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Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients
Plain-language guide to NCT00309478: phase 3 randomized trial of Goserelin, 1099 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00309478
- Phase
- phase 3
- Status
- completed
- Start
- 1990-12
- Completion (planned or actual)
- 2004-06
- Participants
- 1099 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Early-stage Breast Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Goserelin.
It had two arms (groups): 2 (CMF scheme) (experimental) and 1 (Nol + Zol) (experimental).
6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil).
Zoladex (3 years) combined with Nolvadex (5 years).
The registry classes the interventions as drug.
Who Took Part
The registry lists 1099 actual participants took part.
It was open to women only aged from 19 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Hormone receptor-positive status. More than 6 histologically examined lymph nodes. Hematopoiesis: \> 3500/µl leukocytes, \> 100,000/µl thrombocytes. Hepatic function: GOT \</= 2.5 x UNL. Metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar.
The full record lists 13 inclusion and 9 exclusion criteria; among the exclusions: male patients; pregnancy or lactation; lacking compliance or understanding of the disease.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.
The Goserelin group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.
It started in 1990-12 with completion listed for 2004-06.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Disease-free survival. Overall survival.
It also tracked 1 secondary outcome, for example Toxicities.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Goserelin in 1099 people.
With 1099 participants it is a large trial for this field.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Goserelin compound page, all human trials.
Our Notes on the Compound
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.