Brief Summary

Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline

Completed

Started Apr 2010

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach

1 country

17 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.5 years study duration

Study Start

First participant enrolled

April 1, 2010

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed

7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

April 7, 2020

Completed

Last Updated

April 7, 2020

Status Verified

March 1, 2020

Enrollment Period

8 years

First QC Date

April 23, 2010

Results QC Date

January 3, 2020

Last Update Submit

March 25, 2020

Conditions

Head and Neck Cancer

Keywords

Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

2 Year Progression Free Survival Rate
Time to disease progression or death from any cause--2 year rate
2 years

Secondary Outcomes (8)

Number of Participants With Toxicity
4 years
Site of Progression: Local-regional
4 years
Site of Progression: Distant
4 years
Site of Progression: Unknown
4 years
Second Primary Tumor
4 years
+3 more secondary outcomes

Study Arms (2)

Everolimus (RAD001)

EXPERIMENTAL

Subjects will receive Everolimus 10 mg daily

Drug: Everolimus (RAD 001)

Placebo

EXPERIMENTAL

Subjects will receive double-blind placebo

Other: Placebo

Interventions

Everolimus (RAD 001)DRUG

10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).

Everolimus (RAD001)

PlaceboOTHER

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.
years or older.
Performance status 70% or better.
Adequate marrow, renal and liver function (will be tested by labs). \_ Able give consent.

You may not qualify if:

Currently receiving anti-cancer treatment.
Major surgery or traumatic injury within 4 weeks.
Radiotherapy related toxicities.
Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors
Receiving other investigational drugs.
Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .
Show evidence of disease (cancer).
Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.
Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.
Active, uncontrolled severe infections
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
Known History of HIV positivity.
Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.
Patients with an active, bleeding diathesis.
+7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Chicagolead
Novartis Pharmaceuticalscollaborator

Study Sites (17)

University of Miami

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois-Chicago

Chicago, Illinois, 60612, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Ingalls Cancer Research Center

Harvey, Illinois, 60426, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Louisianna State University

Shreveport, Louisiana, 71130, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Related Publications (1)

Nathan CO, Hayes DN, Karrison T, Harismendy O, Flores JM, Moore-Medlin T, Vokes EE, Gutkind JS, Neupane P, Mills G, Sargi Z, Seiwert T, Grilley-Olson J, Day T, Gillison M, Wade JL, Feldman L, Jha G, Kozloff M, O'Leary M, Worden FP, Cohen EEW. A Randomized Multi-institutional Phase II Trial of Everolimus as Adjuvant Therapy in Patients with Locally Advanced Squamous Cell Cancer of the Head and Neck. Clin Cancer Res. 2022 Dec 1;28(23):5040-5048. doi: 10.1158/1078-0432.CCR-21-4290.
PMID: 36194164DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms, Squamous Cell

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title: Everett Vokes, MD
Organization: University of Chicago

Study Officials

Tanguy Seiwert, M.D.
The University of Chicago Medical Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 27, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2018

Study Completion

October 1, 2018

Last Updated

April 7, 2020

Results First Posted

April 7, 2020

Record last verified: 2020-03

Locations

US(17)

Study Stopped

Everolimus Versus Placebo in Head and Neck Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Everolimus (RAD001)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Everolimus (RAD001)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations