Phase II Trial Evaluating Elimination of Radiation Therapy
July 13, 2026 updated by: Washington University School of Medicine
Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer.
In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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St Louis, Missouri, United States, 63110
- Washington University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx .
- Treated with surgical resection with one (or both) side(s) of the neck pathologically N0.
Indication for radiation therapy at the primary site or neck consisting of any of the below characteristics:
- Close margin (<= 0.5 cm)
- Positive margin
- Perineural invasion
- Lymphovascular space invasion
- Metastatic disease in more than one lymph node
- Metastatic disease in more than one lymph node group
- Extracapsular extension in any lymph node
- Constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion.
- Age >= 18.
- Patients must sign study specific, Institutional Review Board (IRB)-approved consent form.
Exclusion Criteria:
- Previous head and neck cancer other than non melanoma skin cancer.
- Previous head and neck surgery.
- Female patients who are pregnant or nursing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensity modulated radiation therapy (IMRT)
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site.
The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions.
The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions.
The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With a Recurrence in the Unirradiated Neck(s)
Time Frame: 12 months of follow-up
|
|
12 months of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kaplan Meier Estimate of Locoregional Recurrence Free Survival
Time Frame: 3 years
|
|
3 years
|
|
Quality of Life (QOL) as Measured by Overall Global QOL Scores
Time Frame: Median follow-up was 22 months
|
-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used.
20 questions with answers of Strongly Agree to Strongly Disagree.
Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
|
Median follow-up was 22 months
|
|
Quality of Life (QOL) as Measured by Xerostomia QOL Data
Time Frame: Median follow-up was 22 months
|
-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used.
20 questions with answers of Strongly Agree to Strongly Disagree.
Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
|
Median follow-up was 22 months
|
|
Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms
Time Frame: Completion of follow-up (minimum of 5 years from completion of treatment)
|
Completion of follow-up (minimum of 5 years from completion of treatment)
|
|
|
Disease Specific Survival Rate
Time Frame: Completion of follow-up (minimum of 5 years from completion of treatment)
|
Completion of follow-up (minimum of 5 years from completion of treatment)
|
|
|
Kaplan Meier Estimate of Overall Survival
Time Frame: 3 years
|
3 years
|
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Patterns of Failure Associated With Implementation of Primary Objective
Time Frame: Completion of follow-up (minimum of 5 years from completion of treatment)
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For patients who demonstrate a local failure during follow-up, a computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imagine (MRI) scan is fused with the original treatment planning CT scan using the computational environment for radiation research (CERR) developed at Washington University Medical Center.
The methodology to transfer the digital imaging study via network to the radiation therapy research servers is mature.
The original dose distribution and contours are correlated with the recurrent disease noted on the follow up imaging study.
The recurrence is then classified as infield, marginal to the treatment field, or out of the treatment field depending on the dose received by the recurrent disease.
Failures that occur in the treatment field are due to aspects of tumor biology rather than errors in the volume irradiated.
As has been the case in our historical controls, the investigators expect most failures to be in the treatment field.
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Completion of follow-up (minimum of 5 years from completion of treatment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wade Thorstad, MD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
- Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
- Chao KS, Low DA, Perez CA, Purdy JA. Intensity-modulated radiation therapy in head and neck cancers: The Mallinckrodt experience. Int J Cancer. 2000 Apr 20;90(2):92-103. doi: 10.1002/(sici)1097-0215(20000420)90:23.0.co;2-9.
- Chao KS, Ozyigit G, Tran BN, Cengiz M, Dempsey JF, Low DA. Patterns of failure in patients receiving definitive and postoperative IMRT for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2003 Feb 1;55(2):312-21. doi: 10.1016/s0360-3016(02)03940-8.
- Chao KS, Majhail N, Huang CJ, Simpson JR, Perez CA, Haughey B, Spector G. Intensity-modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: a comparison with conventional techniques. Radiother Oncol. 2001 Dec;61(3):275-80. doi: 10.1016/s0167-8140(01)00449-2.
- Chao KS, Deasy JO, Markman J, Haynie J, Perez CA, Purdy JA, Low DA. A prospective study of salivary function sparing in patients with head-and-neck cancers receiving intensity-modulated or three-dimensional radiation therapy: initial results. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):907-16. doi: 10.1016/s0360-3016(00)01441-3.
- Ang KK, Trotti A, Brown BW, Garden AS, Foote RL, Morrison WH, Geara FB, Klotch DW, Goepfert H, Peters LJ. Randomized trial addressing risk features and time factors of surgery plus radiotherapy in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):571-8. doi: 10.1016/s0360-3016(01)01690-x.
- Jackson SM, Hay JH, Flores AD, Weir L, Wong FL, Schwindt C, Baerg B. Cancer of the tonsil: the results of ipsilateral radiation treatment. Radiother Oncol. 1999 May;51(2):123-8. doi: 10.1016/s0167-8140(99)00051-1.
- Brazilian Head and Neck Cancer Study Group. End results of a prospective trial on elective lateral neck dissection vs type III modified radical neck dissection in the management of supraglottic and transglottic carcinomas. Head Neck. 1999 Dec;21(8):694-702. doi: 10.1002/(sici)1097-0347(199912)21:83.0.co;2-b.
- Perez CA, Carmichael T, Devineni VR, Simpson JR, Frederickson J, Sessions D, Spector G, Fineberg B. Carcinoma of the tonsillar fossa: a nonrandomized comparison of irradiation alone or combined with surgery: long-term results. Head Neck. 1991 Jul-Aug;13(4):282-90. doi: 10.1002/hed.2880130404.
- O'Sullivan B, Warde P, Grice B, Goh C, Payne D, Liu FF, Waldron J, Bayley A, Irish J, Gullane P, Cummings B. The benefits and pitfalls of ipsilateral radiotherapy in carcinoma of the tonsillar region. Int J Radiat Oncol Biol Phys. 2001 Oct 1;51(2):332-43. doi: 10.1016/s0360-3016(01)01613-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2007
Primary Completion (Actual)
February 28, 2014
Study Completion (Estimated)
April 30, 2027
Study Registration Dates
First Submitted
January 2, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimated)
January 15, 2008
Study Record Updates
Last Update Posted (Actual)
July 29, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Head and Neck Neoplasms
- Respiratory Tract Neoplasms
- Otorhinolaryngologic Diseases
- Otorhinolaryngologic Neoplasms
- Laryngeal Diseases
- Laryngeal Neoplasms
- Therapeutics
- Radiotherapy
- Radiotherapy, Conformal
- Radiotherapy, Computer-Assisted
- Radiotherapy, Intensity-Modulated
Other Study ID Numbers
- 07-0142 / 201106342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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