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

NCT00547157 | Completed Phase 2 Results DMC

• 2 other identifiers: 20062079CONCERT2
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer; Head and Neck Cancer; Oncology; Squamous Cell Carcinoma

Keywords

head and neck; squamous cell carcinoma; radiotherapy; chemoradiotherapy; panitumumab; locally advanced head & neck cancer; EGFr; epidermal growth factor receptor; SCCHN; locally advanced SCCHN; HNC; epidermal growth factor

Outcome Measures

Primary Outcomes (1)

• Local Regional Control Rate at 2 Years

  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).

  from study day 1 to 2 years

Secondary Outcomes (5)

• Duration of Local Regional Control

  maximum follow up time 46.2 months

• Progression-free Survival

  maximum follow up time 46.2 months

• Overall Survival

  maximum follow up time 46.2 months

• ORR by 6 Months - Central

  From randomization to 6 months

• CRR by 6 Months - Central

  From randomization till 6 months

Study Arms (2)

ARM 1 CRT

ACTIVE COMPARATOR

Cisplatin plus RT

Drug: Cisplatin

ARM 2 PRT

EXPERIMENTAL

Panitumumab plus RT

Drug: Panitumumab

Interventions

Panitumumab DRUG

Arm 2 consists of panitmumab plus RT

Also known as: Panitumumab (drug)

ARM 2 PRT

Cisplatin DRUG

Cisplatin

Also known as: Cisplatin (Chemotherapy)

ARM 1 CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• Giralt J, Trigo J, Nuyts S, Ozsahin M, Skladowski K, Hatoum G, Daisne JF, Yunes Ancona AC, Cmelak A, Mesia R, Zhang A, Oliner KS, VanderWalde A. Panitumumab plus radiotherapy versus chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-2): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):221-32. doi: 10.1016/S1470-2045(14)71200-8. Epub 2015 Jan 15.

  PMID: 25596659 BACKGROUND

• Mesia R, Henke M, Fortin A, Minn H, Yunes Ancona AC, Cmelak A, Markowitz AB, Hotte SJ, Singh S, Chan AT, Merlano MC, Skladowski K, Zhang A, Oliner KS, VanderWalde A, Giralt J. Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):208-20. doi: 10.1016/S1470-2045(14)71198-2. Epub 2015 Jan 15.

  PMID: 25596660 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms; Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Panitumumab; Pharmaceutical Preparations; Cisplatin; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 22, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 15, 2017
• Results First Posted: May 23, 2014

Record last verified: 2017-02