RT2CR: Limited Surgery and Proton Beam Radiation Therapy in Treating Younger Patients with Brain Tumors

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

Categories:

Brain Tumor

Radiology

Phase I/II

Diseases Treated:

Craniopharyngioma

Eligibility Overview:

  • 21 years of age or younger
  • Diagnosis of craniopharyngioma 
  • Has not been previously treated with radiation therapy
  1. Brief Summary

    The goal of this study is to determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume margin in combination with proton therapy.

    Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Irradiated patients will undergo a series of evaluations designed to evaluate the effects of proton therapy.

    Similar evaluations will be performed on patients treated with radical surgery.

    Primary Objective

    To estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton therapy using a 5mm clinical target volume margin while monitoring for excessive central nervous system necrosis.

    Trial Outline

    Patients will be selected for radical surgery based on the neurosurgeon's assessment that a Gross-Total Resection may be achieved with acceptable post-operative morbidity. The goal of surgical intervention in this study should be to facilitate tumor control, keeping surgical morbidity to a minimum.

    Common indications for surgical intervention directed at the tumor will include establishing a tissue diagnosis, tumor control by radical resection, relieving tumor mass effect to reduce symptoms and decreasing the target volume for proton therapy by planned volume reduction surgery. These indications can be achieved through radical or limited surgery.

    Proton therapy will be started once a final treatment plan has been developed and approved. There is no time limit for the interval from enrollment to when proton therapy commences. The total prescribed dose will be 54CGE administered at 1.8CGE per fraction. The time course of administration will be one fraction per day, 5 days per week, for a period of 6 weeks.

    Weekly imaging will be a requirement to monitor for cyst expansion and target volume deformation.

    Study Arms

    Craniopharyngioma Patients

    Craniopharyngioma patients will have limited surgery and a 5mm clinical target volume margin in combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years.

    Interventions

    • Procedure: Radical Surgery or Limited Surgery
    • Radiation: Proton Therapy

    Eligibility Criteria

    Inclusion Criteria:

    • Craniopharyngioma diagnosed by histology, cytology or neuroimaging
    • Patients ages 0-21 years at the time of diagnosis

    Exclusion Criteria:

    • Prior history of fractionated radiation therapy
    • Prior treatment with intracystic P-32, intracystic bleomycin or radiosurgery
    • Pregnant females are excluded (Radiation has teratogenic or abortifacient effects)

    Study Design   

    • Endpoint Classification: Safety/Efficacy Study
    • Intervention Model: Single Group Assignment
    • Masking: Open Label
    • Primary Purpose: Treatment
  2. About this clinical trial

    RT2CR is a clinical trial for children, adolescents, and young adults with a rare type of brain tumor called craniopharyngioma. Although many patients may be cured from their tumor with surgery and/or radiation therapy, these treatments may cause some serious side effects. Most of the side effects from surgery happen during or immediately after surgery, while most of the side effects from radiation therapy happen over time.

    Some of the serious side effects of surgery and/or radiation treatment include problems with:

    • Cognitive function – intelligence, memory, attention, learning and behavior
    • Hormone function – growth, thyroid, stress and pubertal hormones and hormones responsible for salt and fluid balance
    • Neurological function – vision, hearing, motor, sensory and coordination

    Better treatments with fewer long-term side effects are needed, which is why St. Jude is offering this clinical trial. It is thought that if patients with craniopharyngioma can be successfully treated with proton therapy (a newer type of radiation treatment) they may have fewer serious side effects than those associated with conventional radiation treatment.

    Purpose of this clinical trial

    The main goal of this study is to learn if proton therapy is successful in treating patients with craniopharyngioma and reduce side effects compared to other forms of radiation therapy. Proton therapy is a newer form of radiation therapy that delivers high radiation doses directly to tumors with potentially less harm to normal tissue.

    Researchers also want to study and compare the side effects of surgery and proton therapy.

    Treatment

    Based on the size and location of the craniopharyngioma, as well as its growth into nearby tissues, your child will receive one of the following treatments:

    • Complete surgery - complete removal of the tumor and no further treatment is needed
    • Limited surgery – partial removal of the tumor to help reduce symptoms or to obtain a tumor sample for diagnosis (biopsy). Limited surgery is usually followed by proton therapy.
    • No surgery – there are special circumstances cases when surgery is not necessary and treatment is proton therapy only.

    Eligibility overview

    • 21 years of age or younger
    • Diagnosis of craniopharyngioma
    • Has not been previously treated with radiation therapy
  3. RT2CR  Quick View
    Sponsor St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier: NCT01419067
    Trial start date: August 2011
    Estimated enrollment 140
    Study type Interventional
    Study phase Phase 2
    Condition Craniopharyngioma
    Ages Up to 21 years
    Principal investigator Thomas E. Merchant, DO, PhD
    Study sites St. Jude Children's Research Hospital and University of Florida Health Proton Therapy Institute
    For a consultation or to discuss RT2CR St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Thomas E. Merchant, DO, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

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