Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

This study has been completed.
Pediatric Brain Tumor Consortium
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 15, 2010
Last updated: February 4, 2014
Last verified: February 2014

This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.

Condition Intervention Phase
Brainstem Glioma
Drug: Capecitabine
Radiation: Radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 20 weeks) ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline to the end of the study (up to 20 weeks) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.

  • Percentage of Participants With a Tumor Response [ Time Frame: Baseline to the end of the study (up to 20 weeks) ] [ Designated as safety issue: No ]
    Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.

Enrollment: 45
Study Start Date: May 2007
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine + radiation therapy
Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Drug: Capecitabine
Capecitabine was supplied as film-coated tablets.
Other Name: Xeloda
Radiation: Radiation therapy
Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.

Detailed Description:

The open-label phase 2 study NO21125 (NCT01118377) evaluated the progression-free survival, safety, and pharmacokinetics of capecitabine (Xeloda®) rapidly disintegrating tablets and concomitant radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma. There were 2 phases to the study: A 9-week radiation phase, followed by a 2-week rest period, and a 9-week post-radiation phase. In the radiation phase, capecitabine 650 mg/m^2 was administered orally twice daily for 9 weeks. Concomitantly, patients received radiation therapy (180 cGy fractions) 5 days a week for a total target dose of 56 Gy. During the 9-week post-radiation phase of the study, capecitabine 1250 mg/m^2 was administered orally twice daily for 14 days followed by a 7-day rest period. This cycle of 14 days treatment followed by 7 days rest was repeated 2 additional times. The dose could be adjusted according to toxicity and body surface area.

The single-arm phase 1 study NO18517 (NCT00532948) assessed the maximum tolerated dose and dose-limiting toxicities of capecitabine (Xeloda®) administered concurrently with radiation therapy in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Patients in the phase 1 study NO18517 who were diagnosed with intrinsic brainstem glioma and who were treated at the established maximum tolerated dose of capecitabine 650 mg/m^2/dose twice a day were included in the analyses of the phase 2 study NO21125.

The efficacy and safety results of study NO21125 are reported below.


Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pediatric and adolescent patients ≥ 3 to < 18 years of age.
  • Patients must have a newly diagnosed non-disseminated intrinsic infiltrating brainstem glioma.
  • Karnofsky Performance Scale (if > 16 years of age) or Lansky Performance Score (if ≤ 16 years of age) ≥ 50% assessed within 2 weeks prior to registration to study.
  • Patients must not have received any prior chemotherapy or bone marrow transplant for the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.
  • Adequate organ function.

Exclusion Criteria:

  • Patients receiving any other anticancer or experimental drug therapy.
  • Patients with uncontrolled infection.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  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 identifier: NCT01118377

United States, California
San Francisco, California, United States, 94143-0780
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Illinois
Chicago, Illinois, United States, 60614
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15261
United States, Tennessee
Memphis, Tennessee, United States, 38015
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Pediatric Brain Tumor Consortium
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01118377     History of Changes
Other Study ID Numbers: NO21125, PBTC-030
Study First Received: April 15, 2010
Results First Received: September 30, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 25, 2015