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Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

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

Outcome Time Frame:

up to 3 years

Safety Issue:

No

Principal Investigator

Guopei Zhu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ministry of Health

Study ID:

HN201002

NCT ID:

NCT01614938

Start Date:

August 2010

Completion Date:

August 2014

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal carcinoma
  • Locally advanced
  • Cetuximab
  • Weekly cisplatin chemotherapy
  • Intensity-modulated radiotherapy
  • Carcinoma
  • Nasopharyngeal Neoplasms

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