Protocol

RT2CR: A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma after Radical Resection

Diseases

Brain Tumor : Craniopharyngioma

Description

Craniopharyngioma is a rare brain tumor that affects children. It often grows in an area of the brain called the suprasellar region. This is located near the pituitary gland, the primary blood supply to the brain and the nerves that carry vision. This type of tumor may injure vital parts of the brain or block the flow of cerebrospinal fluid. The results may be severe headache, loss of vision or deficits in movement, coordination and sensation. When the hypothalamus and pituitary gland are affected, hormones may be affected resulting in deficiencies in growth and development and the balance of fluids and salts in the body.

The treatment for craniopharyngioma may be radical surgery or limited surgery and radiation therapy. When radiation therapy is required, this study will use proton therapy, a newer form of radiation therapy. Physicians participating in this study will help the patient decide if radical surgery or limited surgery and proton therapy would be the preferred treatment. Radical surgery is considered to be the successful removal of the tumor after which no further treatment is required. When radical surgery is attempted and unsuccessful, proton therapy is required. Based on the location and extent of the tumor, some patients are not candidates for radical surgery. These patients will be treated with limited surgery. Limited surgery is defined as surgery performed to partially remove or decompress the tumor to establish a diagnosis or to reduce the symptoms caused by the tumor. The goal of limited surgery is to limit the risks of surgical complications. After limited surgery, radiation therapy will be required.

Surgery and radiation therapy have similar risks. Most of the side effects from surgery occur during or immediately following surgery. Most of the side effects from proton therapy happen over time. Primary concerns are the effects of treatment on cognitive function (intelligence, memory, attention, learning and behavior), hormone function (growth, thyroid, stress and pubertal hormones and hormones responsible for salt and fluid balance), and neurological function (vision, hearing, motor, sensory and coordination). In combination, the side effects may result in sleep disturbances, impairment of performance and reduced quality of life.


Objectives

The main goal of this study is to learn if proton therapy will effectively treat patients with a brain tumor known as craniopharyngioma and reduce side effects compared to traditional radiation therapy.


Eligibility

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).


Contact

Thomas E. Merchant, DO, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.