Clinical trial · Interventional
Phase II Trial Evaluating Elimination of Radiation Therapy
Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
NCT00593840CI-TRIAL-00119685active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Larynx | Malignant Laryngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intensity modulated radiation therapy (IMRT)
- 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.
- interventionNames
- Radiation: Intensity modulated radiation therapy
Primary outcomes (1)
- measure
- Number of Participants With a Recurrence in the Unirradiated Neck(s)
- timeFrame
- 12 months of follow-up
- 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.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDChao 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
- BACKGROUNDChao 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
- BACKGROUNDChao 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
- BACKGROUNDChao 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
- BACKGROUNDAng 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
- BACKGROUNDO'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