Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00547157
First received: October 18, 2007
Last updated: July 10, 2014
Last verified: July 2014

October 18, 2007
July 10, 2014
November 2007
December 2011   (final data collection date for primary outcome measure)
Local Regional Control Rate at 2 Years [ Time Frame: from study day 1 to 2 years ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator's assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).
Efficacy: LRC rate at 2 years
Complete list of historical versions of study NCT00547157 on ClinicalTrials.gov Archive Site
  • Duration of Local Regional Control [ Time Frame: maximum follow up time 46.2 months ] [ Designated as safety issue: No ]
    Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)
  • Progression-free Survival [ Time Frame: maximum follow up time 46.2 months ] [ Designated as safety issue: No ]
    Time from first dose date till disease progression or death
  • Overall Survival [ Time Frame: maximum follow up time 46.2 months ] [ Designated as safety issue: No ]
    Time from first dose date to death
  • ORR by 6 Months - Central [ Time Frame: From randomization to 6 months ] [ Designated as safety issue: No ]
    ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.
  • CRR by 6 Months - Central [ Time Frame: From randomization till 6 months ] [ Designated as safety issue: No ]
    CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.
Efficacy: PFS, OS, duration of LRC, LRC at 6 months and 1 year, rate of CR by 6 months, ORR by 6 months, Safety
Not Provided
Not Provided
 
Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.

Primary Objective: To estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN).

Secondary Objectives: To estimate the difference between 2 treatment regimens (CRT vs PRT) on other measures of clinical benefit, including LRC, overall response rate (ORR), progression-free survival (PFS), overall survival (OS); and safety.

Tertiary Objectives: To estimate the difference in health-related quality of life (HRQoL) and performance status in subjects receiving PRT or CRT.

Exploratory Objectives: To investigate potential biomarker development based on assessment of blood and tumor and the proposed mechanism of actions of study drugs. In addition, to investigate the effect of genetic variation in cancer genes and drug target genes on SCCHN and subject response to study drugs (separate informed consent required).

Hypothesis: A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.

Study Design: This is a phase 2, open-label, randomized, multicenter study. Eligible subjects will be randomized in a 2:3 ratio to either of the following regimens:

Arm 1 CRT:

  • Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
  • Cisplatin: 100 mg/m2 (given on days 1 and 22 of RT) or

Arm 2 PRT:

  • Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
  • Panitumumab: 9.0 mg/kg Q3W (given on days 1, 22, and 43 of RT)
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Head and Neck Cancer
  • Oncology
  • Squamous Cell Carcinoma
  • Drug: Panitumumab
    Arm 2 consists of panitmumab plus RT
    Other Name: Panitumumab (drug)
  • Drug: Cisplatin
    Cisplatin
    Other Name: Cisplatin (Chemotherapy)
  • Active Comparator: ARM 1 CRT
    Cisplatin plus RT
    Intervention: Drug: Cisplatin
  • Experimental: ARM 2 PRT
    Panitumumab plus RT
    Intervention: Drug: Panitumumab
Cmelak A, Giralt J, Mesía R, Oliner K, VanderWalde A, Zhang A, Trigo JM, Nuyts S, Ozsahin M, Skladowski K, Hatoum G, Daisne J-F, Ancona ACY.A Phase 2, Randomized Trial (CONCERT-2) of Panitumumab Plus Radiotherapy Compared With Chemoradiotherapy in Patients With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck.Journal-001615;

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1 Bidimensionally measurable disease >/= 10 mm in at least 1 dimension

Exclusion Criteria:

NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for >/= 3 years NO Prior treatment for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) NO Major surgery </= 28 days before randomization or minor surgery </= 14 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00547157
20062079, CONCERT2
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP