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ACTIVE NOT RECRUITING Phase 2

Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

NCT01220583 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Conditions Studied

Interventions

  • DRUG cisplatin
  • RADIATION intensity-modulated radiation therapy
  • RADIATION 3-dimensional conformal radiation therapy

Study Locations (20)

Arizona

  • Arizona Breast Cancer Specialists-Gilbert — Gilbert
  • Arizona Center for Cancer Care-Peoria — Peoria
  • Cancer Center at Saint Joseph's — Phoenix
  • Arizona Breast Cancer Specialists-Phoenix — Phoenix
  • Arizona Oncology-Deer Valley Center — Phoenix
  • Arizona Breast Cancer Specialists — Scottsdale
  • Arizona Breast Cancer Specialists-Scottsdale — Scottsdale
  • Arizona Oncology Services Foundation — Scottsdale
  • Arizona Center for Cancer Care-Surprise — Surprise
  • University of Arizona Cancer Center-Orange Grove Campus — Tucson
  • Banner University Medical Center - Tucson — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

California

  • Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
  • AIS Cancer Center at San Joaquin Community Hospital — Bakersfield
  • Mills-Peninsula Medical Center — Burlingame
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park
  • Mercy San Juan Medical Center — Carmichael
  • City of Hope Comprehensive Cancer Center — Duarte

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham
  • The Kirklin Clinic at Acton Road — Birmingham

Trial Details

FieldValue
Enrollment Target 252 participants
Start Date 2011-01
Est. Completion 2028-10
Phase Phase 2

Sponsor

Radiation Therapy Oncology Group

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01220583

The ClinicalTrials.gov registry entry for NCT01220583 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions — of which cisplatin 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: NCT01220583 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Arizona, California, Alabama. 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 NCT01220583 about?

NCT01220583 is a clinical study titled "Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effe...

What is the current status of trial NCT01220583?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2011-01. Estimated completion is 2028-10.

What conditions does trial NCT01220583 study?

This clinical trial studies the following conditions: Head and Neck Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01220583?

The interventions under investigation include: cisplatin (DRUG), intensity-modulated radiation therapy (RADIATION), 3-dimensional conformal radiation therapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01220583?

This trial is sponsored by Radiation Therapy Oncology Group, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01220583 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. 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