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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Cetuximab; Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01614938

HN201002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

cisplatin-radiotherapy (CRT)

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel

Radiation: Intensity-modulated radiotherapy

Drug: Cisplatin

Drug: Cisplatin

cetuximab-radiotherapy (ERT)

Experimental group

Description:

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

Treatment:

Drug: Docetaxel

Radiation: Intensity-modulated radiotherapy

Drug: Cisplatin

Drug: Cetuximab

Drug: Cisplatin