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Cancer of the LarynxPhase 2NCT00593840

Phase II Trial Evaluating Elimination of Radiation Therapy

A Phase 2 study testing Intensity modulated radiation therapy in people with Cancer of the Larynx, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of the Larynx
What is being tested?
Intensity modulated radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
11 Apr 2007to 30 Apr 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • Previous head and neck cancer other than non melanoma skin cancer.
  • Previous head and neck surgery.
  • Female patients who are pregnant or nursing.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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

Being tested
Intensity modulated radiation therapy
Medical subject headings
Laryngeal Neoplasms

What participants receive

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

  • Intensity modulated radiation therapyRadiation

    Also called IMRT

Study groups in NCT00593840
Study groupRoleWhat they receive
Intensity modulated radiation therapy (IMRT)Experimental-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.
Receives: Radiation: Intensity modulated radiation therapy

What is being measured

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

  1. Number of Participants With a Recurrence in the Unirradiated Neck(s)

    • Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.
    • Recurrence is defined as the return of cancer after treatment
    • Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.

    Measured: 12 months of follow-up

Secondary outcomes (7)

  1. Kaplan Meier Estimate of Locoregional Recurrence Free Survival

    • Recurrence is defined as the return of cancer after treatment
    • Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame

    Measured: 3 years

  2. Quality of Life (QOL) as Measured by Overall Global QOL Scores

    -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.

    Measured: Median follow-up was 22 months

  3. Quality of Life (QOL) as Measured by Xerostomia QOL Data

    -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.

    Measured: Median follow-up was 22 months

  4. Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms

    Measured: Completion of follow-up (minimum of 5 years from completion of treatment)

  5. Disease Specific Survival Rate

    Measured: Completion of follow-up (minimum of 5 years from completion of treatment)

  6. Kaplan Meier Estimate of Overall Survival

    Measured: 3 years

  7. Patterns of Failure Associated With Implementation of Primary Objective

    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.

    Measured: Completion of follow-up (minimum of 5 years from completion of treatment)

Timeline

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

  1. First posted15 Jan 2008 (estimated)
  2. Study start11 Apr 2007
  3. Primary completion28 Feb 2014
  4. Study completion30 Apr 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00593840
Sponsor's protocol ID
07-0142 / 201106342
Status last verified
Jul 2026
First submitted
2 Jan 2008
Last updated
29 Jul 2026
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10814959

  • 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.

    PubMed 12527043

  • 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.

    PubMed 11730997

  • 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.

    PubMed 11240231

  • 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.

    PubMed 11597795

  • 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.

    PubMed 11567806

  • 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.

    PubMed 10435802

  • 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.

    PubMed 10562681

  • 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.

    PubMed 15128893

  • 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.

    PubMed 15128894

  • 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.

    PubMed 1907952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intensity modulated radiation therapy in people with Cancer of the Larynx, run by Washington University School of Medicine at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 13 inclusion and 3 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 2 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With a Recurrence in the Unirradiated Neck(s) (time frame: 12 months of follow-up). 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 NCT00593840, which also lists 11 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 29 Jul 2026.

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