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- Ensaio Clínico NCT00081224
Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
A Phase II Trial Of Celecoxib (Celebrex) And Capecitabine (Xeloda) Combined With Pelvic Irradiation As Neoadjuvant Treatment Of Stage II or III Adenocarcinoma Of The Rectum
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may also make tumor cells more sensitive to chemotherapy and radiation therapy. Giving celecoxib with capecitabine and radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving neoadjuvant celecoxib together with capecitabine and pelvic irradiation works in treating patients with stage II or stage III adenocarcinoma (cancer) of the rectum.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
Primary
- Determine the pathological complete response rate in patients with stage II or III adenocarcinoma of the rectum treated with neoadjuvant celecoxib and capecitabine in combination with pelvic irradiation.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
- Determine the rectal function of patients treated with this regimen.
- Determine the time to recurrence or progression and survival time of patients treated with this regimen.
- Correlate cellular and molecular markers in pretreatment tumor samples with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks.
- Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy.
- Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically confirmed rectal adenocarcinoma
- Clinical stage T3, N0, M0 OR any T, N1-3, M0 disease
Treatment with neoadjuvant chemotherapy and pelvic radiotherapy is indicated
- All disease must be encompassable within standard pelvic radiotherapy fields
- Distal border of the tumor must be at or below* the peritoneal reflection, defined as within 12 cm of the anal verge by endoscopy NOTE: *If a portion of the tumor is below the peritoneal reflection at the time of surgery, patients are eligible regardless of the distance of the tumor determined at endoscopy
Tumor must be determined to be clinically resectable
- Tumor may not be clinically fixed
- Negative margins by routine examination of an unanesthetized patient
- Transmural penetration of tumor through the muscularis propria by CT scan, endorectal ultrasound, or MRI
No distant metastatic disease
No evidence of tumor outside the pelvis, including any of the following:
- Metastatic inguinal lymphadenopathy
- Peritoneal seeding
- Liver metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 6 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Alkaline phosphatase ≤ 4 times ULN if AST < ULN
Renal
- Creatinine clearance ≥ 30 mL/min
- No renal impairment
Cardiovascular
- No congestive heart failure
- No symptomatic coronary artery disease
- No uncontrolled cardiac arrhythmias
- No myocardial infarction
- No history of transient ischemic attacks or stroke
- No other clinically significant cardiac disease
Gastrointestinal
- No bleeding peptic ulcer disease within the past 12 months
- No lack of physical integrity of the upper gastrointestinal tract
- No malabsorption syndrome
- No active inflammatory bowel disease
- Must be able to swallow study drugs
Other
- No dihydropyrimidine dehydrogenase deficiency
- No history of uncontrolled seizures
- No CNS disorders
- No clinically significant psychiatric illness that would preclude study compliance or giving informed consent
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No known sensitivity to NSAIDs, sulfonamides, or aspirin
- No other serious medical illness that would preclude study treatment
- No other conditions that would preclude study participation
- Must be able to tolerate major surgery that may include abdominal-perineal resection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior systemic anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to the pelvis
Surgery
- See Disease Characteristics
- More than 3 weeks since prior major surgery and recovered
Other
- At least 7 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin
- No other concurrent investigational drugs
- No other concurrent anticancer treatment
- No concurrent NSAIDs
- No concurrent primary prophylactic therapy for hand-foot syndrome
- No concurrent loperamide prophylaxis for diarrhea
- No concurrent sorivudine or brivudine
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: celecoxib + capecitabine + radiation + surgery
Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks. Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy. Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Proportion of successes
Prazo: Up to 5 years
|
Up to 5 years
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Tempo de sobrevivência
Prazo: Até 5 anos
|
Até 5 anos
|
Sobrevivência
Prazo: Até 5 anos
|
Até 5 anos
|
Time-to event analyses
Prazo: Up to 5 years
|
Up to 5 years
|
Time to disease progression/recurrence
Prazo: Up to 5 years
|
Up to 5 years
|
Time to recurrence
Prazo: Up to 5 years
|
Up to 5 years
|
Time to first progression
Prazo: Up to 5 years
|
Up to 5 years
|
Bowel function as measured by the Patient Bowel Function (Uniscale) Questionnaire, the FACT Diarrhea Subscale and the Mayo Bowel Function Questionnaire
Prazo: Up to 5 years
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Frank Sinicrope, MD, Mayo Clinic
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Inibidores da Ciclooxigenase
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Inibidores da Ciclooxigenase 2
- Capecitabina
- Celecoxibe
Outros números de identificação do estudo
- NCCTG-N0346
- NCI-2012-02582 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- CDR0000360666 (Identificador de registro: PDQ (Physician Data Query))
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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