Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Treatment has been primarily surgery, which is usually followed with postoperative radiation therapy. Because these tumors are clinically silent until they reach advanced stages, it is very unusual to diagnose these tumors at the T2 N0 stage.

Standard treatment options:

1. Laryngopharyngectomy and neck dissection has been the most frequently used therapy for hypopharyngeal cancers. In very selected cases of pyriform sinus cancers, that is, those arising in the upper medial wall, a partial laryngopharyngectomy may be successfully used to preserve vocal function. In T2 cases, postoperative radiation therapy has been given in combination with surgery in an effort to improve the local control rates of surgery alone. There are advocates of preoperative radiation therapy, but all groups giving radiation advocate high-dose treatment to the primary site and to both sides of the neck to include the retropharyngeal and lateral cervical nodes.[1,2]



2. Neoadjuvant chemotherapy, as given in clinical trials, has been used to shrink tumors and render them more definitively treatable with either surgery or radiation. The chemotherapy is given prior to the other modalities, hence the designation, neoadjuvant, to distinguish it from standard adjuvant therapy, which is given after or during definitive therapy with radiation or after surgery. Many drug combinations have been used in neoadjuvant chemotherapy. Neoadjuvant chemotherapy is commonly used to treat patients who present with advanced disease to improve locoregional control or survival, despite the lack of data from randomized, prospective trials.[3] The use of neoadjuvant chemotherapy to increase organ preservation has also been advocated. In a prospective randomized trial (NCT-00169247), the European Organization for the Research and Treatment of Cancer compared surgery plus postoperative radiation therapy to neoadjuvant chemotherapy (i.e., cisplatin plus 5-fluorouracil) followed by radiation in responding patients. Local and regional failures were similar in both groups. Although median survival was 25 months in the immediate surgery arm of the study and 44 months in the induction chemotherapy arm (P = .006), 5-year disease-free and overall survival were the same. A functional larynx was preserved in 42% of patients at 3 years and 35% at 5 years in patients who received induction chemotherapy. These data have not been confirmed by other phase III trials but suggest that larynx preservation may be feasible without jeopardizing survival.[4][Level of evidence: 1iiA,1iiC]

   Most neoadjuvant chemotherapy clinical trials have included stage II hypopharyngeal carcinoma patients for the trials because of the low survival rates for this group of patients.[5]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage II hypopharyngeal cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Mendenhall WM, Parsons JT, Devine JW, et al.: Squamous cell carcinoma of the pyriform sinus treated with surgery and/or radiotherapy. Head Neck Surg 10 (2): 88-92, 1987 Nov-Dec.  [PUBMED Abstract]
   
   
2. Murthy AK, Galinsky D, Hendrickson FR: Hypopharynx. In: Laramore GE, ed.: Radiation Therapy of Head and Neck Cancer. Berlin: Springer-Verlag, 1989, pp 107-24. 
   
   
3. Harari PM: Why has induction chemotherapy for advanced head and neck cancer become a United States community standard of practice? J Clin Oncol 15 (5): 2050-5, 1997.  [PUBMED Abstract]
   
   
4. Lefebvre JL, Chevalier D, Luboinski B, et al.: Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group. J Natl Cancer Inst 88 (13): 890-9, 1996.  [PUBMED Abstract]
   
   
5. Meoz-Mendez RT, Fletcher GH, Guillamondegui OM, et al.: Analysis of the results of irradiation in the treatment of squamous cell carcinomas of the pharyngeal walls. Int J Radiat Oncol Biol Phys 4 (7-8): 579-85, 1978 Jul-Aug.  [PUBMED Abstract]
   
   

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