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Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cetuximab
Cisplatin
Docetaxel
Intensity-modulated radiotherapy
Cisplatin
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Locally advanced, Cetuximab, Weekly cisplatin chemotherapy, Intensity-modulated radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
  2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)
  3. ECOG performance status of 0-1
  4. Life expectancy of more than 6 months
  5. Signed written informed consent
  6. Adequate organ function including the following:

    • Absolute neutrophil count (ANC) >= 1.5 * 109/l
    • Platelets count >= 100 * 109/l
    • Hemoglobin >= 10 g/dl
    • AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
    • Total bilirubin <= 1.5 times institutional ULN
    • Creatinine clearance >= 50 ml/min
    • Serum creatine <= 1 times ULN

Exclusion Criteria:

  1. Evidence of distant metastasis
  2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cisplatin-radiotherapy (CRT)

cetuximab-radiotherapy (ERT)

Arm Description

The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy

The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy

Outcomes

Primary Outcome Measures

Progression-free survival
The time from date of randomization until date of first documented disease progression or death from any cause, assessed up to 3 years.

Secondary Outcome Measures

Overall survival
The time from date of randomization until date of death due to any cause, assessed up to 3 years.
Locoregional recurrence-free survival
The time from date of randomization until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.
Distant metastasis-free survival
The time from date of randomization until date of first documented distant metastasis, assessed up to 3 years.
Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0
Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0
Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
QoL score will be documented on each weekend during the course of radiotherapy
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) at 3 months after completion of radiotherapy

Full Information

First Posted
June 5, 2012
Last Updated
June 6, 2012
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01614938
Brief Title
Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer
Official Title
Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.
Detailed Description
Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui et al. showed that neoadjuvant docetaxel-cisplatin (TP) chemotherapy followed by concurrent chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the 3-year OS without significantly exacerbating the acute toxicities. Moreover, Bonner et al. demonstrated that RT with concurrent Cetuximab significantly improved the 5-year OS and did not increase the treatment induced toxicities when compared with RT alone. Therefore, we initiated this study to compare the efficacy and toxicity of the two regimens, neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin for locally advanced NPC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, Locally advanced, Cetuximab, Weekly cisplatin chemotherapy, Intensity-modulated radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cisplatin-radiotherapy (CRT)
Arm Type
Active Comparator
Arm Description
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
Arm Title
cetuximab-radiotherapy (ERT)
Arm Type
Experimental
Arm Description
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy
Other Intervention Name(s)
IMRT
Intervention Description
a total dose of 66-70.4Gy in 30-32 fractions over 6-6.5 weeks planned to be delivered to the PTV of gross tumor
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3, then 6 cycles of concomitant chemotherapy every week with cisplatin 30 mg/m2 D1
Primary Outcome Measure Information:
Title
Progression-free survival
Description
The time from date of randomization until date of first documented disease progression or death from any cause, assessed up to 3 years.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The time from date of randomization until date of death due to any cause, assessed up to 3 years.
Time Frame
up to 3 years
Title
Locoregional recurrence-free survival
Description
The time from date of randomization until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.
Time Frame
up to 3 years
Title
Distant metastasis-free survival
Description
The time from date of randomization until date of first documented distant metastasis, assessed up to 3 years.
Time Frame
up to 3 years
Title
Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0
Time Frame
1, 2, 3 weeks post-dose
Title
Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0
Time Frame
Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy
Title
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
Description
QoL score will be documented on each weekend during the course of radiotherapy
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) at 3 months after completion of radiotherapy
Time Frame
At 3 months after completion of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3) Stage Ⅲ-ⅣB disease (AJCC/UICC 2009) ECOG performance status of 0-1 Life expectancy of more than 6 months Signed written informed consent Adequate organ function including the following: Absolute neutrophil count (ANC) >= 1.5 * 109/l Platelets count >= 100 * 109/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine <= 1 times ULN Exclusion Criteria: Evidence of distant metastasis Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guopei Zhu, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26163437
Citation
Xu T, Liu Y, Dou S, Li F, Guan X, Zhu G. Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study. Oral Oncol. 2015 Sep;51(9):875-9. doi: 10.1016/j.oraloncology.2015.06.008. Epub 2015 Jul 7.
Results Reference
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Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer

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