Clinical trial NCT00593840: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer of the Larynx
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants With a Recurrence in the Unirradiated Neck(s)
timeFrame: 12 months of follow-up
Secondary outcomes:
measure: Kaplan Meier Estimate of Locoregional Recurrence Free Survival
timeFrame: 3 years
measure: Quality of Life (QOL) as Measured by Overall Global QOL Scores
timeFrame: Median follow-up was 22 months
measure: Quality of Life (QOL) as Measured by Xerostomia QOL Data
timeFrame: 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
timeFrame: Completion of follow-up (minimum of 5 years from completion of treatment)
measure: Disease Specific Survival Rate
timeFrame: Completion of follow-up (minimum of 5 years from completion of treatment)
measure: Kaplan Meier Estimate of Overall Survival
timeFrame: 3 years
measure: Patterns of Failure Associated With Implementation of Primary Objective
timeFrame: Completion of follow-up (minimum of 5 years from completion of treatment)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Wade Thorstad, MD
role: PRINCIPAL_INVESTIGATOR
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.