Evaluation of the association of removable partial denture supported by implants distal extension.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-45nf55
• Date of registration: 23/04/2012
• Primary sponsor: Neodent - Brazil
• Public title: Evaluation of the association of removable partial denture supported by implants distal extension.
• Scientific title: Evaluation of the remaining alveolar ridge height, the masticatory efficiency and success rate of implants in patients with Kennedy Class I arches rehabilitated with removable partial dentures supported by implants.
• Date of first enrolment: 15/01/2011
• Target sample size: 60
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-45nf55/
• Study design: Clinical trial, two arms, open, nonrandomized controlled trial.

Countries of recruitment

Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Guatemala, India, Indonesia, Italy, Korea, Democratic People's Republic of, Lebanon, Malaysia, Malta, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Province of China, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Minori Koshiji
• Affiliation: ImClone Systems Incorporated

• Name: Rodrigo Guimarães
• Affiliation: Quintiles Brasil Ltda

Key inclusion & exclusion criteria

Inclusion criteria: Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma; metastatic disease or locally recurrent; unresectable disease with measurable lymph node metastases; measurable disease and/or evaluable disease. ; experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy; disease not amenable to potentially curative resection; patient is over 18 years old; there is no maximum age for enrollment in the study; patient has a life expectancy of 12 or more weeks; patient resolution to Grade = 1 (or to Grade = 2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.02, of all significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia); Eastern Cooperative Oncology Group Performance Status score of 0-1; adequate hepatic function; adequate renal function; urinary protein is = 1+ on dipstick or routine urinalysis; adequate hematologic function; adequate coagulation function. ; if the patient has received prior anthracycline therapy as part of his or her first-line regimen, the patient is able to engage in ordinary physical activity without significant fatigue or dyspnea; patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods); female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization; able to provide informed written consent and is amenable to compliance with protocol schedules and testing.
Exclusion criteria: Brain or leptomeningeal metastases. Experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization; experienced any arterial thromboembolic events within 6 months prior to randomization; ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator; ongoing or active psychiatric illness or social situation that would limit compliance with study requirements; uncontrolled or poorly-controlled hypertension; patient has a serious or nonhealing wound, ulcer, or bone fracture. Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to randomization; received any investigational therapy within 1 year prior to randomization; undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization; received prior therapy with an agent that directly inhibits VEGF or VEGFR-2 activity, or any antiangiogenic agent. Receiving chronic antiplatelet therapy; known allergy to any of the treatment components; pregnant or lactating; known to be positive for infection with the human immunodeficiency virus; known alcohol or drug dependency; concurrent active malignancy other than adequately-treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm; patient with previous history of malignancy is eligible, provided that he/she has been free of disease for > 3 years.

Age minimum: 18Y
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

C00-D48

Partially edentulous patients with absence of posterior teeth have less support structures (teeth and oral mucosa) with different degrees of resilience causing difficulties in the prosthetic rehabilitation on the retention, stability and comfort of removable partial dentures. Removable Partial Denture, Mastication
C04.557.470.200.025
C04.588.274.476.767
C04.557.470.200
C04.588.274
C04.588.274.476

Intervention(s)

The sample will be divided into two groups of thirty patients each: group 1 (control group) whose patients will be rehabilitated with removable partial dentures convencioanl group 2 (treated group, in which patients receive dental implants (implants WAS Neodoent, Curitiba, Brazil ) installed (one on each side in the region of the 2nd molar), the removable partial dentures (RPD) will be adapted for association with these implants.
The analysis of adaptation of the prosthesis and masticatory efficiency will be held in three separate stages. The first (T1), immediately after the installation of removable partial dentures (RPDs) in both groups, the second (T2), two months after the use of PRPs for the control group and treated group, the latter still prostheses not be effectively supported on implants (implants will meet in healing period), the third (T3), six months after the use of prostheses in the control group and treated group.

Primary Outcome(s)

To evaluate the overall survival (OS) of patients with metastatic gastric cancer (including adenocarcinomas of the gastroesophageal junction [GEJ]) following disease progression on first-line platinum- or fluoropyrimidine-containing combination chemotherapy who undergo treatment with the MAb IMC-1121B plus BSC versus placebo plus BSC.

Secondary Outcome(s)

Secondary efficacy endpoints will include the evaluation of the progression-free survival (PFS), including 12-week PFS rate, associated with IMC-1121B versus placebo; the objective response rate (ORR); the duration of response; the quality of life (QoL); the safety profile of IMC-1121B; the pharmacodynamic profile of IMC-1121B and the immunogenicity of IMC-1121B.

Secondary ID(s)

2008-005964-15

25000.035555/2010-83

BB IND 11856

CAAE 0037.1.083.000-10

CEP 128/09 - Comunicação 027/2012/COEP/UNIVATES

CEP 128/09 - Ofício 20/COEP/UNIVATES

CEP 128/09 - Resolução 118/COEP/UNIVATES

IMCLCP12-0715 (I4T-IE-JVBD)

LY3009806

NTC00917384

Parecer 270/2010

Registro 15836

Source(s) of Monetary Support

ImClone Systems Incorporated - New Jersey, United States

Secondary Sponsor(s)

PAREXEL International - São Paulo, SP, Brazil

Quintiles Brasil Ltda - São Paulo, SP, Brazil