Phase II Trial Evaluating Elimination of Radiation Therapy

NCT00593840 | Active Not Recruiting Phase 2 Results

• 1 other identifier: 07-0142 / 201106342
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer of the Larynx

Outcome Measures

Primary Outcomes (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.

  12 months of follow-up

Secondary Outcomes (7)

• Kaplan Meier Estimate of Locoregional Recurrence Free Survival

  3 years

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

  Median follow-up was 22 months

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

  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

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

• Disease Specific Survival Rate

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

Study Arms (1)

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.

Radiation: Intensity modulated radiation therapy

Interventions

Intensity modulated radiation therapy RADIATION

Also known as: IMRT

Intensity modulated radiation therapy (IMRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Wade Thorstad, M.D.
• Organization: Washington University School of Medicine

thorstad@radonc.wustl.edu

314-362-8516

Study Officials

• Wade Thorstad, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 15, 2008
• Study Start: April 11, 2007
• Primary Completion: February 28, 2014
• Study Completion: April 30, 2026
• Last Updated: May 11, 2025
• Results First Posted: June 2, 2017

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)