- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00280761
Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy
A Biologic Study of Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
Primary
- Observe whether NF-kappa B is activated in response to treatment with external beam radiotherapy.
- Correlate NF-kappa B pathway activation (presumed to be anti-apoptotic in nature) with therapeutic outcomes (as measured by rate of pathologic complete response or downstaging by endoscopic ultrasound [EUS]).
Secondary
- Study downstream events induced by NF-kappa B activation.
- Determine global gene expression profiles at baseline and during chemoradiotherapy.
- Correlate changes in gene expression (compared with the baseline gene expression pattern) induced by a single dose of external beam radiotherapy with patient outcomes (as measured by pathologic response rate or downstaging by EUS).
- Study downstream events related to activation of p53 in response to treatment with radiotherapy.
- Correlate p53 pathway-mediated events with clinical outcomes.
OUTLINE: Patients receive fluorouracil or capecitabine and undergo radiotherapy and surgery per standard care.
Patients undergo tumor pinch biopsies at baseline and on days 1 and 2 of chemoradiotherapy. At the time of final surgical resection, a portion of the remaining rectal tumor will be liquid nitrogen banked. Patients not deemed surgical candidates are evaluated by transrectal ultrasound 6-8 weeks after completion of chemoradiotherapy to assess ultrasound response (downstaging versus no downstaging).
Tumor tissue samples are analyzed for NF-kappa B pathway activation; downstream events induced by NF-kappa B activation; changes in global gene expression; p53 function; apoptosis; and mRNA expression. Laboratory techniques used include tissue microarray, ELISA, RNase protection assay, fluorescence semi-quantitative PCR, TUNEL, IHC, and cDNA microarray analysis.
If normal tissue from biopsies is not available, whole blood may be collected at any point while patient remains on study for correlative analysis or research related to rectal cancer.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
DISEASE CHARACTERISTICS:
Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample
- Inferior margin of the tumor less than 15 cm from anal verge by rigid sigmoidoscopy or below the level of S1-2 at surgery
Candidate for chemotherapy and radiotherapy, as defined by any of the following:
- Tumor staged as T3 or N1-2 by rectal sonography
- Tumor occupying > 40% of circumference of rectum
- Tumor fixed to extra colonic structures as determined by digital rectal examination
- Tumor < 5 cm from sphincter mechanism
- Patient has inoperable disease and is being treated for palliation
- Pelvic or anastomotic recurrences of previously resected rectal cancer
- Planning to undergo chemotherapy and radiotherapy
- No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection)
PATIENT CHARACTERISTICS:
- Not pregnant
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
1
Single Arm Trial
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Capecitabine administration (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed.
Dosing will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist
Andere Namen:
Administration of 5-fluorouracil (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed.
Dosing and dose modification will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist.
Andere Namen:
Surgery will occur approximately 2-6 weeks after chemoradiation depending on clinical factors (i.e.
resectability, presence or absence of metastatic disease).
Dosing and dose modification will be per current standard of care at the discretion of the treating Radiation Oncologist.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Activation of NF-kappa B in response to treatment with external beam radiotherapy
Zeitfenster: 6-8 weeks after chemoradiation
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6-8 weeks after chemoradiation
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Correlation of NF-kappa B pathway activation with therapeutic outcomes
Zeitfenster: 6-8 weeks after chemoradiation
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6-8 weeks after chemoradiation
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Downstream events induced by NF-kappa B activation
Zeitfenster: 12 months
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12 months
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Global gene expression profiles at baseline and during chemoradiotherapy
Zeitfenster: prior to chemoradiation and 72 days post chemoradiation
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prior to chemoradiation and 72 days post chemoradiation
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Correlation of changes in gene expression with patient outcomes
Zeitfenster: 72 days post chemoradiation
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72 days post chemoradiation
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Downstream events related to activation of p53 in response to treatment with radiotherapy
Zeitfenster: 72 post radiotherapy
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72 post radiotherapy
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Correlation of p53 pathway-mediated events with clinical outcomes
Zeitfenster: 72 days post chemoradiation
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72 days post chemoradiation
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Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Kolorektale Neubildungen
- Rektale Neoplasien
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Fluorouracil
- Capecitabin
Andere Studien-ID-Nummern
- LCCC 0216
- P30CA016086 (US NIH Stipendium/Vertrag)
- CDR0000561688 (Andere Kennung: PDQ number)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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