Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01283178
First received: January 24, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. 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. Giving radiation therapy together with cisplatin may kill more tumor cells.

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


Condition Intervention Phase
Salivary Gland Squamous Cell Carcinoma
Stage II Salivary Gland Cancer
Stage II Squamous Cell Carcinoma of the Hypopharynx
Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage II Squamous Cell Carcinoma of the Oropharynx
Stage II Verrucous Carcinoma of the Oral Cavity
Stage III Salivary Gland Cancer
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Salivary Gland Cancer
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Verrucous Carcinoma of the Oral Cavity
Radiation: intensity-modulated radiation therapy
Drug: cisplatin
Radiation: image-guided adaptive radiation therapy
Other: 3'-deoxy-3'-[18F]fluorothymidine
Procedure: positron emission tomography/computed tomography
Radiation: fludeoxyglucose F 18
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Trial: Concurrent Intensity-Modulated Radiotherapy (IMRT) and Chemotherapy With Molecular Image-Guided Adaptive Radiation Therapy (IGART) for Advanced Head and Neck Squamous Cell Carcinomas (HNSCC)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT [ Time Frame: Before, during, and following completion of chemoradiation therapy ] [ Designated as safety issue: No ]
  • Impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake using post-treatment FDG images as an early surrogate for sub-volume-specific local control [ Time Frame: Prior to and during radiation therapy ] [ Designated as safety issue: No ]
  • Development of a database consisting of all molecular and anatomic images, including daily CBCT data sets, obtained during chemo-radiation therapy to support further research [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Patient long-term toxicities and survival [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Radiation: intensity-modulated radiation therapy
Undergo intensity-modulated image-guided adaptive radiotherapy
Other Name: IMRT
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Radiation: image-guided adaptive radiation therapy
Undergo intensity-modulated image-guided adaptive radiotherapy
Other Names:
  • IGART
  • image-guided adaptive radiotherapy
Other: 3'-deoxy-3'-[18F]fluorothymidine
Undergo FLT-PET scans for IMRT/IGART
Other Name: 18F-FLT
Procedure: positron emission tomography/computed tomography
Undergo FDG/FLT-PET scans for IMRT/IGARTT
Radiation: fludeoxyglucose F 18
Undergo FDG-PET scans for IMRT/IGART
Other Names:
  • 18FDG
  • FDG

Detailed Description:

PRIMARY OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease
  • 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 invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283178

Contacts
Contact: Shiyu Song, MD, PhD 804-828-7232 ssong@mcvh-vcu.edu
Contact: Diane J. Holdford, RN 804-828-0296 djholdfo@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Shiyu Song, MD, PhD    804-628-1939    ssong@vcu.edu   
Contact: Diane J. Holdford, RN    804-828-0296    djholdfo@vcu.edu   
Principal Investigator: Shiyu Song         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Shiyu Song Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01283178     History of Changes
Other Study ID Numbers: MCC 13222, NCI-2010-02340, P30CA016059
Study First Received: January 24, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:
squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Salivary Gland Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cisplatin
Fluorodeoxyglucose F18
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014