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

October 27, 2016 updated by: Virginia Commonwealth University

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: cisplatin
Given IV
Other Names:
  • CDDP
  • DDP
  • CACP
  • CPDD
Radiation: intensity-modulated radiation therapy
Undergo intensity-modulated image-guided adaptive radiotherapy
Other Names:
  • IMRT
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Before, during, and following completion of chemoradiation therapy
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
Prior to and during radiation therapy
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
Up to 5 years
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Shiyu Song, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 24, 2011

First Posted (ESTIMATE)

January 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC 13222
  • P30CA016059 (U.S. NIH Grant/Contract)
  • NCI-2010-02340 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data analysis was futile with only 3 accruals. PI opted to terminate with the IRB and withdraw the FDA IND.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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