) We have devised a way to markedly increase cisplatin (DDP) drug delivery to head and neck carcinomas based on the pharmacologic principles of intra-arterial(IA) infusion DDP neutralization. When combined with concomitant radiotherapy, 4 consecutive weekly infusions of DDP can be administered consistently at a dose intensity of 150 mg/m2/week. Acronymed, RADPLAT, this targeted chemoradiation strategy has proven to be extremely effective and well tolerated in a pilot study done at two academic centers. Since there are potential risks inherent with this technology necessitating the coordinated expertise of a multidisciplinary oncology team and a skilled interventional radiologist, there is now an important need to determine whether this treatment can be expanded with reproducible effects to other centers.
The specific aim of our proposal is to determine whether a phase II trial of the RADPLAT program can be conducted in a multi-institutional setting under rigorous quality control guidelines. The important endpoints will be 1) percentage of patients capable of receiving the complete treatment, 2) complete response rate, 3) toxicity rate, 4) quality of life scores, 5) rate and pattern of recurrence, and 6) survival. Through a contractual agreement with the Biostatistics Management Center of the Radiation Therapy Oncology Group (RTOG), data collection and quality assurance monitoring will be done centrally by their experienced staff. Achievement of the specific aim would help to define whether the RADPLAT technology is transportable and effective. The results would enable us to assess the feasibility of a phase III randomized trial to determine whether this approach offers a survival advantage to a group of cancer patients who otherwise have a poor prognosis and marked functional impairment. The targeted supradose chemoradiation strategy may also have broader applications to include other organ-specific malignancies.
| Samant, S; Robbins, K T; Kumar, P et al. (2001) Bone or cartilage invasion by advanced head and neck cancer: intra-arterial supradose cisplatin chemotherapy and concomitant radiotherapy for organ preservation. Arch Otolaryngol Head Neck Surg 127:1451-6 |
