SarcomaTOSSNCT00384735
An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial
An observational study of Sarcoma, run by Terry Fox Foundation at 1 site in India.
Trial summary
The purpose of this study is to evaluate the impact on overall survival of an intensive follow-up protocol (as practiced today at TMH) against a more cost effective follow-up protocol in patients operated for extremity sarcoma. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Sarcoma
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2006to 31 Dec 2015
- Phase
- Observational
- 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 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated for primary or recurrent extremity bone \& soft tissue sarcomas
Who may be able to join
- Patients operated for primary or recurrent extremity bone \& soft tissue sarcomas.(both limb salvage and amputations)
- Non Metastatic at presentation.
- Patients reliable for follow-up.
Who cannot join
- Non-extremity sarcomas.
- Metastatic at presentation
- Patients unreliable for follow up.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the impact on overall survival of an intensive follow-up protocol (as practiced today at TMH) against a more cost effective follow-up protocol in patients operated for extremity sarcoma.
Read the detailed description
Follow up studies are performed for a variety of reasons. The detection of a recurrence of the index lesion is the foundation of surveillance. Detection of other medical conditions is a secondary benefit. Psychologically, follow up testing can serve as a source of reassurance. Whether an increased frequency of follow up and the use of various expensive imaging modalities for screening and early detection of recurrence actually results in improving overall survival of patients with extremity sarcomas is a question that remains as yet unanswered. Currently followed post -operative surveillance regimes are empirical and vary widely from centre to centre. Allocation of limited health funding should be guided by evidence based recommendations rather than empirical beliefs. An ideal surveillance regime should meet the criteria of easy implementation, accuracy and cost effectiveness.
In a vast country like India where patients often travel thousands of kilometers in their search for quality medical care the frequency of routine follow up visits is as important as studying the role of expensive screening modalities while drawing up guidelines for cost effective follow up strategies.
This study, a prospective randomized controlled trial, attempts to outline guidelines regarding the role of follow up vis a vis frequency and the use of various imaging modalities for early detection of recurrence in improving overall survival of patients with extremity sarcomas.
- Conditions
- Sarcoma
- Keywords
- bone tumor, soft tissue tumor
- Medical subject headings
- Sarcoma, Bone Neoplasms, Soft Tissue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1A | Intensive - 3 monthly follow up | |
| 1B | Intensive - 6 monthly follow up | |
| IIA | Cost Effective - 3 monthly follow up | |
| IIB | Cost Effective - 6 monthly follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Minimum 2 years
Secondary outcomes (1)
Disease free survival
Measured: Minimum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study start1 Jan 2006
- Primary completion30 Jun 2010
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terry Fox Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Tata Memorial Hospital
- Responsible party
- Principal investigator, Dr. Ajay Puri, Terry Fox Foundation
- Investigators
- Dr. Ajay Puri, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384735
- Sponsor's protocol ID
- TOSS
- Acronym
- TOSS
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2006
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puri A, Gulia A, Hawaldar R, Ranganathan P, Badwe RA. Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. Clin Orthop Relat Res. 2014 May;472(5):1568-75. doi: 10.1007/s11999-013-3385-9. Epub 2013 Nov 19.
PubMed 24249538
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00384735
- Acronym / sponsor ID
- TOSS / TOSS
- Conditions
- Sarcoma
- Keywords
- bone tumor, soft tissue tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Terry Fox FoundationUniversity, hospital or other
- Collaborators
- Tata Memorial Hospital
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 6 Oct 2006 (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.
The purpose of this study is to evaluate the impact on overall survival of an intensive follow-up protocol (as practiced today at TMH) against a more cost effective follow-up protocol in patients operated for extremity sarcoma.
Detailed description
Follow up studies are performed for a variety of reasons. The detection of a recurrence of the index lesion is the foundation of surveillance. Detection of other medical conditions is a secondary benefit. Psychologically, follow up testing can serve as a source of reassurance. Whether an increased frequency of follow up and the use of various expensive imaging modalities for screening and early detection of recurrence actually results in improving overall survival of patients with extremity sarcomas is a question that remains as yet unanswered. Currently followed post -operative surveillance regimes are empirical and vary widely from centre to centre. Allocation of limited health funding should be guided by evidence based recommendations rather than empirical beliefs. An ideal surveillance regime should meet the criteria of easy implementation, accuracy and cost effectiveness.
In a vast country like India where patients often travel thousands of kilometers in their search for quality medical care the frequency of routine follow up visits is as important as studying the role of expensive screening modalities while drawing up guidelines for cost effective follow up strategies.
This study, a prospective randomized controlled trial, attempts to outline guidelines regarding the role of follow up vis a vis frequency and the use of various imaging modalities for early detection of recurrence in improving overall survival of patients with extremity sarcomas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1A | – | –Intensive - 3 monthly follow up |
| 1B | – | –Intensive - 6 monthly follow up |
| IIA | – | –Cost Effective - 3 monthly follow up |
| IIB | – | –Cost Effective - 6 monthly follow up |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated for primary or recurrent extremity bone \& soft tissue sarcomas
Key inclusion criteria (3 listed)
- Patients operated for primary or recurrent extremity bone \& soft tissue sarcomas.(both limb salvage and amputations)
- Non Metastatic at presentation.
- Patients reliable for follow-up.
Key exclusion criteria (3 listed)
- Non-extremity sarcomas.
- Metastatic at presentation
- Patients unreliable for follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: Minimum 2 years
1 secondary outcome
Disease free survival
Time frame: Minimum 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 24249538Puri A, Gulia A, Hawaldar R, Ranganathan P, Badwe RA. Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. Clin Orthop Relat Res. 2014 May;472(5):1568-75. doi: 10.1007/s11999-013-3385-9. Epub 2013 Nov 19.
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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.
Dr. Ajay Puri 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?
An observational study of Sarcoma, run by Terry Fox Foundation 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Minimum 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384735, which also lists 1 linked publication.
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 8 Oct 2020.