Pulmonary FibrosisPhase 3CONSETNCT00896155
Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients
A Phase 3 study testing Tamoxifen and Radiotherapy in people with Pulmonary Fibrosis and Breast Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pulmonary Fibrosis, Breast Cancer
- What is being tested?
- Tamoxifen and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2008to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Center
Parel, Mumbai, 400012
Anusheel Munshi, MD, -91-22-24177000 ext. 7144
About this study
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
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).
- Conditions
- Pulmonary Fibrosis, Breast Cancer
- Being tested
- Tamoxifen, Radiotherapy
- Keywords
- Breast cancer, Pulmonary fibrosis, tamoxifen, radiotherapy
- Medical subject headings
- Pulmonary Fibrosis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
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.
RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Tamoxifen and Radiotherapy | Experimental | ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years. Receives: Drug: Tamoxifen; Radiation: Radiotherapy |
| Sequential radiotherapy and tamoxifen | Active comparator | ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years. Receives: Drug: Tamoxifen; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Lung fibrosis
Measured: Three years
Secondary outcomes (1)
Locoregional failure and distant failure
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Anusheel Munshi, Tata Memorial Hospital
- Investigators
- Anusheel Munshi, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896155
- Sponsor's protocol ID
- 349
- Acronym
- CONSET
- Status last verified
- Aug 2011
- First submitted
- 8 May 2009
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00896155
- Acronym / sponsor ID
- CONSET / 349
- Conditions
- Pulmonary Fibrosis, Breast Cancer
- Keywords
- Breast cancer, Pulmonary fibrosis, tamoxifen, radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- Indian Council of Medical Research
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent Tamoxifen and Radiotherapy | Experimental | Drug: Tamoxifen, Radiation: RadiotherapyARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years. |
| Sequential radiotherapy and tamoxifen | Active comparator | Drug: Tamoxifen, Radiation: RadiotherapyARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamoxifen260 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. | Drug | Concurrent Tamoxifen and Radiotherapy, Sequential radiotherapy and tamoxifen |
| Radiotherapy260 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. | Radiation | Concurrent Tamoxifen and Radiotherapy, Sequential radiotherapy and tamoxifen |
Primary outcome
Development of Lung fibrosis
Time frame: Three years
1 secondary outcome
Locoregional failure and distant failure
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anusheel Munshi, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamoxifen and Radiotherapy in people with Pulmonary Fibrosis and Breast Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Lung fibrosis (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.