Trial record 19 of 25 for:    United States, Indiana | Community Regional Cancer Care

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

This study has been completed.
Sponsor:
Collaborators:
Radiation Therapy Oncology Group
NCIC Clinical Trials Group
Danish Head and Neck Cancer Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00047125
First received: October 3, 2002
Last updated: June 19, 2012
Last verified: June 2012
  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
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • disease-free survival

Enrollment: 600
Study Start Date: July 2002
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selective irradiation
Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).
Radiation: radiation therapy
Active Comparator: Extensive irradiation + ipsilaterals levels
Irradiation on the whole mucosa of the larynx, hypopharynx, oropharynx and nasopharynx, and on both sides of the neck (levels I -V) up to a prophylactic dose of 50 Gy (25 x 2 Gy in 5 week).Irradiation of the ipsilateral level I - V of the neck should continue with an additional 10 Gy boost for a total dose of 60 Gy (30 x 2 Gy in 6 weeks).
Radiation: radiation therapy

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 Organisation for Research and Treatment of Cancer - EORTC
Radiation Therapy Oncology Group
NCIC Clinical Trials Group
Danish Head and Neck Cancer Group
Investigators
Study Chair: Vincent G. Gregoire, MD, PhD Cliniques universitaires Saint-Luc
Study Chair: Sharon A. Spencer, MD University of Alabama at Birmingham
Study Chair: Samy El-Sayed, MD, FFR, FRCR, FRCP Ottawa Regional Cancer Centre
Study Chair: Esat M. Ozsahin, MD, PhD Centre Hospitalier Universitaire Vaudois
Study Chair: Cai Grau, MD Aarhus Universitetshospital - Aarhus Sygehus
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00047125     History of Changes
Other Study ID Numbers: EORTC-24001-22005, EORTC-24001, EORTC-22005, DAHANCA-EORTC-24001, CAN-NCIC-EORTC-24001, RTOG-EORTC-24001
Study First Received: October 3, 2002
Last Updated: June 19, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
newly diagnosed carcinoma of unknown primary
squamous cell carcinoma of unknown primary

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasm Metastasis
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014