Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Mitogens

Panitumumab

Antineoplastic Agents, Immunological

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)

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

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).

Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)

Time from first dose date till disease progression or death

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 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.

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One Subject who was randomized to Panitumumab+Radiotherapy but received Chemotherapy+Radiotherapy was summarized under Chemotherapy+Radiotherapy arm. So the number of participants under Chemotherapy+Radiotherapy arm is 62 (61+1).

Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy

Panitumumab Plus Radiotherapy

Chemotherapy Plus Radiotherapy

Panitumumab Plus Radiotherpy

Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy

Chemoradiotherapy

Total

Age, Continuous

Sex: Female, Male

Asian

Black or African American

White

Hispanic or Latino

Race/Ethnicity, Customized

IMRT

3D-CRT

Missing

Radiotherapy Delivery Modality

Oropharynx/Larynx

Oral Cavity/Hypopharynx

Primary Tumor Site

N0: No regional lymph node involvement; N+: Regional lymph node involvement

Nodal Status

T1-3

Tumor stage is determined according to TNM staging system. The tumor, node, and metastasis (TNM) staging system integrates clinical information, including that derived from endoscopy and radiological evaluation. Together the TNM classifications determine the overall clinical stage (I, II, III or IV).

Tumor Stage

Study Director

Local Regional Control Rate at 2 Years

Duration of Local Regional Control

Progression-free Survival

Overall Survival

Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck	NCT00547157	Cancer Head and Neck C... Oncology Squamous Cell C...	Panitumumab Cisplatin	18 Years -	Amgen
Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck	NCT00547157	Cancer Head and Neck C... Oncology Squamous Cell C...	Panitumumab Cisplatin	18 Years -	Amgen

Spots Global Cancer Trial Database for locally advanced head & neck cancer