Know Cancer

forgot password

Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours

Phase 2
3 Years
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

Thank you

Trial Information

Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours



- Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in
pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors.


- Determine overall and relapse-free survival of patients treated with HART followed by
adjuvant combination chemotherapy comprising lomustine, cisplatin, and vincristine.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

- Radiotherapy: Patients undergo hyperfractionated accelerated radiotherapy (HART) twice
a day, 5 days a week, for 5 weeks.

- Adjuvant combination chemotherapy: Six weeks after the last radiotherapy dose, patients
receive oral lomustine once and cisplatin IV over 6 hours on day 1 and vincristine IV
on days 1, 8, and 15 . Treatment repeats every 6 weeks for 8 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 5

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Histologically proven nonpineal supratentorial primitive neuroectodermal tumors

- No supratentorial atypical teratoid/rhabdoid tumors or medulloepitheliomas

- Localized or metastatic disease

- Metastatic disease is defined as unequivocal evidence of supratentorial
metastases and/or spinal metastases on pre-operative or postoperative MRI scan
OR tumor cells seen on cytospin analysis of lumbar cerebrospinal fluid (stage
M1) performed between 15 days and 21 days after surgery

- Has undergone surgical resection within the past 4-6 weeks


- Able to cooperate with twice daily fractions of radiotherapy

- Hemoglobin ≥ 10 g/dL

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Neurologically stable (or improving) during the week before starting radiotherapy

- Lansky performance status 30-100% (for patients 1 to 16 years of age) OR

- Karnofsky performance status 30-100% (for patients over 16 years of age)

- Must be able to comply with the chemotherapy protocol (e.g., no hearing loss, renal

- No presence of active uncontrolled infection

- No previous malignant disease

- Not pregnant or nursing

- No syndrome with recognized potential for increased sensitivity to radiotherapy
and/or chromosomal fragility


- No previous chemotherapy or radiotherapy

- The patient should not be receiving steroids, if possible, at the start of
radiotherapy or should be on a stable or reducing dose of steroids during the week
before starting radiotherapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment

Safety Issue:


Principal Investigator

Frank Saran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive