Hyperthermia in adjuvant therapy of locally advanced carcinoma of the rectum. Study protocol and initial clinical experience

Since January 1992 a feasibility study was set up to establish the possible role of pelvic hyperthermochemotherapy for the local control of rectal cancer. Patients with resectable rectal cancer (clinical stage III-IV) are eligible for the study. Only patients submitted to abdominoperineal resection with or without extended pelvic linfoadenectomy (PLND) and/or resection of contiguous organs are included in the initial pilot phase of the study. Until now, two patients with stage III rectal cancer submitted to abdominoperineal resection and PLND have been treated. A single (40 mg) push of MMC was injected in the circuit with median local temperature of 46.0 +/- 0.3 and 45.9 +/- 0.5 degrees C and the pelvis was perfused for 60 min. There were no local or systemic complications. The ratio between the pelvis and plasma AUCs showed a high local pharmacokinetic advantage. The treatment can contribute to complete the standard protocols of adjuvant therapy. Since the simple decrease of local recurrence could represent an important clinical aim, this experience, even initial, supports us to continue the study.