Retroperitoneal SarcomaNCT03792867
Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma
A study testing Doxorubicin in people with Retroperitoneal Sarcoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and affects many young people. In approximately 50% of patients, the tumour will reappear in the same area regardless of therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Retroperitoneal Sarcoma
- What is being tested?
- Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Jul 2018to 31 Mar 2024
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease Characteristics
- Histologically proven soft tissue sarcoma of one of following high-risk groups:
- Tumours with grade 2 or 3 histology
- Size more than or equal to 5cm
- Extracompartmental and deep extension
- Local recurrence of primary tumour
Show all 14Show fewer
- Inadequate surgical excision of previously operated on tumour
- Proven diagnosis of recurrent retroperitoneal sarcoma confirmed by imaging modality and/ or intraoperative biopsy
- Patient Characteristics
- Age: ≥21 years old
- Performance status: ECOG 0-1
- Normal haematological, hepatic, coagulation, renal and electrolyte profiles
- Normal left ventricular ejection fraction
- Not pregnant or nursing
Who cannot join
- Patient is medically unfit for surgery due to concurrent medical comorbidities.
- Any medical or psychiatric condition(s) which would preclude informed consent.
- Patient is pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma
Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and affects many young people. In approximately 50% of patients, the tumour will reappear in the same area regardless of therapy. Current treatment involves radical resection; however, it does not significantly reduce recurrence rates or improve overall survival. Recurrent retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded. One of the main challenges in the surgical treatment of this disease is the ability to accurately identify the local extension of the disease and to prevent local recurrence.
At present, there are no options to prevent recurrence after surgery. In recent years, there has been increased interest in the use of combined radical surgery with heated intraperitoneal chemotherapy (HIPEC). Radical resection is defined as en-bloc resection of the tumour including but not limited to surrounding organ resection and normal fat. This is in combination with the use of HIPEC. HIPEC is the use of chemotherapy in the intraperitoneal cavity that is heated to 40 to 42 degree Celsius.
Surgery coupled with HIPEC has shown to reduce recurrence in colorectal cancer, appendiceal cancer and mesothelioma. We hypothesize that HIPEC when coupled with radical surgery will improve the overall outcomes of patients with retroperitoneal sarcomatosis. We hope to learn if this treatment approach will increase locoregional control to reduce recurrence rates and improve survival.
- Conditions
- Retroperitoneal Sarcoma
- Being tested
- Doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.
| Study group | Role | What they receive |
|---|---|---|
| Radical Resection and HIPEC | Experimental | Not described Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment
Measured: From time of resection to one year post-surgery
Secondary outcomes (2)
Local recurrence-free survival
To determine if the introduction of radical surgery and HIPEC would improve the local recurrence-free survival of patients as compared to current treatment strategies
Measured: From time of resection until first occurrence of disease recurrence, up to 3 years
Overall survival
To determine if the introduction of radical surgery and HIPEC would improve the overall survival of patients as compared to current treatment strategies
Measured: From time of resection to death from any cause, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start23 Jul 2018
- Primary completion28 Feb 2022
- Study completion31 Mar 2024 (estimated)
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 Retroperitoneal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johnny Ong, MD, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792867
- Sponsor's protocol ID
- 2017/2012/B
- Status last verified
- Oct 2023
- First submitted
- 2 Jan 2019
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seo CJ, Tan JW, Farid M, Wong JSM, Soo KC, Chia CS, Ong CJ. Radical resection and hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of high risk recurrent retroperitoneal sarcoma-A pilot study in a tertiary Asian centre. PLoS One. 2024 Apr 4;19(4):e0300594. doi: 10.1371/journal.pone.0300594. eCollection 2024.
PubMed 38574044
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma
- ClinicalTrials.gov ID
- NCT03792867
- Acronym / sponsor ID
- 2017/2012/B
- Conditions
- Retroperitoneal Sarcoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 3 Jan 2019 (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.
Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and affects many young people. In approximately 50% of patients, the tumour will reappear in the same area regardless of therapy. Current treatment involves radical resection; however, it does not significantly reduce recurrence rates or improve overall survival. Recurrent retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded. One of the main challenges in the surgical treatment of this disease is the ability to accurately identify the local extension of the disease and to prevent local recurrence.
At present, there are no options to prevent recurrence after surgery. In recent years, there has been increased interest in the use of combined radical surgery with heated intraperitoneal chemotherapy (HIPEC). Radical resection is defined as en-bloc resection of the tumour including but not limited to surrounding organ resection and normal fat. This is in combination with the use of HIPEC. HIPEC is the use of chemotherapy in the intraperitoneal cavity that is heated to 40 to 42 degree Celsius.
Surgery coupled with HIPEC has shown to reduce recurrence in colorectal cancer, appendiceal cancer and mesothelioma. We hypothesize that HIPEC when coupled with radical surgery will improve the overall outcomes of patients with retroperitoneal sarcomatosis. We hope to learn if this treatment approach will increase locoregional control to reduce recurrence rates and improve survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical Resection and HIPEC | Experimental | Drug: Doxorubicin |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Disease Characteristics
- Patient Characteristics
Key exclusion criteria (3 listed)
- Patient is medically unfit for surgery due to concurrent medical comorbidities.
- Any medical or psychiatric condition(s) which would preclude informed consent.
- Patient is pregnant or nursing.
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 |
|---|---|---|
| DoxorubicinImmediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained. | Drug | Radical Resection and HIPEC |
Primary outcome
Incidence of treatment-related adverse events
Time frame: From time of resection to one year post-surgery
To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment
2 secondary outcomes
Local recurrence-free survival
Time frame: From time of resection until first occurrence of disease recurrence, up to 3 years
Overall survival
Time frame: From time of resection to death from any cause, up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 38574044Seo CJ, Tan JW, Farid M, Wong JSM, Soo KC, Chia CS, Ong CJ. Radical resection and hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of high risk recurrent retroperitoneal sarcoma-A pilot study in a tertiary Asian centre. PLoS One. 2024 Apr 4;19(4):e0300594. doi: 10.1371/journal.pone.0300594. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Johnny Ong, MD, PhD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxorubicin in people with Retroperitoneal Sarcoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 14 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: status not confirmed, as of the sponsor's last update on 11 Oct 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 Singapore. 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?
Results are not available in the source record.
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?
Incidence of treatment-related adverse events (time frame: From time of resection to one year post-surgery). 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 NCT03792867, 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 11 Oct 2023.