Retroperitoneal Soft Tissue SarcomaPhase 1/2NCT01566123
Trial of Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma (RETRO-WTS)
A Phase 1/2 study testing Neoadjuvant intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT) in people with Retroperitoneal Soft Tissue Sarcoma, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Soft Tissue Sarcoma
- What is being tested?
- Neoadjuvant intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Feb 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- histologically confirmed, primary or locally recurrent soft tissue sarcoma of the retroperitoneal space
- judged as at least marginally resectable
- absence of distant metastases
- tumor size ≥ 5 cm
Who cannot join
- missing written informed consent
- missing histological confirmation of soft tissue sarcoma
- Desmoid tumor (syn. aggressive fibromatosis)
- judged as gross incomplete or not resectable
- incomplete staging
- presence of distant metastases
Show all 9Show fewer
- prior radiation therapy to the abdominal region
- participation in another clinical interventional study
- inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Clinical Phase I/II Trial to Investigate Preoperative Dose-Escalated Intensity-Modulated Radiation Therapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients With Retroperitoneal Soft Tissue Sarcoma
Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. In contrast to extremity sarcoma, postoperative radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some centers to overcome these dose limitations and resulted in improved outcome, local failure rates are still high even if considerable treatment related toxicity is accepted. As postoperative administration of RT has some general disadvantages, neoadjuvant approaches could offer benefits in terms of dose escalation, target coverage and reduction of toxicity, especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT) are considered.
Therefore the RETROWTS trials has been designed as a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy) followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable RSTS. The primary objective is the local control rate after five years. Secondary endpoints are progression-free and overall survival, acute and late toxicity, surgical resectability and patterns of failure. The aim of accrual is 37 patients in the per-protocol population.
- Conditions
- Retroperitoneal Soft Tissue Sarcoma
- Being tested
- Neoadjuvant intensity-modulated radiation therapy (IMRT), intraoperative radiation therapy (IORT)
- Keywords
- retroperitoneal soft tissue sarcoma, IMRT, IORT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant intensity-modulated radiation therapy (IMRT)Radiation
neoadjuvant intensity-modulated radiation therapy, single dose 2.0-2.4 Gy, total dose 50-56 Gy
intraoperative radiation therapy (IORT)Radiation
during surgery, 10-12 Gy (90% isodose) to the tumor bed or residual disease
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma Receives: Radiation: Neoadjuvant intensity-modulated radiation therapy (IMRT); Radiation: intraoperative radiation therapy (IORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Rate
Measured: 5 year
Secondary outcomes (5)
Progression free survival
Measured: up to 5 years from first day of treatment
Overall Survival
Measured: up to five years from first day of treatment
Acute toxicity
scored according to CTCAE 3.0
Measured: up to 3 months from first day of treatment
Late Toxicity
scored according to CTCAE 3.0 and RTOG criteria
Measured: up to 5 years after first day of treatment
Severe acute gastrointestinal toxicity
severe defined as grade >= III, scored according to CTC AE 3.0
Measured: up to 3 months from first day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2007
- Primary completionJan 2020
- Study completionFeb 2020
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 Retroperitoneal Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Juergen Debus, M.D., Ph.D., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566123
- Sponsor's protocol ID
- RETROWTS
- Status last verified
- Apr 2020
- First submitted
- 20 Mar 2012
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seidensaal K, Dostal M, Kudak A, Jaekel C, Meixner E, Liermann J, Weykamp F, Hoegen P, Mechtersheimer G, Willis F, Schneider M, Debus J. Preoperative Dose-Escalated Intensity-Modulated Radiotherapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients with Retroperitoneal Soft-Tissue Sarcoma: Final Results of a Clinical Phase I/II Trial. Cancers (Basel). 2023 May 13;15(10):2747. doi: 10.3390/cancers15102747.
PubMed 37345084Roeder F, Ulrich A, Habl G, Uhl M, Saleh-Ebrahimi L, Huber PE, Schulz-Ertner D, Nikoghosyan AV, Alldinger I, Krempien R, Mechtersheimer G, Hensley FW, Debus J, Bischof M. Clinical phase I/II trial to investigate preoperative dose-escalated intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT) in patients with retroperitoneal soft tissue sarcoma: interim analysis. BMC Cancer. 2014 Aug 27;14:617. doi: 10.1186/1471-2407-14-617.
PubMed 25163595Roeder F, Schulz-Ertner D, Nikoghosyan AV, Huber PE, Edler L, Habl G, Krempien R, Oertel S, Saleh-Ebrahimi L, Hensley FW, Buechler MW, Debus J, Koch M, Weitz J, Bischof M. A clinical phase I/II trial to investigate preoperative dose-escalated intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT) in patients with retroperitoneal soft tissue sarcoma. BMC Cancer. 2012 Jul 12;12:287. doi: 10.1186/1471-2407-12-287.
PubMed 22788989
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phase I/II Trial to Investigate Preoperative Dose-Escalated Intensity-Modulated Radiation Therapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients With Retroperitoneal Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01566123
- Acronym / sponsor ID
- RETROWTS
- Conditions
- Retroperitoneal Soft Tissue Sarcoma
- Keywords
- retroperitoneal soft tissue sarcoma, IMRT, IORT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- Mar 2007 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 29 Mar 2012 (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.
Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. In contrast to extremity sarcoma, postoperative radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some centers to overcome these dose limitations and resulted in improved outcome, local failure rates are still high even if considerable treatment related toxicity is accepted. As postoperative administration of RT has some general disadvantages, neoadjuvant approaches could offer benefits in terms of dose escalation, target coverage and reduction of toxicity, especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT) are considered.
Therefore the RETROWTS trials has been designed as a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy) followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable RSTS. The primary objective is the local control rate after five years. Secondary endpoints are progression-free and overall survival, acute and late toxicity, surgical resectability and patterns of failure. The aim of accrual is 37 patients in the per-protocol population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Radiation: Neoadjuvant intensity-modulated radiation therapy (IMRT), Radiation: intraoperative radiation therapy (IORT)Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- written informed consent
- histologically confirmed, primary or locally recurrent soft tissue sarcoma of the retroperitoneal space
- judged as at least marginally resectable
- absence of distant metastases
- tumor size ≥ 5 cm
Key exclusion criteria (9 listed)
- missing written informed consent
- missing histological confirmation of soft tissue sarcoma
- Desmoid tumor (syn. aggressive fibromatosis)
- judged as gross incomplete or not resectable
- incomplete staging
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 |
|---|---|---|
| Neoadjuvant intensity-modulated radiation therapy (IMRT)neoadjuvant intensity-modulated radiation therapy, single dose 2.0-2.4 Gy, total dose 50-56 Gy | Radiation | A |
| intraoperative radiation therapy (IORT)during surgery, 10-12 Gy (90% isodose) to the tumor bed or residual disease | Radiation | A |
Primary outcome
Local Control Rate
Time frame: 5 year
5 secondary outcomes
Progression free survival
Time frame: up to 5 years from first day of treatment
Overall Survival
Time frame: up to five years from first day of treatment
Acute toxicity
Time frame: up to 3 months from first day of treatment
Late Toxicity
Time frame: up to 5 years after first day of treatment
Severe acute gastrointestinal toxicity
Time frame: up to 3 months from first day of treatment
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 3 Apr 2020.
- Derived from this study: PubMed 37345084Seidensaal K, Dostal M, Kudak A, Jaekel C, Meixner E, Liermann J, Weykamp F, Hoegen P, Mechtersheimer G, Willis F, Schneider M, Debus J. Preoperative Dose-Escalated Intensity-Modulated Radiotherapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients with Retroperitoneal Soft-Tissue Sarcoma: Final Results of a Clinical Phase I/II Trial. Cancers (Basel). 2023 May 13;15(10):2747. doi: 10.3390/cancers15102747.
- Derived from this study: PubMed 25163595Roeder F, Ulrich A, Habl G, Uhl M, Saleh-Ebrahimi L, Huber PE, Schulz-Ertner D, Nikoghosyan AV, Alldinger I, Krempien R, Mechtersheimer G, Hensley FW, Debus J, Bischof M. Clinical phase I/II trial to investigate preoperative dose-escalated intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT) in patients with retroperitoneal soft tissue sarcoma: interim analysis. BMC Cancer. 2014 Aug 27;14:617. doi: 10.1186/1471-2407-14-617.
- Derived from this study: PubMed 22788989Roeder F, Schulz-Ertner D, Nikoghosyan AV, Huber PE, Edler L, Habl G, Krempien R, Oertel S, Saleh-Ebrahimi L, Hensley FW, Buechler MW, Debus J, Koch M, Weitz J, Bischof M. A clinical phase I/II trial to investigate preoperative dose-escalated intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT) in patients with retroperitoneal soft tissue sarcoma. BMC Cancer. 2012 Jul 12;12:287. doi: 10.1186/1471-2407-12-287.
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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.
Juergen Debus, M.D., Ph.D. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neoadjuvant intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT) in people with Retroperitoneal Soft Tissue Sarcoma, run by University Hospital Heidelberg at 1 site in Germany.
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 5 inclusion and 9 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 3 Apr 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Local Control Rate (time frame: 5 year). 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 NCT01566123, 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 3 Apr 2020.