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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01419067
First received: August 16, 2011
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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. Proton therapy will include 30 treatment fractions administered 5 days per week. Weekly imaging will be a requirement to monitor for cyst expansion and target volume deformation.


Condition Intervention Phase
Craniopharyngioma
Procedure: Radical Surgery or Limited Surgery
Radiation: Proton Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton therapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Reducing the clinical target volume margin to 5mm and using proton therapy, with the goal of reducing side effects from irradiation, will not increase the rate of tumor progression compared to photon therapy with a similar or larger clinical target volume margin.


Secondary Outcome Measures:
  • Estimate the cumulative incidence of cystic intervention and the event-free survival distribution for children and young adults with craniopharyngioma treated with limited surgery and proton therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    This will be improved by models based on clinical and treatment factors and longitudinal measures of CNS effects.

  • Estimate the distributions of progression-free survival and overall survival for children and young adults with craniopharyngioma treated only with primary surgical resection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    This will be improved by models based on clinical and treatment factors and longitudinal measures of CNS effects


Estimated Enrollment: 140
Study Start Date: August 2011
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Radical Surgery or Limited Surgery
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.
Radiation: Proton Therapy
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. Radiation will be prescribed to the planning target volume which will include the tumor bed encompassed by an anatomically defined margin meant to include subclinical microscopic disease, and an additional geometric margin that is meant to account for the technical limitations associated with planning and administering daily fractionated treatment. Making radiation therapy safer through the use of proton therapy.

Detailed Description:

The primary objectives of this study :

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.

The Secondary Objectives of this study:

  • To estimate the cumulative incidence of cystic intervention and the event-free survival distribution for children and young adults with craniopharyngioma treated with limited surgery and proton therapy using a 5mm clinical target volume margin; and compare the distributions of progression-free, event-free and overall survival with the distributions for the St. Jude Children's Research Hospital cohort of 93 patients on which the design of this trial is based.
  • To estimate the distributions of progression-free survival and overall survival for children and young adults with craniopharyngioma treated only with primary surgical resection and to compare these distributions with the distributions observed for patients treated with limited surgery and proton therapy.
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419067

Contacts
Contact: Thomas E Merchant, DO, PhD 1-866-278-5833 info@stjude.org

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Daniel J. Indelicato, MD    904-588-1442      
Principal Investigator: Daniel J. Indelicato, MD         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Thomas E Merchant, DO, PhD    866-278-5833    info@stjude.org   
Principal Investigator: Thomas E Merchant, DO, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Thomas E Merchant, DO, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01419067     History of Changes
Other Study ID Numbers: RT2CR
Study First Received: August 16, 2011
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Proton Therapy
Radical resection

Additional relevant MeSH terms:
Craniopharyngioma
Adamantinoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014