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COMPLETED Phase 1

Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer

NCT00761345 · View on ClinicalTrials.gov ↗

Study Summary

People with pancreatic cancer usually have a large amount of the cancer in the area of the pancreas and around it when they are diagnosed with it. Or their cancer has spread (metastasized)outside that area of the abdomen and is not able to be surgically removed (resected). For patients with metastatic disease, one standard treatment is the combination of gemcitabine and erlotinib. This combination has shown slightly longer survival compared to getting gemcitabine alone. For patients with localized but unresectable disease, the standard treatment remains controversial. Early studies showed that chemotherapy and radiation together was better than either one used alone. The greatest benefit of external beam radiotherapy may be after a period of full-dose chemotherapy alone, to help the rapid spread. A problem of beginning treatment with standard radiotherapy is that the doses of chemotherapy usually have to be reduced sometimes by half. Studies have already shown that low dose radiotherapy (LDRT)is safe. This study will evaluate the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer. Patients will be enrolled in groups of 3 to 6 each with a slightly higher dose of LDRT and erlotinib. For patients with locally advanced disease, this protocol also may help because most patients develop and die from spread to the liver and abdominal cavity.

Interventions

  • DRUG gemcitabine
  • DRUG Erlotinib
  • RADIATION low dose fractionated radiotherapy

Study Locations (3)

Pennsylvania

  • Fox Chase Cancer Center — Philadelphia
  • Reading Medical Center — West Reading

Michigan

  • Karmanos Cancer Institue — Detroit

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2008-09
Est. Completion 2015-02
Phase Phase 1

Sponsor

Fox Chase Cancer Center

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00761345

The ClinicalTrials.gov registry entry for NCT00761345 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fox Chase Cancer Center, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Metastatic Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions — of which gemcitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00761345 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00761345 about?

NCT00761345 is a clinical study titled "Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer". People with pancreatic cancer usually have a large amount of the cancer in the area of the pancreas and around it when they are diagnosed with it. Or their cancer has spread (metastasized)outside that area of the abdomen and is not able to be surgically removed (resected). For patients with metastat...

What is the current status of trial NCT00761345?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2008-09. Estimated completion is 2015-02.

What conditions does trial NCT00761345 study?

This clinical trial studies the following conditions: Metastatic Pancreatic Cancer, Pancreatic Carcinoma Non-resectable. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00761345?

The interventions under investigation include: gemcitabine (DRUG), Erlotinib (DRUG), low dose fractionated radiotherapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00761345?

This trial is sponsored by Fox Chase Cancer Center, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00761345 being conducted?

This trial has 3 study locations across Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial