Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guo-Pei Zhu, Fudan University
ClinicalTrials.gov Identifier:
NCT01614938
First received: June 5, 2012
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
 Drug: Cetuximab
Drug: Cisplatin
Drug: Docetaxel
Radiation: Intensity-modulated radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    The time from date of randomization until date of death due to any cause, assessed up to 3 years.

  • Locoregional recurrence-free survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1, 2, 3 weeks post-dose ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 3 months after completion of radiotherapy ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cisplatin-radiotherapy (CRT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
 Drug: Docetaxel
2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
Other Name: Taxotere
Radiation: Intensity-modulated radiotherapy
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
Other Name: IMRT
Drug: Cisplatin
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
Other Name: Platinol
Experimental: cetuximab-radiotherapy (ERT)
The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
 Drug: Cetuximab
400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation
Other Name: Erbitux
Drug: Cisplatin
2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3
Other Name: Platinol
Drug: Docetaxel
2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
Other Name: Taxotere
Radiation: Intensity-modulated radiotherapy
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
Other Name: IMRT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614938

Locations
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Guopei Zhu, M.D. Fudan University
  More Information

No publications provided

Responsible Party: Guo-Pei Zhu, M.D., Associated Professor, Fudan University
ClinicalTrials.gov Identifier: NCT01614938     History of Changes
Other Study ID Numbers: HN201002
Study First Received: June 5, 2012
Last Updated: June 6, 2012
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
Nasopharyngeal carcinoma
Locally advanced
Cetuximab
Weekly cisplatin chemotherapy
Intensity-modulated radiotherapy

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
 Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013