Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC
NCT ID: NCT01283178
Last Updated: 2016-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2011-07-31
2016-09-30
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer
Detailed Description
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I. To determine the feasibility of integrating molecular imaging (PET with FLT tracer) into current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck cancer.
II. To determine within a predefined range the maximum tolerated radiation dose for concurrent cisplatin and molecular and anatomic image-based IGART of head and neck cancer.
SECONDARY OBJECTIVES I. To compare gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT before, during, and following completion of chemo-radiation therapy.
II. To evaluate the impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake prior to and during radiation therapy using post-treatment FDG images as an early surrogate for sub-volume-specific local control.
III. To develop a database consisting of all molecular and anatomic images, including daily CBCT data sets, obtained during chemo-radiation therapy to support further research. Potential applications include determination of optimal adaptive re-planning frequency and the benefits of basing IGART on 4D anatomic data sets derived from deformably registering daily CBCT and FBCT data sets.
IV. Determine patient long-term toxicities and survival. V. To evaluate the impact of daily image-guided setup; off-line every other week adaptive re-planning; and molecular-image based targeting on sparing of tissues and organs responsible for late and early treatment sequelae.
OUTLINE: This a dose-escalation study of intensity-modulated radiotherapy.
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 and 4 weeks, 2, 3, 4, 5, 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
intensity-modulated radiation therapy
Undergo intensity-modulated image-guided adaptive radiotherapy
cisplatin
Given IV
image-guided adaptive radiation therapy
Undergo intensity-modulated image-guided adaptive radiotherapy
3'-deoxy-3'-[18F]fluorothymidine
Undergo FLT-PET scans for IMRT/IGART
positron emission tomography/computed tomography
Undergo FDG/FLT-PET scans for IMRT/IGARTT
fludeoxyglucose F 18
Undergo FDG-PET scans for IMRT/IGART
Interventions
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intensity-modulated radiation therapy
Undergo intensity-modulated image-guided adaptive radiotherapy
cisplatin
Given IV
image-guided adaptive radiation therapy
Undergo intensity-modulated image-guided adaptive radiotherapy
3'-deoxy-3'-[18F]fluorothymidine
Undergo FLT-PET scans for IMRT/IGART
positron emission tomography/computed tomography
Undergo FDG/FLT-PET scans for IMRT/IGARTT
fludeoxyglucose F 18
Undergo FDG-PET scans for IMRT/IGART
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Locally advanced HN SCC, stages III, IV, and bulky (\> 27 cm\^3 volume) stage II, excluding larynx and nasopharynx, of no more than 150 cm\^3 volume base on CT scan
* All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
* Candidate for chemotherapy
* Zubrod performance score of 0 or 1
* Absolute granulocyte count (AGC) \>= 2000 cells/mm\^3
* Platelet count \>= 100,000 cells/mm\^3
* Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study
* Serum creatinine =\< 1.5 mg/dl or measured or calculated creatinine clearance \>= 50 ml/min
* Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
Exclusion Criteria
* Prior cancer treatment for this cancer, including gross total tumor excision
* Prior radiation treatment to the HN region
* Patients with known syndromes that alter radiosensitivity
* Any medical contraindications for chemotherapy
* Pregnant or lactating women
* Women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter
19 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Shiyu Song
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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NCI-2010-02340
Identifier Type: REGISTRY
Identifier Source: secondary_id
MCC 13222
Identifier Type: -
Identifier Source: org_study_id