Solid TumorATOM-1stNCT07545486
Ablative Therapy of Oligometastatic Tumor After Response to Conventional First Line Treatment
An observational study of Solid Tumor, run by Chirec at 12 sites in 5 countries.
Trial summary
Advancements in systemic antineoplastic therapies have led to improved overall survival rates for many solid tumors. However, metastatic disease remains a significant challenge and remains the leading cause of mortality for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Data extraction from medical files
- How many people
- 1,235 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 1 Jun 2026to 1 Jun 2036
- Phase
- Observational
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
Study population: Patients with non-progressive disease after at least 3 months of optimal standard first line therapy (OST) defined according to ESMO guidelines. The OST is defined as the up-to-date most efficient first systemic line in term of anti-tumoral activity and survival benefit for each tumor type according to the ESMO guidelines and national practice. All cancer sites (including primitive lesion if concerned) must be accessible for local ablative treatment (LAT) based on radiological assessment of less than 6 weeks and LAT must have been decided by the investigator's local multidisciplinary team before inclusion in the study.
Who may be able to join
- Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG).
- Histologically diagnosis of one of these tumour types:
- Hormone receptor positive, HER2 negative breast cancer
- Triple negative breast cancer
- HER2+ breast cancer
- Non small cell lung cancer without oncogenic addiction
Show all 24Show fewer
- Head and Neck squamous cell carcinoma without recurrence in the radiation field
- Gastric adenocarcinoma
- Esophageal cancer (adenocarcinoma or epidermoid carcinoma)
- Recurrent pancreatic cancer without local recurrence
- Anal cancer
- Bladder cancer
- Clear cells renal cell carcinoma
- Prostate cancer sensitive to castration
- Adenocarcinoma endometrial cancer
- Epidermoid carcinoma or adenocarcinoma of the cervix
- Colorectal cancer
- Recurrent Soft Tissue Sarcoma
- Melanoma
- Patient with a decision by the local team to give OST and effective administration of OST. OST is defined as the most efficient choice in terms of survival in first line of advanced disease according to ESMO or other international guidelines. In case of multiple choice as first line, if no data provided direct evidence of superiority from one or the other options, there are all considered as OST. If the patient received a less efficient treatment because of his comorbidity or frailty, the eligible criteria won't be fulfilled.
- Have non-progressive disease after 3 to 6 months of treatment, and less than 6 weeks before presentation to the multidisciplinary team
- Patients with complete response and no target lesion are excluded.
- Patients with bone metastasis with remaining bone condensation or scare from tumoral activity may be eligible depending on metabolic activity of the lesion or local multidisciplinary committee decision concerning the risk of residual disease.
- After 3 to 6 months of treatment, and less than 6 weeks before start of LAT, patient must have an oligometastatic disease defined as all lesions (including primitive lesion) amenable to local ablative treatment according to local investigator team and respective local committee.
Who cannot join
- Patients who already received systemic antitumoral treatment in the advanced setting (including chemotherapy, immunotherapy, targeted therapy, …)
- Patients without OST administration
- Patients that have progressing lesion at any time point before decision of LAT by the expert committee
- Has a known recent history of other invasive tumour, excepted if local investigator may provide histologically data that all active lesions targeted are from the same cancer primitive.
- Radiotherapy or other LAT to any metastatic site before the start of OST.
- Exclusion criteria specific for France: Vulnerable persons according to the article L.1121-6 of the public health law (CSP), adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the CSP
Trial locations and contacts
12 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 5 countries
Belgium5 sites
CHU Brugmann
Brussels, 1020
Peter VUYLSTEKE, MD, 3224772158, peter.vuylsteke@chu-brugmann.be
Marianne Paesmans, 3224773306, marianne.paesmans@chu-brugmann.be
CHIREC Hospital
Brussels, 1160
Ahmad Awada, MD, +32 2 434 52 11, Ahmad.Awada.Onco@chirec.be
Ahmad Awada, MD
Cliniques Universitaires Saint-Luc
Brussels, 1200
François DUHOUX, MD, +3227645435, francois.duhoux@saintluc.uclouvain.be
Jean Pascal MACHIELS, + 32 2 764 19 92, jean-pascal.machiels@saintluc.uclouvain.be
Grand Hôpital de Charleroi, site Notre Dame
Charleroi, 6000
Jean-Luc Canon, +32 60 11 12 24, jean-luc.canon@ghdc.be
David Schroeder, +32 60 11 12 25, david.schroeder@ghdc.be
HELORA Hôpital de Mons - Site Kennedy
Mons, 7000
Stéphane Holbrechts, MD, +32 65 41 37 46, stephane.holbrechts@helora.be
Stéphane Holbrechts, MD
France4 sites
Centre de Lutte contre le Cancer François Baclesse
Caen, 14000
François CHERIFI, MD
François CHERIFI, MD
Institut Paoli-Calmettes
Marseille, 13009
Anthony GONCALVES, MD
Anthony GONCALVES, MD
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Simon NANNINI, MD
Simon NANNINI, MD
Hôpital Universitaire de Strasbourg
Strasbourg, 67200
Philippe BARTHELEMY, MD
Philippe BARTHELEMY, MD
Cyprus1 site
Bank of Cyprus Oncology
Nicosia, 2006
Demetris PAPAMICHAEL, MD
Demetris PAPAMICHAEL, MD
Lebanon1 site
American University of Beirut (AUB)
Beirut
Ali SHAMSEDDINE, MD
Ali SHAMSEDDINE, MD
Norway1 site
Oslo University Hospital / The Norwegian Radium Hospital
Oslo
Jon AMUND KYTE, jonky@ous-hf.no
Jon AMUND KYTE, MD
About this study
Advancements in systemic antineoplastic therapies have led to improved overall survival rates for many solid tumors. However, metastatic disease remains a significant challenge and remains the leading cause of mortality for these patients. Additionally, there is a high attrition rate after first-line standard treatment across various tumor types, with studies indicating that 20-70% of patients may be unable to undergo second-line therapy, depending on the tumor type.
This highlights an urgent need to enhance outcomes from the first line of treatment. Although first-line therapy often represents the best available option, most patients experience relapse and disease progression despite an initial tumor response. This is attributed to both intrinsic and acquired resistance arising from the heterogeneity of primary tumors and metastases. To address this issue, metastasis-directed therapy (MDT) has been explored as a way to reduce tumor burden and mitigate the risk of resistance due to therapeutic selective pressure.
Read more
MDT offers a promising opportunity to improve first-line treatment outcomes, but more precise patient selection criteria are needed to maximize therapeutic benefit and minimize the potential toxicity of ablative therapies. Indeed, despites its efficacy, fatal complication may occur so do grade 3 to 4 toxicities. Toxicity depends of the local ablative therapy (LAT) planned but as it will never be none, oncologists have to propose invasive treatment to patient that may benefit the most.
Based on the published data, the investigators propose a pragmatic, selective approach centered on sensitivity to systemic therapy. The investigators aim to evaluate the benefit of local ablative therapy (LAT) in patients who demonstrate non-progressive disease after three months of first-line standard of care. Given the importance of this question across cancer subtypes, the investigators will employ a prospective database to enroll patients with various solid tumor type, excluding the ones for which the impact of LAT has already been explored or may be difficult to achieve. Outcomes of this strategy will be evaluated compared to outcomes from pivotal studies defining optimal standard first line therapy (OST) .
Several analyses will be performed to better characterize the population for whom a multimodal approach may significantly improve their survival. The first one will aim to compare the median duration of response (mDOR) of the population treated with LAT compared to the mDOR reported by the pivotal study(ies) of each OST.
This study will serve as a proof of concept, supporting chemosensitivity as a viable selection factor for multimodal treatment in a broad range of cancer types.
Primary objective:
Improvement of the duration of response (DOR) after completion of LAT compared to DOR reported in pivotal study that evaluated first line OST.
Secondary objectives:
- Evaluation of the safety of the addition of LAT.
- Evaluation of overall progression free survival (PFS) and PFS at 1 year.
- Evaluation of overall survival from OST start and from the time of LAT completion.
- Documentation of acceptance and compliance to LAT decision by the institutional expert committee
- Conditions
- Solid Tumor
- Being tested
- Data extraction from medical files
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| HR+ HER2- breast cancer | Hormone receptor positive, HER2 negative breast cancer treated by CDK4/6 inhibitor and endocrine therapy Receives: Other: Data extraction from medical files | |
| Triple negative breast cancer | Triple negative breast cancer treated by association of pembrolizumab and chemotherapy or standard first line chemotherapy (paclitaxel, epirubicin +/- cyclophosphamide, carboplatine + gemcitabine). Receives: Other: Data extraction from medical files | |
| HER2+ breast cancer | HER2 positive breast cancer treated by dual blockade HER2 and taxane Receives: Other: Data extraction from medical files | |
| NSCLC | Non-small cell lung cancer (NSCLC) without usual oncogenic addiction treated by chemotherapy and immunotherapy or immunotherapy alone if indicated. Receives: Other: Data extraction from medical files | |
| Gastric adenocarcinoma | Gastric adenocarcinoma without local recurrence and treated by 5FU-based chemotherapy combined with immune checkpoint inhibitor (ICI) and/or Trastuzumab if indicated Receives: Other: Data extraction from medical files | |
| Oesophageal cancer | Oesophageal cancer without local recurrence treated by 5FU-based chemotherapy +/- ICI Receives: Other: Data extraction from medical files | |
| Pancreatic cancer | Pancreatic cancer without local recurrence treated by FOLFIRINOX or Gemcitabine + Nab-Paclitaxel Receives: Other: Data extraction from medical files | |
| Anal cancer | Anal cancer treated by carboplatin + paclitaxel or modified DCF Receives: Other: Data extraction from medical files | |
| Bladder cancer | Bladder cancer treated by platin based chemotherapy or Enfortumab Vedotin + Pembrolizumab Receives: Other: Data extraction from medical files | |
| Prostate cancer | Metastatic prostate cancer sensitive to castration treated by first and second generation of hormonotherapy Receives: Other: Data extraction from medical files | |
| Renal cell carcinoma | Renal cell carcinoma treated by ICI combined with ICI or tyrosine kinase inhibitor of VEGFR Receives: Other: Data extraction from medical files | |
| Endometrial cancer | Endometrial cancer treated by carboplatin + paclitaxel + dostarlimab Receives: Other: Data extraction from medical files | |
| Cervical cancer | Cervical cancer treated by platin + paclitaxel + bevacizumab + pembrolizumab Receives: Other: Data extraction from medical files | |
| HNSCC | Head and neck squamous cells carcinoma (HNSCC) without recurrence in the radiation field, treated by chemotherapy and immunotherapy or immunotherapy alone Receives: Other: Data extraction from medical files | |
| Colorectal cancer | Colorectal cancer treated by 5FU based chemotherapy and targeted therapy (bevacizumab or cetuximab or panitumumab) Receives: Other: Data extraction from medical files | |
| Soft tissue sarcomas | Soft tissue sarcomas already locally operated and treated by doxorubicin alone every three weeks or in association with ifosfamide or trabectedin. Receives: Other: Data extraction from medical files | |
| Melanoma | Melanoma treated by ICI or by BRAF/MEK inhibitors Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of response after completion of LAT (DORLAT)
DORLAT is defined by the time between end of local ablative therapy and disease progression (according to RECIST 1.1 criteria) or death, depending of which happen first.
Measured: From end of local ablative therapy to disease progression or death, depending of which happen first and up to 5 years.
Secondary outcomes (4)
Adverse event count
Clinical and laboratory adverse events (AEs) and serious adverse events (SAEs) will be reported and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: From the time of LAT decision to up to 6 months after LAT and subsequent OST administration
Overall Survival OST
Overall Survival defined by the time between OST start and death of the patient
Measured: From OST start to death of the patient and up to 5 years
Overall Survival LAT
Overall Survival is defined by the time between LAT completion and death of the patient
Measured: From LAT completion to death of the patient and up to 5 years
Progression free survival
Progression free survival is defined by the time between OST start and first disease progression
Measured: From OST start to first disease progression and up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2033 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 1,235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chirec
- Sponsor type
- University, hospital or other
- Collaborators
- CHU Brugmann, Brussels, Oncodistinct
- Responsible party
- Principal investigator, Dr Ahmad Awada, Chirec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545486
- Sponsor's protocol ID
- ATOM-1st
- Acronym
- ATOM-1st
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided