The Japan clinical oncology group (JCOG) is a cooperative oncology group with the aims of establishing the standard of cancer treatment, mainly in solid cancer. To ensure a quality of clinical trials, quality control (QC) and quality assurance (QA) have been performed in JCOG. Although JCOG consists of thirteen clinical study groups, none of them has conducted clinical trial of head and neck cancer. We are planning to conduct a multicenter phase II trial of chemoradiotherapy (CRT) concurrently with S-1 and cisplatin in patients with unresectable locally advanced head and neck carcinoma as a first JCOG trial of head and neck carcinoma. We hope that this trial give an impulse to increase the number of multicenter clinical trials of head and neck carcinoma in Japan according to understanding of importance of multicenter clinical trials.

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In terms of clinical studies of chemotherapy for patients with head and neck cancer, phase I and II studies on new chemotherapeutic agents and regimen have been done dependently on the pharmaceutical companies associated with the agents. In future constituted groups will design experimental studies on chemotherapy by themselves similarly to the style in the US and Europe and research centers will have to administer the study. In the present paper problems of clinical studies on chemotherapy in cooperative multi-institutes were discussed and recent ongoing-studies were presented.

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The criteria for unresectable head and neck tumors have been unclear so far and are varied between institutions. While 299 patients with hypopharyngeal cancer were enregistered in our institution between 1993 and 2002, unresectable tumors were detected in 16 cases prior to treatment. These cases were investigated retrospectively to know the findings which technical unresectability of tumors based upon. Every lesion was evaluated with X-ray CT or MRI. The most impactive factor on unresectability in cases of hypopharyngeal cancer was carotid artery involvement by cervical metastasis. X-ray CT images or MR images of 9 cases available for this study were reviewed for the degree of involvement by tumors. The images showed 180° to 360° circumferential involvement of the carotid artery in unresectable tumors. Unresectability in the cases of 180° to 240° circumferential involvement depended upon involvement of the carotid bifurcation, skull base involvement or longitudinally wide carotid involvement which were confirmed simultaneously with diagnostic imaging. We believe standing on the report that 270° or less of circumferential involvement can be resectable but the findings described as above should be put in to the criteria. It is necessary to standardize the criteria for unresectability based on imaging studies in order to choose appropriate modalities for cases of head and neck cancers.

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Two hundred and fifty-six patients with oropharyngeal cancer were devided into 196 cases (76%) who received radical therapy and 61 cases (24%) who did not received radical therapy. The subsites of oropharyngeal squamous cell carcinoma in non-radical groups were as followings, anterior wall: 44%, lateral wall: 22%, posterior wall: 21%, superior wall: 9%. The causes of non-radical therapy were classified into 8 groups as followings, 1) poor general condition due to complication: 12. 2) Concomitant double cancer: 7. 3) The patients rejected radical operation: 18. 4) unresectable primary tumors diagnosed at surgery: 8. 5) unresectable neck lymph node metastasis: 5. 6) unresectable primary and neck lymph node metastasis: 4. 7) inoperable due to aging: 4. 8) distant metastasis: 3.

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Patients with head and neck cancers with large neck metastasis (N3) involved carotid artery have very poor outcome often losing important functions such as swallowing and speech despite combined surgery and radiotherapy. Most of such patients die of local recurrence and disseminated metastasis in spite of salvage surgery with carotid resection. Twenty-eight patients with N3 disease were treated by superselective intra-arterial chemotherapy using CDDP and sodium thiosulfate (STS) from 1995 to 2004. Once a week, 100-150mg/m² of CDDP were administered superselectively at 5mg/min through each artery feeding the tumor. During the infusion of CDDP, STS at a dose of two hundred fold that of CDDP was injected through a catheter placed in the subclavian vein. The 5-year overall survival rate was 32% with 100% preservation of the larynx. We could suppress mucositis of normal tissue and chemotoxicities leading to conditions such as renal and hematological dysfunction with CT-angiography. We think this treatment is the best method for N3 disease with involvement of carotid artery.

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Most of the patients with cancer in the oropharynx and the hypopharynx have been diagnosed at advanced stage with symptoms such as dysphagia and discomfort. We revealed that the chronic exposure of the acetaldehyde, the first metabolite of alcohol, was the critical determinant of the “field cancerization” phenomenon, in which multiple cancers in the esophagus and the head and neck region frequently occurred. In addition, we found that narrow band imaging (NBI), the groundbreaking technology in endoscopy, allows us to detect them at an earlier stage. We hope that early detection of the cancer by further effective screening and using magnifying endoscopy coupled with NBI improves the survival of the head and neck cancer patients and also reduce the patients suffering from loss of functions of speaking and swallowing after radical surgery.

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Chemoradiotherapy has been used in an effort to improve therapeutic results for locally advanced head and neck cancer. Improved local-regional control and disease free or overall survival have been shown in several randomized trials using a concurrent or an alternative approach. Induction chemotherapy (neo-adjuvant chemotherapy), however, has not been shown to improve local-regional control or survival. Induction chemotherapy followed by definitive radiotherapy may be useful in the selection patients who are likely to benefit from non-surgical organ preservation treatment schemes. Further clinical trials are needed to clarify the best suitable combination of chemotherapy and radiation. In Japan, the basis of the investigator-initiated clinical trial has not been constructed. So, the necessity of team-based clinical trial was discussed.

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