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Completed

NCT Number: NCT00006360

Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Radiation Injuries Radiation Toxicity Squamous Cell Carcinoma of Head and Neck Wounds and Injuries

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stollery Children's Hospital at University of Alberta Hospital, Edmonton, Alberta, Canada

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About this study

OBJECTIVES:

  • Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy.
  • Determine the nature and prevalence of acute and late side effects of this treatment in these patients.
  • Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment.

OUTLINE: This is a multicenter study.

Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands.

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

PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate)
  • Lymph nodes in both sides of neck at risk of metastatic disease and require radiotherapy
  • Patients upstaged by imaging to N2 are eligible
  • Measurable or evaluable disease
  • Greater than 1 cm in one dimension or with necrotic regions if by CT or MRI scan
  • Surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No active untreated infection
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or a carcinoma not of head or neck origin
  • No concurrent major medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • More than 3 months since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior head or neck radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent treatment for head and neck cancer
  • No prophylactic amifostine or pilocarpine

Treatment and study plan

radioprotection

Drug

radiation therapy

Radiation

Primary outcomes

  1. Acute salivary gland toxicity

  2. Locoregional control

  3. Whole mouth saliva output relative to pre-radiotherapy measurements

  4. Acute mucositis and other acute and late toxicities

Sponsors and collaborators

Lead sponsor

Radiation Therapy Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

Important dates

Study start
2001
Primary completion
2005
Study completion
2016
First posted
Jan 27, 2003
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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