Head and Neck Tumors

Clinical trial with carbon ion radiotherapy for the head and neck tumors was conducted under the Phase I/II Clinical Trial (Protocol 9301) on Heavy Particle Radiotherapy for Malignant Head and Neck Tumors, that was initiated in June 1994 by way of a dose escalation study on a fractionation method of 18 fractions over 6 weeks. This trial was followed by a next dose fractionation and dose escalation study commenced in June 1996 under the Phase I/II Clinical Trial (Protocol 9504) on Heavy Particle Radiotherapy for Malignant Head and Neck Tumors using a fractionation method of 16 fractions over 4 weeks. The results of these two trials were published in 1994 [1]. Following the outcome of these two studies, the Phase II Clinical Trial on Heavy Particle Radiotherapy for Malignant Head and Neck Tumors (Protocol 9602) was initiated on a 64.0GyE/16 fractions/4 weeks fractionation method (or 57.6 GyE/16 fractions/4 weeks when the wide-range of the skin was included in the target volume) in April 1997.Based on the results of preliminary analysis of the 9602 protocol, two protocol were derived with effect from April 2001 into 1) the Phase I/II Clinical Trial of Carbon Ion Radiotherapy for Bone and Soft Tissue Tumors of the Head and Neck (Protocol 0006) designed as a dose escalation study for bone and soft-tissue tumors, and 2) the Phase II Clinical Trial of Carbon Ion Radiotherapy Combined with Chemotherapy for Mucosal Malignant Melanoma of the Head and Neck (Protocol 0007) for the treatment of malignant melanoma with concomitant chemotherapy. The 9602 and 0007 protocols have been carried out since November 2003 under the Highly Advanced Medical Technology