Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.
Sponsor
National Cancer Institute, Thailand (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01906112
Collaborator
Vichaiyut Hospital (Other)
0
9
2
72
0
0
Study Details
Study Description
Brief Summary
The purpose of this study is to determine benefits of surgery for the primary in patients with breast cancer stage IV in randomized controlled study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV - A Prospective Randomized Multicenter Controlled Trial
Study Start Date
:
Aug 1, 2013
Anticipated Primary Completion Date
:
Aug 1, 2014
Anticipated Study Completion Date
:
Aug 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Controlled No surgery for primary breast tumor. |
|
| Experimental: Study Surgery for primary breast tumor. |
Procedure: Surgery for primary breast tumor.
Complete resection of primary breast tumor(Lumpectomy or mastectomy)
|
Outcome Measures
Primary Outcome Measures
- Overall survival [Five years]
Secondary Outcome Measures
- Quality of life & Uncontrolled chest wall disease [Five years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy breast cancer stage IV patients with resectable primary breast tumor.
-
Resectable breast cancer stage IV patients who well response of visceral metastasis to systemic therapy and fit for surgery.
Exclusion Criteria:
-
Breast cancer stage IV patients with local complication of primary breast tumor that require surgery for palliation such as uncontrolled bleeding,large and non-healing ulcer or intractable pain.
-
Breast cancer stage IV patients with unresectable primary breast tumor or extensive chest wall disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital | Bangkok Noi | Bangkok | Thailand | 10700 |
| 2 | Department of Surgery, Faculty of Medicine Vajira Hospital. | Dusit | Bangkok | Thailand | 10300 |
| 3 | Phyathai 2 Hospital | PhyaThai | Bangkok | Thailand | 10400 |
| 4 | National Cancer Institute | Ratchathewi | Bangkok | Thailand | 10400 |
| 5 | Phramongkutklao Hospital | Ratchathewi | Bangkok | Thailand | 10400 |
| 6 | Chonburi Cancer Hospital | Muang Chonburi | Chonburi | Thailand | 20000 |
| 7 | Khon Kaen University | Muang | Khon Kaen | Thailand | 40002 |
| 8 | Suratthani Cancer Hospital | Muang Suratthani | Suratthani | Thailand | 84100 |
| 9 | Udon Thani Cancer Hospital | Muang Udon Thani | Udon Thani | Thailand | 41330 |
Sponsors and Collaborators
- National Cancer Institute, Thailand
- Vichaiyut Hospital
Investigators
- Principal Investigator: AKANIST PIYAPANT, MD.,FRCST., Phyathai2 Hospital , Bangkok, Thailand
Study Documents (Full-Text)
None provided.More Information
Publications
- Gnerlich J, Jeffe DB, Deshpande AD, Beers C, Zander C, Margenthaler JA. Surgical removal of the primary tumor increases overall survival in patients with metastatic breast cancer: analysis of the 1988-2003 SEER data. Ann Surg Oncol. 2007 Aug;14(8):2187-94. Epub 2007 May 24.
- Khan SA, Stewart AK, Morrow M. Does aggressive local therapy improve survival in metastatic breast cancer? Surgery. 2002 Oct;132(4):620-6; discussion 626-7.
- Neuman HB, Morrogh M, Gonen M, Van Zee KJ, Morrow M, King TA. Stage IV breast cancer in the era of targeted therapy: does surgery of the primary tumor matter? Cancer. 2010 Mar 1;116(5):1226-33. doi: 10.1002/cncr.24873.
- Nguyen DH, Truong PT, Alexander C, Walter CV, Hayashi E, Christie J, Lesperance M. Can locoregional treatment of the primary tumor improve outcomes for women with stage IV breast cancer at diagnosis? Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):39-45. doi: 10.1016/j.ijrobp.2011.11.046. Epub 2012 Feb 11.
- Rapiti E, Verkooijen HM, Vlastos G, Fioretta G, Neyroud-Caspar I, Sappino AP, Chappuis PO, Bouchardy C. Complete excision of primary breast tumor improves survival of patients with metastatic breast cancer at diagnosis. J Clin Oncol. 2006 Jun 20;24(18):2743-9. Epub 2006 May 15.
- Shien T, Kinoshita T, Shimizu C, Hojo T, Taira N, Doihara H, Akashi-Tanaka S. Primary tumor resection improves the survival of younger patients with metastatic breast cancer. Oncol Rep. 2009 Mar;21(3):827-32.
Responsible Party:
AKANIST PIYAPANT, MD.,FRCST.,
Surgical Oncologist.,
National Cancer Institute, Thailand
ClinicalTrials.gov Identifier:
NCT01906112
Other Study ID Numbers:
- 17_2013RC_IN305
First Posted:
Jul 23, 2013
Last Update Posted:
Feb 27, 2015
Last Verified:
Feb 1, 2015
Additional relevant MeSH terms: