Soft-tissue SarcomaPhase 1RADIOSARPNCT02787642
A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma
A Phase 1 study testing Olaparib and Concomitant Radiotherapy in people with Soft-tissue Sarcoma, run by Institut Bergonié at 4 sites in France.
Trial summary
A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft-tissue Sarcoma
- What is being tested?
- Olaparib and Concomitant Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2016to May 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histology: patients with soft-tissue sarcoma histologically confirmed by central review (Pr Coindre team), except if the diagnosis was already confirmed by the RRePS Network,
- Upper/Lower limb or trunk wall soft-tissue sarcoma,
- Age ≥ 18 years,
- Locally advanced or locally recurrent primitive tumor, outside any previously irradiated field. Patients presenting operable locally Advanced or lacally recurrent tumor can be included. Patients with metastases can be included.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2,
- Life expectancy ≥ 6 months,
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- At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements,
- Adequate hematological, renal, metabolic and hepatic function:
- Haemoglobin ≥ 9 g/dL and no blood transfusions in the 14 days prior to study entry
- Absolute neutrophil count (ANc) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Total bilirubin ≤ 1.5 x upper limit of normality (ULN),
- Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≤ 2.5 x ULN,
- Serum creatinine ≤ 150 μmol/L or creatinine clearance ≥ 50 mL/min (according to local institution) in case of serum creatinine > 150 μmol/L,
- TP, INR ≤ 1.5 x ULN
- Women of childbearing potential must have a negative serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Female patients of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 1 month after last dose of study drug. Males patients, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 3 month after last dose of study drug. Acceptable birth control methods are described in appendix 10.
- Subjects of non-childbearing potential are those who have:
- Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
- LH and FSH levels in the post menopausal range for women under 50,
- radiation-induced oophorectomy with last menses >1 year ago,
- chemotherapy-induced menopause with >1 year interval since last menses,
- or surgical sterilisation (bilateral oophorectomy or hysterectomy).
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up,
- Voluntary signed and dated written informed consent prior to any specific procedure,
- Patients with a social security in compliance with the Law.
Who cannot join
- Any previous treatment with a PARP inhibitor, including Olaparib,
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication,
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy,
- Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids,
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent,
- Patients with uncontrolled seizures,
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- Men or women of childbearing potential who are not using an effective method of contraception as previously describes; women who are pregnant or breast feeding,
- No prior or concurrent malignant disease diagnosed or treated in the last 2 years, except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
- Patients receiving any systemic chemotherapy within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used),
- Concomitant use of known CYP3A4 inhibitors such as ketokonazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir,
- Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome,
- Blood transfusions within 14 days prior to study start,
- Patients with myelodysplastic syndrome/acute myeloid leukaemia,
- Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery,
- Participation to a study involving a medical or therapeutic intervention in the last 30 days,
- Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,
- Previous enrollment in the present study,
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- Patients who not have recovered from any effects of any major surgery
- Individuals deprived of liberty or placed Under legal guardianship
- Patients who have tumor in contact with, invading or encasing for more than 50% any major blood vessels
Trial locations and contacts
4 sites in 1 country.
France4 sites
Institut Bergonié
Bordeaux, 33076
Centre Léon Bérard
Lyon, 69373
Institut du Cancer de Montpellier
Montpellier, 34298
Institut Claudius Regaud - IUCT
Toulouse, 31052
About this study
Official title: A Phase Ib Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma
A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma.
Read the detailed description
This is a multicenter, prospective phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing four dose levels of Olaparib given with concomitant radiotherapy, followed by an expansion cohort.
- Conditions
- Soft-tissue Sarcoma
- Being tested
- Olaparib, Concomitant Radiotherapy
- Keywords
- Advanced soft-tissue sarcoma, Unresectable Soft-tissue Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Olaparib will be administered per os bidaily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression.
Concomitant RadiotherapyRadiation
Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8.
| Study group | Role | What they receive |
|---|---|---|
| Olaparib in association with concomitant radiotherapy | Experimental | Olaparib will be administered per os bi-daily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. Receives: Drug: Olaparib; Radiation: Concomitant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
We reported in the following the number of Participants who experienced DLT.
A DLT is defined as an adverse event (AE) or laboratory abnormality that fulfills all the criteria below: 1/ Occurs during the period of observation of DLTs defined as the period between the first day of treatment administration and up to 6 weeks after the end of radiotherapy. 2/ Is considered to be at least possibly related to the treatment strategy (radiotherapy or Olaparib).3/ Is unrelated to disease, disease progression, inter-current illness, or concomitant medications. 4/ Meets some criteria (see protocole), graded according to NCI CTCAEv4.0
Measured: Until to six weeks after end of radiotherapy
Maximum Tolerated Dose (MTD) of Olaparib in Association With Radiotherapy
MTD was determined by testing increasing doses up 150mg twice a day on dose escalation cohorts 1 to 4 with 3 to 11 participants each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) that could be related to treatment (reported in the following primary outcome measure).
Measured: Up to 6 weeks after end of radiotherapy for each dosing cohort
Secondary outcomes (6)
Percentage of Participants With Non-progression at 6 Months as Per RECIST 1.1
6-month non progression rate is defined as the proportion of complete (CR) or partial response (PR) at 6 months confirmed ≥ 4 weeks after initial documentation, or stable disease (SD) more than 24 weeks (RECIST v1.1, as determined by investigator review of tumor assessments).
Measured: up to 6-month after treatment onset
Percentage of Participants With Objective Responses at 6 Months as Per RECIST 1.1
6-month objective response, defined as CR or PR at 6 months confirmed ≥ 4 weeks after initial documentation, as determined by investigator review of tumor assessments using RECIST v1.1
Measured: up to 6-month after treatment onset
Best Response Under Treatment as Per RECIST 1.1
Best response under treatment is defined as the best response (CR, PR, SD) as per RECIST 1.1 recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria. It is determined once all the data for the patient is known.
Measured: End of treatment, approximately 13.5 weeks atfer treatment onset
Progression-free Survival (PFS) as Per RECIST 1.1
PFS is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first.
Measured: 1 year after treatment onset
Overall Survival (OS)
OS is defined as the time from study treatment initiation to death (of any cause).
Measured: 1 year after treatment onset
Musculoskeletal Tumor Society (MSTS) Functional Score
The Musculoskeletal Tumor Society (MSTS) score assesses functional outcomes before (week 2) and after (week 10) treatment with olaparib in combination with radiotherapy. It consists of six items (pain, function, emotional acceptance, and either support/walking/gait for lower limbs or positioning/dexterity/strength for upper limbs). Each item is rated 0-5, summed to a total score ranging from 0 (worst outcome) to 30 (best outcome). Higher scores represent better functional outcomes.
Measured: Two weeks after treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2021
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Soft-tissue 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787642
- Sponsor's protocol ID
- IB 2015-05
- Other IDs
- 2015-003722-13, 2015
- Acronym
- RADIOSARP
- Status last verified
- Feb 2026
- First submitted
- 2 May 2016
- Last updated
- 25 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sargos P, Sunyach MP, Ducassou A, Llacer C, Dinart D, Michot A, Valentin T, Firmin N, Blay JY, Gillon P, Bellera C, Italiano A. Results of a phase Ib study of olaparib with concomitant radiotherapy in soft-tissue sarcoma: a French sarcoma group study. Ann Oncol. 2025 May;36(5):592-600. doi: 10.1016/j.annonc.2025.01.016. Epub 2025 Jan 31.
PubMed 39894354Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
PubMed 32827353
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma
- ClinicalTrials.gov ID
- NCT02787642
- Acronym / sponsor ID
- RADIOSARP / IB 2015-05
- Conditions
- Soft-tissue Sarcoma
- Keywords
- Advanced soft-tissue sarcoma, Unresectable Soft-tissue Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 25 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma.
Detailed description
This is a multicenter, prospective phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing four dose levels of Olaparib given with concomitant radiotherapy, followed by an expansion cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olaparib in association with concomitant radiotherapy | Experimental | Drug: Olaparib, Radiation: Concomitant RadiotherapyOlaparib will be administered per os bi-daily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histology: patients with soft-tissue sarcoma histologically confirmed by central review (Pr Coindre team), except if the diagnosis was already confirmed by the RRePS Network,
- Upper/Lower limb or trunk wall soft-tissue sarcoma,
- Age ≥ 18 years,
- Locally advanced or locally recurrent primitive tumor, outside any previously irradiated field. Patients presenting operable locally Advanced or lacally recurrent tumor can be included. Patients with metastases can be included.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2,
Key exclusion criteria (21 listed)
- Any previous treatment with a PARP inhibitor, including Olaparib,
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication,
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy,
- Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids,
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent,
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 |
|---|---|---|
| OlaparibOlaparib will be administered per os bidaily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. | Drug | Olaparib in association with concomitant radiotherapy |
| Concomitant RadiotherapyRadiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. | Radiation | Olaparib in association with concomitant radiotherapy |
Primary outcome
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: Until to six weeks after end of radiotherapy
We reported in the following the number of Participants who experienced DLT. A DLT is defined as an adverse event (AE) or laboratory abnormality that fulfills all the criteria below: 1/ Occurs during the period of observation of DLTs defined as the period between the first day of treatment administration and up to 6 weeks after the end of radiotherapy. 2/ Is considered to be at least possibly related to the treatment strategy (radiotherapy or Olaparib).3/ Is unrelated to disease, disease progression, inter-current illness, or concomitant medications. 4/ Meets some criteria (see protocole), graded according to NCI CTCAEv4.0
Maximum Tolerated Dose (MTD) of Olaparib in Association With Radiotherapy
Time frame: Up to 6 weeks after end of radiotherapy for each dosing cohort
MTD was determined by testing increasing doses up 150mg twice a day on dose escalation cohorts 1 to 4 with 3 to 11 participants each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) that could be related to treatment (reported in the following primary outcome measure).
6 secondary outcomes
Percentage of Participants With Non-progression at 6 Months as Per RECIST 1.1
Time frame: up to 6-month after treatment onset
Percentage of Participants With Objective Responses at 6 Months as Per RECIST 1.1
Time frame: up to 6-month after treatment onset
Best Response Under Treatment as Per RECIST 1.1
Time frame: End of treatment, approximately 13.5 weeks atfer treatment onset
Progression-free Survival (PFS) as Per RECIST 1.1
Time frame: 1 year after treatment onset
Overall Survival (OS)
Time frame: 1 year after treatment onset
Musculoskeletal Tumor Society (MSTS) Functional Score
Time frame: Two weeks after treatment onset
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39894354Sargos P, Sunyach MP, Ducassou A, Llacer C, Dinart D, Michot A, Valentin T, Firmin N, Blay JY, Gillon P, Bellera C, Italiano A. Results of a phase Ib study of olaparib with concomitant radiotherapy in soft-tissue sarcoma: a French sarcoma group study. Ann Oncol. 2025 May;36(5):592-600. doi: 10.1016/j.annonc.2025.01.016. Epub 2025 Jan 31.
- Derived from this study: PubMed 32827353Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olaparib and Concomitant Radiotherapy in people with Soft-tissue Sarcoma, run by Institut Bergonié at 4 sites in France.
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 25 inclusion and 21 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (time frame: Until to six weeks after end of radiotherapy). The study lists 2 primary outcomes in all. 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 NCT02787642, which also lists 2 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 Feb 2026.