Phase II Trial Evaluating Elimination of Radiation Therapy - Full Text View

Purpose

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, we plan to reduce the amount of radiation treatment received to healthy tissue

Condition	Intervention	Phase
Cancer of the Larynx	Radiation: IMRT	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Eliminate radiation of PN0 neck(s) and demonstrate >90% control in the unirradiated neck(s) [ Time Frame: 12 months of follow-up ] [ Designated as safety issue: No ]
Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.

Secondary Outcome Measures:

Evaluate the rates of locoregional control, disease specific survival, overall survival, and patterns of failure [ Time Frame: 5 years from completion of treatment ] [ Designated as safety issue: No ]
Evaluate impact of treatment volume on toxicity and quality of life through the use of validated PRO QOL instruments with PTV as a continuous variable. [ Time Frame: Acute toxicity = through 90 days after completion of treatment, Late = from 90 days through patient's death ] [ Designated as safety issue: Yes ]
Compare standard treatment volume (CTV and PTV) with protocol defined treatment volume in terms of organ specific dose volume histograms [ Time Frame: Completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	69
Study Start Date:	April 2007
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IMRT CTV1 = 66 Gy in 33 fractions CTV2 = 60 Gy in 33 fractions CTV3 = 56 Gy in 33 fractions CTV3 Proto = 56 Gy in 33 fractions	Radiation: IMRT

Detailed Description:

The proposed study will prospectively test whether this method of volume reduction can be implemented without a change in the historical institutional locoregional control rate achieved with intensity modulated postoperative radiation therapy (IMPORT). Quality of life measurements via validated instruments will be incorporated to establish correlation of volume reduction with QOL.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593840

Contacts

Contact: Wade Thorstad, MD

(314) 362-8516

thorstad@radonc.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Wade Thorstad, M.D. 314-362-8516 thorstad@radonc.wustl.edu
Principal Investigator: Wade Thorstad, M.D.
Sub-Investigator: Bruce Haughey, M.B, Ch.B.
Sub-Investigator: Douglas Adkins, M.D.
Sub-Investigator: Brian Nussenbaum, M.D.
Sub-Investigator: Joseph Deasy, Ph.D.

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Wade Thorstad, MD

Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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.

Chao, K.S., et al., Patterns of failure in patients receiving definitive and postoperative IMRT for head-and-neck cancer. Int J Radiat Oncol Biol Phys, 2003. 55(2): p. 312-21.

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.

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.

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.

O'Sullivan, B., et al., The benefits and pitfalls of ipsilateral radiotherapy in carcinoma of the tonsillar region. Int J Radiat Oncol Biol Phys, 2001. 51(2): p. 332-43.

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.

[No authors listed] 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. Brazilian Head and Neck Cancer Study Group. Head Neck. 1999 Dec;21(8):694-702.

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.

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.

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.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00593840 History of Changes
Other Study ID Numbers:	07-0142 / 201106342
Study First Received:	January 2, 2008
Last Updated:	May 22, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013