Peritoneal Surface Malignancy - Ethical Considerations

I. Introduction II.Principles of Management III. Current Methodologies for Delivery of Intraperitoneal Chemotherapy
IV. Clinical Results of Treatment V. Ethical Considerations in Clinical Studies with Peritoneal Surface Malignancy VI. References

V. Ethical Consideration in Clinical Studies with Peritoneal Surface Malignancy

The sequence of events that should accompany a new program in peritoneal surface malignancy have not yet been defined. The requirements for formal institutional review board approval will vary from one institution to another. Guidelines for an evolution of treatment strategies that allows for persistent clinical research may occur as follows:

Without exception, adjuvant intraperitoneal chemotherapy studies in patients with primary gastrointestinal cancer must be randomized and require review by a research board. An exception to the need for randomization is resected pancreas cancer. Also, when a group first attempts to initiate treatment plans with intraperitoneal chemotherapy, the learning curve associated with a new technology is best approached by a start up protocol approved by an institutional review board. This forces the group to standardize the methods and familiarize themselves with the experience of others. Selection criteria to treat patients with a reasonable likelihood of benefit must be evident. An omnibus protocol is suggested which allows aggressive cytoreduction and perioperative intraperitoneal chemotherapy in patients with no systemic dissemination and small volume peritoneal seeding from recurrent colorectal cancer, resected primary gastric cancer and resected primary or recurrent abdomino-pelvic sarcoma. This omnibus protocol should be utilized on a limited time period to treat 10 to 20 patients.

Formal protocols should not be required for the treatment of debilitating ascites. Also the long term survival of patients with established peritoneal surface malignancy that has a small volume and limited distribution has been established. After completing the start up protocols, phase II clinical studies on this group of patients by an oncologic team that has demonstrated experience should proceed without the need for further institutional review board approval. The peritoneal surface spread of most gastrointestinal cancers that have a low Peritoneal Cancer Index and that after surgery have a completeness of cytoreduction score of 0 or 1 should be routinely treated according to standardized intraperitoneal chemotherapy protocols.