC stage classification(7th edition), no previous
chemotherapy and radiotherapy;

- Performance status: 0-1(ECOG);

- WBC > 4.0X109/L, PLT > 100X109/L, with normal hepatic function(AST, ALT < 2.5 x upper
limit of normal, and bilirubin < 1.5 x upper limit of normal), with normal renal
function (Creatinine < 1.5 x upper limit of normal);

- Ability to comply with trial requirements.

Exclusion Criteria:

- Evidence of metastases by clinical or radiographic examinations;

- History of malignancy;

- 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 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:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate (ORR)

Outcome Time Frame:

3-year

Safety Issue:

No

Principal Investigator

Mei Shi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

department of radiation oncology

Authority:

China: Food and Drug Administration

Study ID:

Mshi

NCT ID:

NCT01596868

Start Date:

May 2012

Completion Date:

May 2015

Related Keywords:

  • Nasopharyngeal Squamous Cell Carcinoma
  • Toxicity Due to Radiotherapy
  • Advanced Nasopharyngeal Carcinoma
  • treatment
  • Northwest China
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Nasopharyngeal Neoplasms

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