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- Klinische proef NCT01217060
Trimodality Management of T1b Esophageal Cancers
Phase IIB Study of Trimodality Management of Clinical T1bN0M0 Cancers of the Esophagus
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The Study Treatment:
5-fluorouracil and docetaxel are designed to stop the growth of cancer cells, which may cause the cells to die. Docetaxel may also damage blood vessels in tumor tissue.
The radiation therapy in this study will be either intensity modulated radiation therapy (IMRT), which is a form of photon-based radiation therapy, or proton beam therapy (PBT). This will be up to your doctor. Both IMRT and PBT are designed to give radiation to the tumor area and limiting radiation exposure to nearby organs such as the lungs, heart, and spinal cord.
The surgery in this study removes part of the esophagus and nearby lymph nodes. The type of surgery will be the doctor's decision based on the location of the tumor in the esophagus. It will either be laparoscopic surgery (a minimally invasive procedure through small holes made in the abdomen) or open surgery (through the chest wall).
Study Treatment Administration:
If you are found to be eligible to take part in this study, you will receive radiation therapy and chemotherapy on the following schedule for up to 5 1/2 weeks. If there are holidays on the scheduled treatment days, the schedule may be slightly different and the study staff will discuss this with you.
- Radiation therapy will be given Monday through Friday. This will take about 30 minutes, including about 10-15 minutes for the radiation treatment.
- 5-fluorouracil will be given by vein, continuously for about 96 hours a week (Monday through Friday).
Docetaxel will be given by vein over about 1 hour, 1 time a week (on Mondays).
5-fluorouracil will be given using a portable pump about the size of a personal CD player. You will need to carry this portable pump with you for about 96 hours each week.
Docetaxel will be given through a central venous catheter. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. The catheter will be removed at the end of Week 5.
Before every dose of docetaxel, you will receive dexamethasone to lower the risk of side effects. Dexamethasone will be given by vein over a few seconds.
Your doctor will let you know if and when you are eligible to have surgery. In this study, the surgery must be performed within 8-10 weeks after you finish chemotherapy and radiation therapy. You will be asked to sign a separate consent form that describes the surgery and anesthesia (numbing medicine) and their risks in more detail. The screening tests that will help your doctor decide if you are eligible to have surgery include the scans and endoscopy described below (4-6 weeks after radiation and chemotherapy).
You will no longer be able to receive radiation and chemotherapy if the disease gets worse or intolerable side effects occur. You will not be able to have surgery if the doctor decides surgery is not in your best interest (for example, if the disease or your general health gets worse).
Study Visits:
During Study Therapy:
Blood (about 3 tablespoons) will be drawn for routine tests during Week 3 of radiation and chemotherapy.
Follow-Up:
At 4-6 weeks after your last dose of radiation and chemotherapy, the following tests and procedures will be performed:
- You will have a CT scan of the chest and a whole-body PET/CT scan to check the status of the disease.
- You may have an endoscopy of your esophagus with 1 or more biopsies of the tumor to check the status of the disease. The number of biopsies you have will be the doctor's decision at the time of the procedure, based on the status and location of the disease.
- Blood (about 3 tablespoons) will be drawn for routine tests.
- You will fill out 3 quality-of-life questionnaires. This should take about 10-15 minutes.
About 4 weeks after surgery, you will fill out 3 quality-of-life questionnaires. You will then fill out 2 quality-of-life questionnaires at 6 of your routine follow-up visits after surgery.
Every 3-6 months in the first 3 years after your last dose of radiation and chemotherapy, then every 6 months in the next 2 years, and every year after that from then on, the following tests and procedures will be performed:
- You will have a CT scan of the chest or a whole-body PET/CT scan to check the status of the disease.
- You will have an endoscopy of your esophagus to check the status of the disease during every follow-up visit in Year 1. After that, you will have an endoscopy of your esophagus at follow-up visits anytime the doctor decides it is needed. You will have 1 or more tumor biopsies at these follow-up visits if the doctor decides they are needed, based on the status and location of the disease. This will be decided at the time of the endoscopy.
Biomarker Testing:
If leftover tumor tissue is available from before you joined the study, the leftover tissue will be used for genetic biomarker testing. If you do not have leftover tumor tissue available from before you joined the study, leftover tissue from study procedures will be used for genetic biomarker testing.
This is an investigational study. Docetaxel and 5-fluorouracil are FDA approved and commercially available to treat esophageal cancer. However, it is investigational to give these drugs to patients with early-stage esophageal cancer.
It is investigational to give the combination of chemotherapy, radiation therapy, and surgery to patients with early-stage esophageal cancer.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77030
- University of Texas MD Anderson Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically documented adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction that are staged as T1b using endoscopic ultrasound (EUS) or from a large biopsy (either criteria # 1 or #2 can be met for eligibility).
- Patients who undergo a diagnostic Endoscopic Mucosal Resection (EMR) and have a diagnosis of T1b stage established.
- Performance score Karnofsky Performance Scale (KPS) 80-100.
- Patients should be surgical candidates for esophagectomy and should have no contraindications for chemotherapy or radiation.
- Negative pregnancy test for women of child bearing potential. They must agree to adequate contraception.
- Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, CO2, Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, ALT (SGPT), AST (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) >2,500/uL, platelets > 75,000/uL), renal (creatinine clearance > 50 mL/min), and liver function (bilirubin <=1.5 fold the upper limit of normal and liver enzymes < 3 fold the upper limit of normal).
- Based on the risk factors and propensity of lymph node metastasis (LNM) and poorer survivals seen in retrospective studies as discussed in the introduction, only patients with any one (1) of high risk features such as LVI, tumors >1.2 cm, and high grade will be enrolled (Grade is the pathologic term defining the degree of differentiation. Grade 1 is well differentiated, Grade 2 is moderately differentiated, and Grade 3 is poorly differentiated).
Exclusion Criteria:
- Prior radiation to the chest
- Previous or concomitant cancers other than 1) curatively treated carcinoma in situ of cervix, basal cell of the skin, curative treatment for transitional cell carcinoma of the bladder, and early stage cancers at another non-overlapping site that was treated more than 3 years ago for cure.
- Pregnant or breast-feeding females
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device c) no myocardial infarction within 3 months of registration
- Known hypersensitivity to docetaxel, 5-fluorouracil, polysorbate-80, or any component of the formulation
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Docetaxel + 5-FU + Radiation + Surgery
Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks.
Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel.
5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks.
Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks.
Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
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20 mg/m2 given by vein (IV) over 1 hour once a week for up to 5 1/2 weeks.
Andere namen:
300 mg/m2 given by vein, continuously for 96 hours a week for about 5 1/2 weeks.
Andere namen:
50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks, Monday through Friday.
Andere namen:
Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
Andere namen:
10 mg IV 30 minutes prior to weekly Docetaxel.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pathologic Complete Response (PCR) Rate
Tijdsspanne: Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.
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The primary endpoint for this protocol is to assess the efficacy (pathologic complete response) and safety of Trimodality management (chemoradiotherapy followed by esophagectomy) in patients with clinically staged T1bN0M0 cancer of the esophagus or gastroesophageal junction.
This is a single-arm phase IIB trial of chemo-radiation followed by surgery for patients with early stage grade T1b esophageal cancer.
The rates of pathologic CR will be tabulated and their possible relationships to baseline covariates assessed by logistic regression.
Unadjusted progression free survival time will be estimated by the method of Kaplan and Meier and its possible relationship to baseline covariates assessed by survival regression modeling.
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Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Disease-free Survival (DFS) Time
Tijdsspanne: Time to disease progression or death, up to 6 years
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Disease-free survival (DFS) defined as the time to disease progression or death.
DFS calculated from the time of surgery to disease progression or death.
Followed for disease recurrence every 3-6 months in the first 3 years after last dose of radiation and chemotherapy, then every 6 months in the next 2 years, then every year.
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Time to disease progression or death, up to 6 years
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Steven H. Lin, MD, PHD, M.D. Anderson Cancer Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Hoofd- en nekneoplasmata
- Slokdarmaandoeningen
- Slokdarmneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Ontstekingsremmende middelen
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Anti-emetica
- Gastro-intestinale middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Docetaxel
- Dexamethason
- Fluoruracil
Andere studie-ID-nummers
- 2010-0333
- NCI-2012-01902 (Register-ID: NCI CTRP)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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SanofiVoltooid
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