Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor
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|ClinicalTrials.gov Identifier: NCT00085098|
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : November 6, 2013
Last Update Posted : March 15, 2017
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor.
PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Central Nervous System Tumor||Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Radiation: radiation therapy||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Experimental: Regimen A (radiotherapy only)
Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week
Experimental: Regimen B (chemotherapy plus radiotherapy)
Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.
Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.
Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF), subcutaneous (SC) or IV beginning on day 4 and continuing until blood counts recover.
Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A. Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks
Given by infusion or injection
Other Names:Drug: carboplatin
Given IV over 1 hour
Other Names:Drug: cisplatin
Given IV over 6 hours
Other Names:Drug: cyclophosphamide
Given IV over 1 hour
Other Names:Drug: etoposide
Given IV over 2 hours
Other Names:Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week
- Event-free Survival [ Time Frame: Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years ]
Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up.
QEs: 1)disease progression, defined as increase >= 40% in tumor volume or >= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause.
Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol's primary objective.
NOTE: Reported data are through May 2009 (see Caveats section).
- Response [ Time Frame: Up to 5 years ]
- Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: From the beginning of treatment, assessed up to 5 years ]The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. Estimates will be obtained using life-table methods with an event defined as the first occurrence of a key acute or sub-acute toxicity. Patients who have progression or recurrence of disease will be censored in these analyses. The precision of the estimates of toxicity rate can be approximated by an analysis of binomial proportions.
- Quality of Life (QOL) and Neurocognitive Assessment (NP) [ Time Frame: Up to 2 years ]The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. Comparisons of each treatment group with the standard population mean, using a two-sided test with Type I error 0.025 (an adjustment for multiple comparison) will be able to detect differences from the standard mean that are 20% smaller.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085098
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|Study Chair:||Jeffrey C. Allen, MD||New York University School of Medicine|