Skip to main content
OpenTrials
Completed

NCT Number: NCT01187238

The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

The purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cisplatin

Drug

in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7

Other names: DDP

Primary outcomes

  1. Acute toxicities

    Time frame: 2 years

    Acute toxicity will be measured by CTCAE3.0

Secondary outcomes

  1. Long term treatment results

    Time frame: 5 years

    1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2017
First posted
Aug 24, 2010
Registry last updated
Jul 16, 2020

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.

Published trials that share one or more normalized conditions with this study.