SarcomasTOSSNCT05827458
An Adequate Cost Effective Follow Up Protocol For Bone and Soft Tissue Sarcomas
An observational study of Sarcomas, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Bone and soft tissue sarcomas are rare tumors, accounting for approximately 1% of all adult malignancies. The majority of bone and soft tissue sarcomas occur in the extremities. After treatment of the primary tumor, 40 % to 60% of the patients will develop local or distant recurrent disease. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Sarcomas
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2006to Jan 2016
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 500 PATIENTS OVERALL. 250 PATIENTS ON INTENSIVE GROUP 250 PATIENTS ON COST EFFECTIVE GROUP
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
Official title: An Adequate Cost Effective Follow Up Protocol For Bone and Soft Tissue Sarcomas: - A Prospective Randomized Trial
Bone and soft tissue sarcomas are rare tumors, accounting for approximately 1% of all adult malignancies. The majority of bone and soft tissue sarcomas occur in the extremities. After treatment of the primary tumor, 40 % to 60% of the patients will develop local or distant recurrent disease. The ultimate determinant of survival in patients with bone and soft tissue sarcomas is the development of distant metastasis. Modern multimodality therapy has improved patient survival; hence follow-up surveillance strategies are becoming increasingly important with significant clinical and fiscal implications. However, the ideal postoperative protocol vis a vis frequency and appropriate screening modalities for these uncommon neoplasms remains ill-defined. Although guidelines have been proposed for follow-up of patients , there is a paucity of data in medical literature on the effectiveness of these recommendations. A prospective randomized controlled trial to evaluate the effectiveness of follow up strategies in picking up disease recurrence and their role in influencing overall survival would go a long way in answering some of these questions.
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 bone and soft tissue 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.
This study 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 bone and soft tissue sarcomas . 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. Though it is well accepted that in bone and soft tissue sarcomas the majority of recurrences either local or distant would occur in the first two years there has been no study to gauge the effectiveness of an intensive three monthly follow up during this initial "risk" period in improving overall survival . We have therefore further attempted to stratify the patients in both arms into Group A and Group B. Compared to Group A patients, Group B patients would have two less follow up visits per year in the initial two years of follow up. This could help to further reduce both the cost and loss of working man hours in these patients.
Correlation between local failure and the development of metastatic disease remains controversial. Though Lewis et al have suggested that there is strong association of local recurrence with the development of subsequent metastasis and tumor mortality, various prospective randomized trials have failed to show that better local control improves survival.
Though an MRI is advantageous in the initial evaluation of STS its utility in the diagnosis of patients with recurrent lesions, including its comparison with physical examination alone has yet to be documented. Distortion of the anatomy and fibrosis because of prior surgery and radiotherapy makes interpretation of post operative images difficult. In a series of 150 patients from the Rosewall Park Cancer Institute almost all the local recurrences were detected on physical examination and 86% of these were deemed resectable .Does an MRI actually help in the accurate early detection of local recurrence and if so does this early detection and subsequent intervention impact on overall survival? Its use has to be assessed critically with regard to cost effectiveness and efficacy.
Patients with extremity bone and soft tissue sarcomas are more likely to have distant metastasis as their initial site of recurrence . Pulmonary metastasis comprises most of these distant failures. The benefit of detection of recurrence depends on the availability of therapeutic interventions that can prolong survival. The occurrence rate of isolated pulmonary metastasis is in the range of 20% to 40% and there is a potential to salvage these patients. Though Huth et al felt that the impact of resection of pulmonary metastasis on improving survival of patients with soft tissue sarcoma was minimal a retrospective study by Geel et al recommended surgical excision of lung metastasis in order to improve survival. CT scanning of the chest is known to be more sensitive than CXR in detecting lung lesions but its specificity in detecting metastatic lesions is lower. The role of CT scanning in the surveillance of metastatic disease is therefore not clear. Whooley et al do not recommend CT scanning of the chest as a surveillance technique because of the high accuracy of CXR in recurrence detection in their series .
There is enough evidence in literature from other solid tumor types i.e. breast cancer, colorectal cancer and melanoma that challenges the usefulness of multiple follow up imaging tests in terms of efficacy , cost effectiveness and survival benefit .Whether the same surmise holds true for extremity soft tissue sarcoma is a matter of debate. Kane states that for soft tissue sarcomas, patient education and follow up visits with thorough history and physical examination will detect the vast majority of recurrent disease . Goel in his article on "Costs of follow-up after potentially curative treatment for extremity soft-tissue sarcoma" states that several guidelines have been proposed for extremity soft-tissue sarcoma patient follow-up. Literature has yet to reflect the consensus these guidelines suggest and he stresses the need for clinical trials to identify an optimal surveillance strategy, one balancing gains in survival, quality of life, costs, and societal willingness to expend resources .
A prospective randomized controlled trial to evaluate the effectiveness of follow up strategies and their role in influencing overall survival could help in outlining a rational, accurate, easily applicable, cost effective surveillance regime.
- Conditions
- Sarcomas
- Keywords
- bone tumor, soft tissue tumor, cancer
- Medical subject headings
- Sarcoma, Bone Neoplasms, Soft Tissue Neoplasms, 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 |
|---|---|---|
| I A | INTENSIVE 3 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at three-month follow-up A CT scan of the chest was done on a six-monthly basis. CXR at the intervening three-month follow-up. | |
| I B | INTENSIVE 6 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at six month follow-up A CT scan of the chest was done on a six-monthly basis | |
| II A | COST EFFECTIVE 3 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at three-month follow-up with CXR | |
| II B | COST EFFECTIVE 6 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at six month follow-up with CXR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Patient survival
Measured: 10 years
Secondary outcomes (1)
Disease free survival
Local or distant recurrence
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study startJan 2006
- Primary completionJun 2010
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcomasStudies 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
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- Terry Fox Foundation
- Responsible party
- Principal investigator, Ajay Puri, Tata Memorial Hospital
- Investigators
- Dr AJAY PURI, ORTHOPAEDIC ONCOLOGIST, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827458
- Sponsor's protocol ID
- TMH BST-216
- Acronym
- TOSS
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2013
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cipriano CA, Jang E, Tyler W. Sarcoma Surveillance: A Review of Current Evidence and Guidelines. J Am Acad Orthop Surg. 2020 Feb 15;28(4):145-156. doi: 10.5435/JAAOS-D-19-00002.
PubMed 31651565Chiesa AM, Spinnato P, Miceli M, Facchini G. Radiologic Assessment of Osteosarcoma Lung Metastases: State of the Art and Recent Advances. Cells. 2021 Mar 4;10(3):553. doi: 10.3390/cells10030553.
PubMed 33806513Heinemann M, Ranft A, Langer T, Jurgens H, Kreyer J, Vieth V, Schafers M, Weckesser M, Simon T, Hassenpflug W, Corbacioglu S, Bielack S, Mayer-Steinacker R, Kuhne T, van den Berg H, Gelderblom H, Bauer S, Stegger L, Dirksen U. Recurrence of Ewing sarcoma: Is detection by imaging follow-up protocol associated with survival advantage? Pediatr Blood Cancer. 2018 Jul;65(7):e27011. doi: 10.1002/pbc.27011. Epub 2018 Feb 26.
PubMed 29480574
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adequate Cost Effective Follow Up Protocol For Bone and Soft Tissue Sarcomas: - A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05827458
- Acronym / sponsor ID
- TOSS / TMH BST-216
- Conditions
- Sarcomas
- Keywords
- bone tumor, soft tissue tumor, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- Terry Fox Foundation
- Study start
- Jan 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Apr 2023 (actual)
- 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.
Bone and soft tissue sarcomas are rare tumors, accounting for approximately 1% of all adult malignancies. The majority of bone and soft tissue sarcomas occur in the extremities. After treatment of the primary tumor, 40 % to 60% of the patients will develop local or distant recurrent disease. The ultimate determinant of survival in patients with bone and soft tissue sarcomas is the development of distant metastasis. Modern multimodality therapy has improved patient survival; hence follow-up surveillance strategies are becoming increasingly important with significant clinical and fiscal implications. However, the ideal postoperative protocol vis a vis frequency and appropriate screening modalities for these uncommon neoplasms remains ill-defined. Although guidelines have been proposed for follow-up of patients , there is a paucity of data in medical literature on the effectiveness of these recommendations. A prospective randomized controlled trial to evaluate the effectiveness of follow up strategies in picking up disease recurrence and their role in influencing overall survival would go a long way in answering some of these questions.
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 bone and soft tissue 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.
This study 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 bone and soft tissue sarcomas . 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. Though it is well accepted that in bone and soft tissue sarcomas the majority of recurrences either local or distant would occur in the first two years there has been no study to gauge the effectiveness of an intensive three monthly follow up during this initial "risk" period in improving overall survival . We have therefore further attempted to stratify the patients in both arms into Group A and Group B. Compared to Group A patients, Group B patients would have two less follow up visits per year in the initial two years of follow up. This could help to further reduce both the cost and loss of working man hours in these patients.
Correlation between local failure and the development of metastatic disease remains controversial. Though Lewis et al have suggested that there is strong association of local recurrence with the development of subsequent metastasis and tumor mortality, various prospective randomized trials have failed to show that better local control improves survival.
Though an MRI is advantageous in the initial evaluation of STS its utility in the diagnosis of patients with recurrent lesions, including its comparison with physical examination alone has yet to be documented. Distortion of the anatomy and fibrosis because of prior surgery and radiotherapy makes interpretation of post operative images difficult. In a series of 150 patients from the Rosewall Park Cancer Institute almost all the local recurrences were detected on physical examination and 86% of these were deemed resectable .Does an MRI actually help in the accurate early detection of local recurrence and if so does this early detection and subsequent intervention impact on overall survival? Its use has to be assessed critically with regard to cost effectiveness and efficacy.
Patients with extremity bone and soft tissue sarcomas are more likely to have distant metastasis as their initial site of recurrence . Pulmonary metastasis comprises most of these distant failures. The benefit of detection of recurrence depends on the availability of therapeutic interventions that can prolong survival. The occurrence rate of isolated pulmonary metastasis is in the range of 20% to 40% and there is a potential to salvage these patients. Though Huth et al felt that the impact of resection of pulmonary metastasis on improving survival of patients with soft tissue sarcoma was minimal a retrospective study by Geel et al recommended surgical excision of lung metastasis in order to improve survival. CT scanning of the chest is known to be more sensitive than CXR in detecting lung lesions but its specificity in detecting metastatic lesions is lower. The role of CT scanning in the surveillance of metastatic disease is therefore not clear. Whooley et al do not recommend CT scanning of the chest as a surveillance technique because of the high accuracy of CXR in recurrence detection in their series .
There is enough evidence in literature from other solid tumor types i.e. breast cancer, colorectal cancer and melanoma that challenges the usefulness of multiple follow up imaging tests in terms of efficacy , cost effectiveness and survival benefit .Whether the same surmise holds true for extremity soft tissue sarcoma is a matter of debate. Kane states that for soft tissue sarcomas, patient education and follow up visits with thorough history and physical examination will detect the vast majority of recurrent disease . Goel in his article on "Costs of follow-up after potentially curative treatment for extremity soft-tissue sarcoma" states that several guidelines have been proposed for extremity soft-tissue sarcoma patient follow-up. Literature has yet to reflect the consensus these guidelines suggest and he stresses the need for clinical trials to identify an optimal surveillance strategy, one balancing gains in survival, quality of life, costs, and societal willingness to expend resources .
A prospective randomized controlled trial to evaluate the effectiveness of follow up strategies and their role in influencing overall survival could help in outlining a rational, accurate, easily applicable, cost effective surveillance regime.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I A | – | –INTENSIVE 3 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at three-month follow-up A CT scan of the chest was done on a six-monthly basis. CXR at the intervening three-month follow-up. |
| I B | – | –INTENSIVE 6 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at six month follow-up A CT scan of the chest was done on a six-monthly basis |
| II A | – | –COST EFFECTIVE 3 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at three-month follow-up with CXR |
| II B | – | –COST EFFECTIVE 6 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at six month follow-up with CXR |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 PATIENTS OVERALL. 250 PATIENTS ON INTENSIVE GROUP 250 PATIENTS ON COST EFFECTIVE GROUP
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: 10 years
Patient survival
1 secondary outcome
Disease free survival
Time frame: 10 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 25 Apr 2023.
- Background: PubMed 31651565Cipriano CA, Jang E, Tyler W. Sarcoma Surveillance: A Review of Current Evidence and Guidelines. J Am Acad Orthop Surg. 2020 Feb 15;28(4):145-156. doi: 10.5435/JAAOS-D-19-00002.
- Background: PubMed 33806513Chiesa AM, Spinnato P, Miceli M, Facchini G. Radiologic Assessment of Osteosarcoma Lung Metastases: State of the Art and Recent Advances. Cells. 2021 Mar 4;10(3):553. doi: 10.3390/cells10030553.
- Background: PubMed 29480574Heinemann M, Ranft A, Langer T, Jurgens H, Kreyer J, Vieth V, Schafers M, Weckesser M, Simon T, Hassenpflug W, Corbacioglu S, Bielack S, Mayer-Steinacker R, Kuhne T, van den Berg H, Gelderblom H, Bauer S, Stegger L, Dirksen U. Recurrence of Ewing sarcoma: Is detection by imaging follow-up protocol associated with survival advantage? Pediatr Blood Cancer. 2018 Jul;65(7):e27011. doi: 10.1002/pbc.27011. Epub 2018 Feb 26.
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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, ORTHOPAEDIC ONCOLOGIST 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 Sarcomas, 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 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 25 Apr 2023. 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: 10 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 NCT05827458, which also lists 3 linked publications.
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 25 Apr 2023.