Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01906112
Recruitment Status : Withdrawn (Low accrual and no further funding.)
First Posted : July 23, 2013
Last Update Posted : February 27, 2015
Sponsor:
Collaborator:
Vichaiyut Hospital
Information provided by (Responsible Party):
AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand

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
Carcinoma Breast Stage IV Procedure: Surgery for primary breast tumor. Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. Quality of life & Uncontrolled chest wall disease [ Time Frame: Five years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT01906112


Locations
Layout table for location information
Thailand
Division Head & Neck and Breast, Department of Surgery. Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Department of Surgery, Faculty of Medicine Vajira Hospital.
Dusit, Bangkok, Thailand, 10300
Phyathai 2 Hospital
PhyaThai, Bangkok, Thailand, 10400
National Cancer Institute
Ratchathewi, Bangkok, Thailand, 10400
Phramongkutklao Hospital
Ratchathewi, Bangkok, Thailand, 10400
Chonburi Cancer Hospital
Muang Chonburi, Chonburi, Thailand, 20000
Khon Kaen University
Muang, Khon Kaen, Thailand, 40002
Suratthani Cancer Hospital
Muang Suratthani, Suratthani, Thailand, 84100
Udon Thani Cancer Hospital
Muang Udon Thani, Udon Thani, Thailand, 41330
Sponsors and Collaborators
National Cancer Institute, Thailand
Vichaiyut Hospital
Investigators
Layout table for investigator information
Principal Investigator: AKANIST PIYAPANT, MD.,FRCST. Phyathai2 Hospital , Bangkok, Thailand
Publications:
Layout table for additonal information
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: July 23, 2013    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases