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

NCT ID: NCT01614938

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cisplatin-radiotherapy (CRT)

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

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1

Intensity-modulated radiotherapy

Intervention Type: RADIATION

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

Cisplatin

Intervention Type: DRUG

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

cetuximab-radiotherapy (ERT)

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

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation

Cisplatin

Intervention Type: DRUG

2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3

Docetaxel

Intervention Type: DRUG

2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1

Intensity-modulated radiotherapy

Intervention Type: RADIATION

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

Interventions

Cetuximab

400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation

Intervention Type: DRUG

Cisplatin

2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3

Intervention Type: DRUG

Docetaxel

2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1

Intervention Type: DRUG

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

Intervention Type: RADIATION

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

Intervention Type: DRUG

Other Intervention Names

Erbitux; Platinol; Taxotere; IMRT; Platinol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Guo-Pei Zhu

M.D., Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guopei Zhu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26163437 (View on PubMed)

Other Identifiers

HN201002

Identifier Type: -

Identifier Source: org_study_id