Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care | Closed | 18 and over | Other | RMNHS-1489 EU-20004, NCT00005600 |
Objectives
- Compare high vacuum drainage vs low vacuum drainage vs simple tube drainage in patients undergoing axillary surgery for stage I or II breast cancer.
Entry Criteria
Disease Characteristics:
- Diagnosis of resectable stage I or II breast cancer
- Planned primary surgery of level II or III axillary dissection in
association
with one of the following:
- Wide local excision (may be done through separate incision)
- No breast surgery
- Bilateral surgery allowed
- No prior mastectomy
- No immediate breast reconstruction using implants, latissimus dorsi, or rectus abdominus myocutaneous flaps at primary operation
- Hormone receptor status:
- Not specified
Prior/Concurrent Therapy:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
- No prior axillary surgery
Patient Characteristics:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant
Expected Enrollment
A total of 200 patients will be accrued for this study.
Outline
This is a randomized study.
Patients undergo axillary dissection, then are randomized to one of three axillary drainage systems.
- Arm I: Patients receive high vacuum drainage.
- Arm II: Patients receive low vacuum drainage.
- Arm III: Patients receive simple tube drainage (no vacuum).
All drains are removed when daily volumes are below 30 mL or at 5 days after surgery, regardless of drain volume.
Patients are followed at day 10 and at 3 months.
Trial Lead Organizations
Royal Marsden - London
 | | | ||
| Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), Protocol chair | |
| ||
| ||||
| Registry Information | ||
| ||
| Official Title | Optimum Drainage of the Axilla after Lymph Node Dissection: A Randomized Prospective Study | |
| ||
| Trial Start Date | 1997-11-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00005600 | |
| ||
| Date Submitted to PDQ | 2000-03-01 | |
| ||
| Information Last Verified | 2005-12-05 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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