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NCT00006360 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2020-10-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    radioprotection
    type
    DRUG
  2. name
    radiation therapy
    type
    RADIATION
Study design
primary Purpose
TREATMENT
EnrollmentSource null
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Acute salivary gland toxicity
  2. measure
    Locoregional control
  3. measure
    Whole mouth saliva output relative to pre-radiotherapy measurements
  4. measure
    Acute mucositis and other acute and late toxicities
Full study description
brief Summary
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.
detailed Description
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.
Source references
references
  1. citation
    Ploquin N, Lau H, Dunscombe P. Intensity modulated and three-dimensional conformal radiation therapy plans for oropharyngeal cancer: a comparison of their sensitivity to set-up errors and uncertainties. Curr Oncol. 2006 Apr;13(2):61-6. doi: 10.3390/curroncol13020005.
    pmid
    17576443
    type
    BACKGROUND
  2. citation
    Eisbruch A, Harris J, Garden AS, Chao CK, Straube W, Harari PM, Sanguineti G, Jones CU, Bosch WR, Ang KK. Multi-institutional trial of accelerated hypofractionated intensity-modulated radiation therapy for early-stage oropharyngeal cancer (RTOG 00-22). Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1333-8. doi: 10.1016/j.ijrobp.2009.04.011. Epub 2009 Jun 18.
    pmid
    19540060
    type
    RESULT
  3. citation
    Eisbruch A, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT for oropharyngeal cancer (RTOG 00-22): early results. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-79, S46-7, 2006.
    type
    RESULT
  4. citation
    Garden AS, Harris J, Eisbruch A, Chao KSC, Morrison WH, Harari PM, Swanson TA, Jones CU, Yom SS, Spencer SA, Scrimger R, Shenouda G, Shukla M, Lau HY, Mierzwa M, Torres-Saavedra P, Le QT. Final Report of NRG Oncology RTOG 0022: A Phase 1/2 Study of Conformal and Intensity Modulated Radiation for Oropharyngeal Cancer. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):333-340. doi: 10.1016/j.ijrobp.2023.02.057. Epub 2023 Mar 15. No abstract available.
    pmid
    36925074
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        idence (definitive radiation therapy):</p> <div class="pdq-content-list"><ol id="_590"><li>IMRT was studied in a phase II trial (<a href="/clinicaltrials/NCT00006360">RTOG-0022</a> [NCT00006360]) of 69 patients with stages T1 to T2, N0 to N1, M0 oropharyngeal carcinoma who were treated with primary radiation therapy without
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      2. context exact
        therapy):</p> <div class="pdq-content-list"><ol id="_590"><li>IMRT was studied in a phase II trial (<a href="/clinicaltrials/NCT00006360">RTOG-0022</a> [NCT00006360]) of 69 patients with stages T1 to T2, N0 to N1, M0 oropharyngeal carcinoma who were treated with primary radiation therapy without chemotherapy.[<a href="#cit
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      3. context exact
        nths but was reduced to 25% of patients at 12 months and 16% of patients at 24 months. </li></ul></div><p id="_592" tabindex="-1">The <a href="/clinicaltrials/NCT00006360">RTOG-0022</a> study showed high control rates and the feasibility of IMRT at a multi-institutional level; the study also showed high tumor control rates and
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      source title
      Oropharyngeal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice