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Phase II Trial Evaluating Elimination of Radiation Therapy

Primary Purpose

Cancer of the Larynx

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensity modulated radiation therapy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Larynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensity modulated radiation therapy (IMRT)

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms
Disease Specific Survival Rate
Kaplan Meier Estimate of Overall Survival
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.

Full Information

First Posted
January 2, 2008
Last Updated
July 14, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00593840
Brief Title
Phase II Trial Evaluating Elimination of Radiation Therapy
Official Title
Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 11, 2007 (Actual)
Primary Completion Date
February 28, 2014 (Actual)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Larynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensity modulated radiation therapy (IMRT)
Arm Type
Experimental
Arm 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 Type
Radiation
Intervention Name(s)
Intensity modulated radiation therapy
Other Intervention Name(s)
IMRT
Primary Outcome Measure Information:
Title
Number of Participants With a Recurrence in the Unirradiated Neck(s)
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.
Time Frame
12 months of follow-up
Secondary Outcome Measure Information:
Title
Kaplan Meier Estimate of Locoregional Recurrence Free Survival
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
Time Frame
3 years
Title
Quality of Life (QOL) as Measured by Overall Global QOL Scores
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.
Time Frame
Median follow-up was 22 months
Title
Quality of Life (QOL) as Measured by Xerostomia QOL Data
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.
Time Frame
Median follow-up was 22 months
Title
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)
Title
Disease Specific Survival Rate
Time Frame
Completion of follow-up (minimum of 5 years from completion of treatment)
Title
Kaplan Meier Estimate of Overall Survival
Time Frame
3 years
Title
Patterns of Failure Associated With Implementation of Primary Objective
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.
Time Frame
Completion of follow-up (minimum of 5 years from completion of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wade Thorstad, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10814959
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.
Results Reference
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PubMed Identifier
12527043
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.
Results Reference
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PubMed Identifier
11730997
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.
Results Reference
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PubMed Identifier
11240231
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.
Results Reference
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PubMed Identifier
11597795
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.
Results Reference
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PubMed Identifier
11567806
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. Erratum In: Int J Radiat Oncol Biol Phys 2001 Dec 1;51(5):1465.
Results Reference
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PubMed Identifier
10435802
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.
Results Reference
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PubMed Identifier
10562681
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.
Results Reference
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PubMed Identifier
15128893
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Phase II Trial Evaluating Elimination of Radiation Therapy

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