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Head and Neck CancerPhase 1/2NCT00006360

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

A Phase 1/2 study testing radioprotection and radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Radiation Therapy Oncology Group at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Head and Neck Cancer, Radiation Toxicity
What is being tested?
radioprotection and radiation therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
18 sitesin 2 countries
Study dates
Feb 2001to Dec 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States15 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0010

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0385

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • All Saints Cancer Center at All Saints Healthcare

    Racine, Wisconsin, 53405

  • Community Cancer Center at Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Community Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

Other trials in United States

Canada3 sites

  • Stollery Children's Hospital at University of Alberta Hospital

    Edmonton, Alberta, T6G 2R7

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4MI

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

Other trials in Canada

About this study

Official title: Conformal and Intensity Modulated Irradiation for 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.

Read the 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.

Being tested
radioprotection, radiation therapy
Keywords
stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, radiation toxicity
Medical subject headings
Head and Neck Neoplasms, Radiation Injuries, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radioprotectionDrug

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionNov 2005
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006360
Sponsor's protocol ID
RTOG-0022
Other IDs
CDR0000068231, RTOG-H-0022
Status last verified
Dec 2016
First submitted
4 Oct 2000
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17576443

  • 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.

    PubMed 19540060

  • 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.

  • 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.

    PubMed 36925074

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing radioprotection and radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Radiation Therapy Oncology Group at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute salivary gland toxicity. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006360, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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