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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01614938
• Other study ID #: HN201002
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 5, 2012
• Last updated: June 6, 2012
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: June 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)

2. Stage ?-?B 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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Cetuximab
400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation
• Cisplatin
2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3
• Docetaxel
2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1

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

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 years	No
Secondary	Overall survival	The time from date of randomization until date of death due to any cause, assessed up to 3 years.	up to 3 years	No
Secondary	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.	up to 3 years	No
Secondary	Distant metastasis-free survival	The time from date of randomization until date of first documented distant metastasis, assessed up to 3 years.	up to 3 years	No
Secondary	Number of participants with hematologic toxicity events occurred during two cycles of neoadjuvant chemotherapy according to CTCAE v4.0		1, 2, 3 weeks post-dose	Yes
Secondary	Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0		participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Yes
Secondary	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		Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy	Yes
Secondary	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	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	No
Secondary	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		At 3 months after completion of radiotherapy	No