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Salivary Gland Squamous Cell CarcinomaPhase 1NCT01283178

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

A Phase 1 study testing intensity-modulated radiation therapy, cisplatin and image-guided adaptive radiation therapy in people with Salivary Gland Squamous Cell Carcinoma and Stage II Salivary Gland Cancer, run by Virginia Commonwealth University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
intensity-modulated radiation therapy, cisplatin and image-guided adaptive radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Jul 2011to Sep 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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)

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
intensity-modulated radiation therapy, cisplatin, image-guided adaptive radiation therapy, 3'-deoxy-3'-[18F]fluorothymidine, positron emission tomography/computed tomography
Keywords
squamous cell carcinoma of the paranasal sinus and nasal cavity
Medical subject headings
Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intensity-modulated radiation therapyRadiation

    Also called IMRT

    Undergo intensity-modulated image-guided adaptive radiotherapy

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • image-guided adaptive radiation therapyRadiation

    Also called IGART, image-guided adaptive radiotherapy

    Undergo intensity-modulated image-guided adaptive radiotherapy

  • 3'-deoxy-3'-[18F]fluorothymidineOther

    Also called 18F-FLT

    Undergo FLT-PET scans for IMRT/IGART

  • positron emission tomography/computed tomographyProcedure or surgery

    Undergo FDG/FLT-PET scans for IMRT/IGARTT

  • fludeoxyglucose F 18Radiation

    Also called 18FDG, FDG

    Undergo FDG-PET scans for IMRT/IGART

Study groups in NCT01283178
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 weeks

Secondary outcomes (5)

  1. Comparison of gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT

    Measured: Before, during, and following completion of chemoradiation therapy

  2. 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

    Measured: Prior to and during radiation therapy

  3. 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

    Measured: Up to 5 years

  4. Patient long-term toxicities and survival

    Measured: 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

  5. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionMar 2016
  4. Study completionSep 2016

Why it stopped: The study was terminated. The data analysis was futile with only 3 accruals. PI opted to terminate with IRB and withdraw FDA IND.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283178
Sponsor's protocol ID
MCC 13222
Other IDs
NCI-2010-02340, P30CA016059
Status last verified
Oct 2016
First submitted
24 Jan 2011
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: The data analysis was futile with only 3 accruals. PI opted to terminate with the IRB and withdraw the FDA IND.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing intensity-modulated radiation therapy, cisplatin and image-guided adaptive radiation therapy in people with Salivary Gland Squamous Cell Carcinoma and Stage II Salivary Gland Cancer, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated. The data analysis was futile with only 3 accruals. PI opted to terminate with IRB and withdraw FDA IND.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01283178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.

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