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PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

3-dimensional conformal radiation therapy

fludeoxyglucose F 18

intensity-modulated radiation therapy

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent adenoid cystic carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent verrucous carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, recurrent basal cell carcinoma of the lip, recurrent squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, untreated metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenocarcinoma, salivary gland adenoid cystic carcinoma, salivary gland anaplastic carcinoma, salivary gland malignant mixed cell type tumor, salivary gland poorly differentiated carcinoma, salivary gland squamous cell carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed head and neck cancer
- No nasopharyngeal or paranasal sinus cancer
- Locally advanced disease (T3 or T4)
- Not in complete remission
Planning to undergo curative radiotherapy (minimum dose of 66 Gy), with or without standard treatment (i.e., platinum-based chemotherapy or biological therapy/rituximab)
Measurable tumor according to RECIST criteria

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Not pregnant or nursing
Able to lie still for 1 hour
No history of progressive neoplastic disease
No known hypersensitivity to fludeoxyglucose F18 or any of its excipients
No severe or uncontrolled systemic disease, including any of the following:
- Kidney disease
- Liver disease
- Cardiac disease
- Unstable or uncompensated respiration
- Uncontrolled diabetes (i.e., glucose ≥ 1.5 g/L)
No geographical, social, or psychological conditions that make follow-up impossible

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior surgery
No concurrent experimental agents

Sites / Locations

Centre Oscar Lambret

Outcomes

Primary Outcome Measures

Difference between the target volume to be irradiated as measured by conventional imagining and PET

Secondary Outcome Measures

Full Information

NCT ID

NCT00809016

First Posted

December 13, 2008

Last Updated

May 12, 2011

Sponsor

Centre Oscar Lambret

1. Study Identification

Unique Protocol Identification Number

NCT00809016

Brief Title

PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

Official Title

Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Centre Oscar Lambret

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. 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. PURPOSE: This clinical trial is studying PET scans to see how well they work in patients with head and neck cancer who are undergoing 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy.

Detailed Description

OBJECTIVES: Primary To assess the value of pre-treatment PET in determining the target volume in patients with head and neck cancer undergoing three-dimensional conformational radiotherapy and intensity-modulated radiotherapy. Secondary To evaluate variations in weekly fludeoxyglucose F 18 PET imaging during the first 5 weeks of treatment. To determine the relationship between changes in tumor metabolism during radiotherapy and control tumor at 3 months and at 1 year post-treatment. OUTLINE: This is a multicenter study. Patients undergo fludeoxyglucose F18 PET (FDG-PET) in addition to conventional imaging at baseline. Patients undergo standard three-dimensional conformational radiotherapy and intensity-modulated radiation therapy 5 days a week for 5 weeks. Some patients also undergo weekly FDG-PET during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent adenoid cystic carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent verrucous carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, recurrent basal cell carcinoma of the lip, recurrent squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, untreated metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenocarcinoma, salivary gland adenoid cystic carcinoma, salivary gland anaplastic carcinoma, salivary gland malignant mixed cell type tumor, salivary gland poorly differentiated carcinoma, salivary gland squamous cell carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Radiation

Intervention Name(s)

3-dimensional conformal radiation therapy

Intervention Type

Radiation

Intervention Name(s)

fludeoxyglucose F 18

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation therapy

Primary Outcome Measure Information:

Title

Difference between the target volume to be irradiated as measured by conventional imagining and PET

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed head and neck cancer No nasopharyngeal or paranasal sinus cancer Locally advanced disease (T3 or T4) Not in complete remission Planning to undergo curative radiotherapy (minimum dose of 66 Gy), with or without standard treatment (i.e., platinum-based chemotherapy or biological therapy/rituximab) Measurable tumor according to RECIST criteria PATIENT CHARACTERISTICS: WHO performance status 0-2 Not pregnant or nursing Able to lie still for 1 hour No history of progressive neoplastic disease No known hypersensitivity to fludeoxyglucose F18 or any of its excipients No severe or uncontrolled systemic disease, including any of the following: Kidney disease Liver disease Cardiac disease Unstable or uncompensated respiration Uncontrolled diabetes (i.e., glucose ≥ 1.5 g/L) No geographical, social, or psychological conditions that make follow-up impossible PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior surgery No concurrent experimental agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Lartigau, MD, PhD

Organizational Affiliation

Centre Oscar Lambret

Facility Information:

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

12. IPD Sharing Statement

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PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

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