NCT00593840 · REGISTRY CONDITION SEARCH

Phase II Trial Evaluating Elimination of Radiation Therapy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-07-29

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

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.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Kaplan Meier Estimate of Locoregional Recurrence Free Survival

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · NOT POSTED

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

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outcome · NOT POSTED

Disease Specific Survival Rate

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outcome · POSTED

Kaplan Meier Estimate of Overall Survival

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outcome · NOT POSTED

Patterns of Failure Associated With Implementation of Primary Objective

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outcome · POSTED

Kaplan Meier Estimate of Regional Recurrence Free Survival

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outcome · POSTED

Kaplan Meier Estimate of Progression-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
-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.
intervention Names
Radiation: Intensity modulated radiation therapy
label
Intensity modulated radiation therapy (IMRT)
type
EXPERIMENTAL

interventions

arm Group Labels
Intensity modulated radiation therapy (IMRT)
name
Intensity modulated radiation therapy
other Names
IMRT
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 74
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
* 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.
measure
Number of Participants With a Recurrence in the Unirradiated Neck(s)
time Frame
12 months of follow-up

secondary Outcomes

description
* 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
measure
Kaplan Meier Estimate of Locoregional Recurrence Free Survival
time Frame
3 years
description
-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.
measure
Quality of Life (QOL) as Measured by Overall Global QOL Scores
time Frame
Median follow-up was 22 months
description
-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.
measure
Quality of Life (QOL) as Measured by Xerostomia QOL Data
time Frame
Median follow-up was 22 months
measure
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)
measure
Disease Specific Survival Rate
time Frame
Completion of follow-up (minimum of 5 years from completion of treatment)
measure
Kaplan Meier Estimate of Overall Survival
time Frame
3 years
description
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.
measure
Patterns of Failure Associated With Implementation of Primary Objective
time Frame
Completion of follow-up (minimum of 5 years from completion of treatment)

Full study description

brief 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. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue

Source references

references

citation
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.
pmid
10814959
type
BACKGROUND
citation
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.
pmid
12527043
type
BACKGROUND
citation
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.
pmid
11730997
type
BACKGROUND
citation
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.
pmid
11240231
type
BACKGROUND
citation
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.
pmid
11597795
type
BACKGROUND
citation
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.
pmid
11567806
type
BACKGROUND
citation
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.
pmid
10435802
type
BACKGROUND
citation
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.
pmid
10562681
type
BACKGROUND
citation
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.
pmid
15128893
type
BACKGROUND
citation
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.
pmid
15128894
type
BACKGROUND
citation
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.
pmid
1907952
type
BACKGROUND