Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor - Full Text View

Sponsors and Collaborators:	European Organization for Research and Treatment of Cancer Radiation Therapy Oncology Group National Cancer Institute of Canada Danish Head and Neck Cancer Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00047125

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective in treating patients who have metastases to the lymph nodes in the neck.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have metastases to the lymph nodes in the neck from an unknown primary tumor.

Condition	Intervention	Phase
Carcinoma of Unknown Primary	Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	Randomized Phase III Study On The Selection Of The Target Volume In Postoperative Radiotherapy For Cervical Lymph Node Metastases Of Squamous Cell Carcinoma From And Unknown Primary (CUP)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2002

Detailed Description:

OBJECTIVES:

Compare the disease-free survival of patients with cervical lymph node metastases of squamous cell carcinoma from an unknown primary treated with selective irradiation vs extensive irradiation.
Compare the overall survival of patients treated with these regimens.
Compare the incidence of acute and late side effects in the head and neck region in patients treated with these regimens.
Compare control of the neck and incidence of subsequent primary in the head and neck region in patients treated with these regimens.
Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (N1-2a vs N2b-3), radiation technique (2D vs 3D conformal vs intensity-modulated), and participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo selective irradiation of the ipsilateral level of the neck once daily 5 days a week for 6 weeks.
Arm II: Patients undergo extensive irradiation of the neck (nasopharyngeal, oropharyngeal, hypopharyngeal, and laryngeal mucosa and ipsilateral neck node areas on both sides of the neck) once daily 5 days a week for 6 weeks.

In both arms, treatment continues in the absence of unacceptable toxicity or disease progression.

Quality of life is assessed at baseline, at week 4, on the last day of therapy, and then every 3 months for 1 year.

Patients are followed at day 30, every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 7 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma in cervical lymph node metastasis from an unknown primary tumor
- Histopathological grade WHO 1-3
- Pathological stage N1, N2a, N2b, or N3
- No N2c (i.e., bilateral metastatic nodes)
- No single node in supraclavicular fossa or submandibular area
- No evidence of primary tumor in head and neck, lung, esophageal, or other site
Prior radical, radical modified, or extended radical dissection within the past 8 weeks
- Selective neck dissection allowed (surgeon must justify why standard procedure was not performed)
- No node excision alone
- R0 or R1 disease after dissection
No distant metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Able and willing to complete quality of life questionnaires
No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
No psychological, familial, sociological, or geographical condition that would preclude study compliance
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Concurrent chemotherapy allowed

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

See Disease Characteristics

Other

No other prior therapy for carcinoma of unknown primary except neck dissection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047125

Show 262 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Radiation Therapy Oncology Group

National Cancer Institute of Canada

Danish Head and Neck Cancer Group

Investigators

Investigator:	Vincent G. Gregoire, MD, PhD	Cliniques Universitaires Saint-Luc
Investigator:	Sharon A. Spencer, MD	Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Investigator:	Samy El-Sayed, MD, FFR, FRCR, FRCP	Ottawa Hospital Regional Cancer Centre - General Campus
Investigator:	Esat M. Ozsahin, MD, PhD	Centre Hospitalier Universitaire Vaudois
Investigator:	Cai Grau, MD	Aarhus Universitetshospital - Aarhus Sygehus

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000257596, EORTC-24001, EORTC-22005, DAHANCA-EORTC-24001, CAN-NCIC-EORTC-24001, RTOG-EORTC-24001
Study First Received:	October 3, 2002
Last Updated:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00047125
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

newly diagnosed carcinoma of unknown primary
squamous cell carcinoma of unknown primary

Study placed in the following topic categories:

Epidermoid carcinoma
Neoplasms, Unknown Primary
Squamous cell carcinoma
Carcinoma, squamous cell
Neoplasm Metastasis

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009