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A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma


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

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Trial Information

A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma


Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three
subgroups, the data came from conventional radiotherapy era showed that the prognosis of
this three subgroups were different, the N1 groups suffered more distant metastasis than N0
group, and some literature showed that combined chemotherapy with radiotherapy in stage II
patients can improve the treatment results.

Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of
nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality
of life in nasopharyngeal through salivary gland preservation.

Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of
stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup)
nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.


Inclusion Criteria:



- pathological confirmed squamous cell carcinoma, WHO II-III type,

- clinical stage II (UICC 7th edition, 2009)

- Karnovsky performance score > 70

- first course of radiotherapy, without radiotherapy and chemotherapy history for other
head and neck cancer.

- anticipated life span more than 6 month

- Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L

- liver and renal function under the 1.25 normal upper limit

- with written consent information

Exclusion Criteria:

- have other cancer history

- have chemotherapy history

- have radiotherapy history

- have head and neck surgery history(exclusion lymph node biopsy)

- evidence showed distant metastasis or other cancer

- other severe medical comorbidity

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:

Acute toxicities

Outcome Description:

Acute toxicity will be measured by CTCAE3.0

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Li Gao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Sciences

Authority:

China: Ministry of Health

Study ID:

CH-HN-001

NCT ID:

NCT01187238

Start Date:

July 2010

Completion Date:

October 2015

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal carcinoma
  • Stage II
  • Intensity-modulated radiotherapy
  • Concurrent chemoradiotherapy
  • Cisplatin
  • Carcinoma
  • Nasopharyngeal Neoplasms

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