NCT00809016

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

July 1, 2009

Enrollment Period

4 years

First QC Date

December 13, 2008

Last Update Submit

May 12, 2011

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavityrecurrent basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavitystage III basal cell carcinoma of the lipstage III squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV squamous cell carcinoma of the lip and oral cavitymetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primaryrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxhigh-grade salivary gland mucoepidermoid carcinomalow-grade salivary gland mucoepidermoid carcinomarecurrent salivary gland cancersalivary gland acinic cell tumorsalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland anaplastic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomastage III salivary gland cancerstage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

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

Interventions

3-dimensional conformal radiation therapyRADIATION
fludeoxyglucose F 18RADIATION
intensity-modulated radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Interventions

Radiotherapy, ConformalFluorodeoxyglucose F18Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeuticsDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Eric Lartigau, MD, PhD

    Centre Oscar Lambret

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2008

First Posted

December 16, 2008

Study Start

May 1, 2007

Primary Completion

May 1, 2011

Last Updated

May 13, 2011

Record last verified: 2009-07

Locations

FR(1)