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Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients (CONSET)

Primary Purpose

Pulmonary Fibrosis, Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Tamoxifen
Radiotherapy
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Breast cancer, Pulmonary fibrosis, tamoxifen, radiotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with large operable lesions (pT/cT > 5 cm) or locally advanced breast cancers undergoing modified radical mastectomy or breast conservative surgery-(BCS) who need adjuvant post operative radiotherapy
  • Patients post mastectomy requiring radiotherapy because of nodal positivity
  • Completed planned chemotherapy schedule
  • ER and/or PR positive patients
  • Patients decided to be put on tamoxifen
  • Patients reliable for follow up

Exclusion Criteria:

  • Patients with BCT who have pT1 or pT2 breast lesions (N0,N1)
  • Patients for palliative radiotherapy to the chest wall/breast/supraclavicular fossa
  • Any patient requiring radiation to the axillary or internal mammary area
  • Recurrent disease or metastatic disease
  • Patients on concurrent chemotherapy and radiation

Sites / Locations

  • Tata Memorial CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent Tamoxifen and Radiotherapy

Sequential radiotherapy and tamoxifen

Arm Description

ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.

ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.

Outcomes

Primary Outcome Measures

Development of Lung fibrosis

Secondary Outcome Measures

Locoregional failure and distant failure

Full Information

First Posted
May 8, 2009
Last Updated
August 27, 2011
Sponsor
Tata Memorial Hospital
Collaborators
Indian Council of Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00896155
Brief Title
Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients
Acronym
CONSET
Official Title
A Randomized Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy to Assess the Extent of Pulmonary Fibrosis and Disease Related Control and Survival in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Hospital
Collaborators
Indian Council of Medical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Two hundred and sixty patients with breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. Arm 1 will receive Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be given followed by tamoxifen sequentially. The patients will be stratified for the following factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and b) central lung distance (CLD) > 2 cm. Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum transforming growth factor (TGF) beta levels (baseline and at 6 months) and diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Breast Cancer
Keywords
Breast cancer, Pulmonary fibrosis, tamoxifen, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent Tamoxifen and Radiotherapy
Arm Type
Experimental
Arm Description
ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.
Arm Title
Sequential radiotherapy and tamoxifen
Arm Type
Active Comparator
Arm Description
ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
260 patients of breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. ARM 1 will receive Tamoxifen 20 Mg once daily given concurrently with radiotherapy while in ARM-2 radiotherapy followed by tamoxifen 20 mg once daily sequentially.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
260 patients of breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. ARM 1 will receive Tamoxifen 20 Mg once daily given concurrently with radiotherapy while in ARM-2 radiotherapy followed by tamoxifen 20 mg once daily sequentially.
Primary Outcome Measure Information:
Title
Development of Lung fibrosis
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Locoregional failure and distant failure
Time Frame
Three years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with large operable lesions (pT/cT > 5 cm) or locally advanced breast cancers undergoing modified radical mastectomy or breast conservative surgery-(BCS) who need adjuvant post operative radiotherapy Patients post mastectomy requiring radiotherapy because of nodal positivity Completed planned chemotherapy schedule ER and/or PR positive patients Patients decided to be put on tamoxifen Patients reliable for follow up Exclusion Criteria: Patients with BCT who have pT1 or pT2 breast lesions (N0,N1) Patients for palliative radiotherapy to the chest wall/breast/supraclavicular fossa Any patient requiring radiation to the axillary or internal mammary area Recurrent disease or metastatic disease Patients on concurrent chemotherapy and radiation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anusheel Munshi, MD
Organizational Affiliation
Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Center
City
Parel
State/Province
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anusheel Munshi, MD
Phone
-91-22-24177000
Ext
7144

12. IPD Sharing Statement

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Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients

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