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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cetuximab

Cisplatin

Docetaxel

Intensity-modulated radiotherapy

Cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Locally advanced, Cetuximab, Weekly cisplatin chemotherapy, Intensity-modulated radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
Stage Ⅲ-ⅣB disease (AJCC/UICC 2009)
ECOG performance status of 0-1
Life expectancy of more than 6 months
Signed written informed consent
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:

Evidence of distant metastasis
Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
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

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cisplatin-radiotherapy (CRT)

cetuximab-radiotherapy (ERT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

The time from date of randomization until date of death due to any cause, assessed up to 3 years.

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.

Distant metastasis-free survival

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

Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the concurrent treatment according to CTCAE v4.0

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

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

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

Full Information

NCT ID

NCT01614938

First Posted

June 5, 2012

Last Updated

June 6, 2012

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01614938

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2010 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, Locally advanced, Cetuximab, Weekly cisplatin chemotherapy, Intensity-modulated radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cisplatin-radiotherapy (CRT)

Arm Type

Active Comparator

Arm Description

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

Arm Title

cetuximab-radiotherapy (ERT)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiotherapy

Other Intervention Name(s)

IMRT

Intervention Description

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

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

The time from date of randomization until date of death due to any cause, assessed up to 3 years.

Time Frame

up to 3 years

Title

Locoregional recurrence-free survival

Description

The time from date of randomization until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.

Time Frame

up to 3 years

Title

Distant metastasis-free survival

Description

The time from date of randomization until date of first documented distant metastasis, assessed up to 3 years.

Time Frame

up to 3 years

Title

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

Title

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

Title

Time Frame

Every 3 months during the first 2 years, then every 6 months during year 3 after completion of radiotherapy

Title

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

Description

QoL score will be documented on each weekend during the course of radiotherapy

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3) Stage Ⅲ-ⅣB disease (AJCC/UICC 2009) ECOG performance status of 0-1 Life expectancy of more than 6 months Signed written informed consent 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: Evidence of distant metastasis Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guopei Zhu, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

26163437

Citation

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.

Results Reference

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

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