Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

• ClinicalTrials.gov Identifier: NCT02012062
• Recruitment Status: Completed
• First Posted: December 16, 2013
• Last Update Posted: April 10, 2019
• Sponsor: Fudan University
• Collaborators: Fujian Province Tumor Hospital; The First Affiliated Hospital of Xiamen University
• Information provided by (Responsible Party): Lin Kong, Fudan University

Tracking Information

• First Submitted Date: December 4, 2013
• First Posted Date: December 16, 2013
• Last Update Posted Date: April 10, 2019
• Actual Study Start Date: July 2012
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 10, 2013): Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities) [ Time Frame: From Day 1 to Day 90 of radiotherapy ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 10, 2013)

• PFS [ Time Frame: 3 years ]
• OS [ Time Frame: 3 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
• Official Title: Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
• Brief Summary: 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.

Detailed Description

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

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Nasopharyngeal Carcinoma

Intervention

• Drug: TPF neoadjuvant chemotherapy
• Drug: Concurrent chemotherapy with cisplatin during radiotherapy
• Drug: Concurrent nimotuzumab during radiotherapy
• Radiation: Radical radiotherapy

Study Arms

• Active Comparator: 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
  Interventions:

  • Drug: TPF neoadjuvant chemotherapy
  • Drug: Concurrent chemotherapy with cisplatin during radiotherapy
  • Radiation: Radical radiotherapy
• Experimental: 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
  Interventions:

  • Drug: TPF neoadjuvant chemotherapy
  • Drug: Concurrent nimotuzumab during radiotherapy
  • Radiation: Radical radiotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2019): 160
• Original Estimated Enrollment (submitted: December 10, 2013): 320
• Actual Study Completion Date: August 2017
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02012062
• Other Study ID Numbers: NPC-IMRT-N
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lin Kong, Fudan University
• Study Sponsor: Fudan University

Collaborators

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

• Investigators: Not Provided
• PRS Account: Fudan University
• Verification Date: April 2019