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OpenTrials
Completed

NCT Number: NCT02012062

Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.

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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 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

About this study

Scheme:

Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

  • Arm Cisplatin:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT

  • Arm nimotuzumab:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
  • Stage III and IVA/B NPC patients
  • KPS >70
  • Age between 18-70
  • AGC > 2000, platelets > 100,000, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min

Exclusion criteria

  • Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
  • Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
  • Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
  • Prior radiation treatment to the head and neck or any prior chemotherapy

Treatment and study plan

TPF neoadjuvant chemotherapy

Drug

Concurrent chemotherapy with cisplatin during radiotherapy

Drug

Concurrent nimotuzumab during radiotherapy

Drug

Radical radiotherapy

Radiation

Primary outcomes

  1. Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)

    Time frame: From Day 1 to Day 90 of radiotherapy

Secondary outcomes

  1. PFS

    Time frame: 3 years

  2. OS

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Fujian Province Tumor Hospital
  • The First Affiliated Hospital of Xiamen University

Registry information

Official study title

Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Dec 16, 2013
Registry last updated
Apr 10, 2019

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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