Locally Advanced Rectal CarcinomaPRIMONCT05524012
Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer
An observational study of Locally Advanced Rectal Carcinoma and Neoadjuvant Treatment, run by Jena University Hospital at 1 site in Germany.
Trial summary
This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Carcinoma, Neoadjuvant Treatment, Radiotherapy
- What is being tested?
- Blood sample and MRI scan
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 30 Nov 2022to 30 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 locally advanced rectal cancer (LARC), receiving neoadjuvant chemoradiotherapy (CRT).
Who may be able to join
- locally advanced rectal cancer (LARC): UICC Stage II/III
- no severe cardiac or lung disease
- no severe hepatic disorders (liver enzymes <2.5 NR) or restrictions of renal function (GFR > 30ml/min)
- no severe cytopenia (Neutrocytes >= 3 Gpt/l; Thrombocytes >= 100 Gpt/l; Hemoglobin >6mmol/l)
- no homozygotic DPD deficiency
- no other neoplasms requiring therapy
- no earlier radiotherapy of the pelvis or earlier chemotherapy
- no contraindications for MRI
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiotherapy and Radiation Oncology, Jena University Hospital
Jena
About this study
Official title: Planning Adaptive Treatment by Longitudinal Response Assessment Implementing MR Imaging, Liquid Biopsy and Analysis of Microenvironment During Neoadjuvant Treatment of Rectal Cancer (PRIMO)
This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model.
Read the detailed description
Patients with LARC, receiving neoadjuvant chemoradiotherapy (CRT) are followed by at least 4 multiparametric MRI-scans (diffusion weighted imaging and hypoxia-sensitive sequences) as well as repeated blood samples in order to analyse circulating tumour cells (CTCs). A standard pelvis radiotherapy (RT, 5040 cGy) will be performed in combination with a 5-Fluorouracil / Oxaliplatin regimen in all patients (planned: N = 50), succeeded by consolidation CTx (FOLFOX4) if feasible. Additional histologic markers, such as tumour-infiltrating lymphocytes (TILs) or PD-L1 status will be analysed before and after CRT. Resection is standard after completion of preoperative treatment. In case of complete regression and patient's request, a non-operative management ("watch and wait") is offered alternatively. The primary endpoint is response, defined by tumor regression grading, secondary endpoints comprise longitudinal changes in MRI as well as in CTCs and TILs.
- Conditions
- Locally Advanced Rectal Carcinoma, Neoadjuvant Treatment, Radiotherapy, Adaptive Treatment
- Being tested
- Blood sample, MRI scan
- Keywords
- total neoadjuvant therapy (TNT), T2* MRI, circulating tumor cells, tumor infiltrating lymphocytes, liquid biopsy, DWI, rectal cancer, organ preservation
- Medical subject headings
- Neoplastic Cells, Circulating, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Also called analyses of circulating tumor cells (CTC)
longitudinal blood samples for CTC monitoring
MRI scanDevice
Also called multiparametric (incl. DWI and T2* "BOLD")
longitudinal MRI scans (non-contrast enhanced)
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor regression grading (TRG)
Histological response assessment by TRG (Werner / Hoefler et al.); Complete response is defined as TRG 1a;
Measured: after completion of neoadjuvant treatment (up to 10 months)
Secondary outcomes (7)
MRI
longitudinal changes in multiparametric MRI sequences (diffusion weighted and hypoxia sensitive)
Measured: up to 10 months, until resection
Circulating Tumor Cells (CTC)
longitudinal changes in CTCs
Measured: 5 years
Tumor Infiltrating Lymphocytes (TIL)
longitudinal changes in TILs
Measured: up to 10 months, until resection
PFS
progression free survival
Measured: 5 years
OS
overall survival
Measured: 5 years
Surrogate marker: Interleukin 6 (IL-6)
surrogates of tumor and inflammation from routine blood draws [ng/l]
Measured: 5 years
Surrogate marker: Carcinoembryonic Antigen (CEA)
surrogates of tumor and inflammation from routine blood draws, [mg/l]
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start30 Nov 2022
- Primary completion31 Jan 2026
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CarcinomaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Wurschi, Jena University Hospital
- Investigators
- Andrea Wittig-Sauerwein, MD, Principal investigator, Department for Radiotherapy and Radiooncology, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524012
- Sponsor's protocol ID
- UKJ-PRIMO-2022
- Other IDs
- CSP-11, LIFE Talent Funds 2022
- Acronym
- PRIMO
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planning Adaptive Treatment by Longitudinal Response Assessment Implementing MR Imaging, Liquid Biopsy and Analysis of Microenvironment During Neoadjuvant Treatment of Rectal Cancer (PRIMO)
- ClinicalTrials.gov ID
- NCT05524012
- Acronym / sponsor ID
- PRIMO / UKJ-PRIMO-2022
- Conditions
- Locally Advanced Rectal Carcinoma, Neoadjuvant Treatment, Radiotherapy, Adaptive Treatment
- Keywords
- total neoadjuvant therapy (TNT), T2* MRI, circulating tumor cells, tumor infiltrating lymphocytes, liquid biopsy, DWI, rectal cancer, organ preservation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 1 Sep 2022 (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.
This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model.
Detailed description
Patients with LARC, receiving neoadjuvant chemoradiotherapy (CRT) are followed by at least 4 multiparametric MRI-scans (diffusion weighted imaging and hypoxia-sensitive sequences) as well as repeated blood samples in order to analyse circulating tumour cells (CTCs). A standard pelvis radiotherapy (RT, 5040 cGy) will be performed in combination with a 5-Fluorouracil / Oxaliplatin regimen in all patients (planned: N = 50), succeeded by consolidation CTx (FOLFOX4) if feasible. Additional histologic markers, such as tumour-infiltrating lymphocytes (TILs) or PD-L1 status will be analysed before and after CRT. Resection is standard after completion of preoperative treatment. In case of complete regression and patient's request, a non-operative management ("watch and wait") is offered alternatively. The primary endpoint is response, defined by tumor regression grading, secondary endpoints comprise longitudinal changes in MRI as well as in CTCs and TILs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced rectal cancer (LARC), receiving neoadjuvant chemoradiotherapy (CRT).
Key inclusion criteria (8 listed)
- locally advanced rectal cancer (LARC): UICC Stage II/III
- no severe cardiac or lung disease
- no severe hepatic disorders (liver enzymes <2.5 NR) or restrictions of renal function (GFR > 30ml/min)
- no severe cytopenia (Neutrocytes >= 3 Gpt/l; Thrombocytes >= 100 Gpt/l; Hemoglobin >6mmol/l)
- no homozygotic DPD deficiency
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood sampleAlso: analyses of circulating tumor cells (CTC)longitudinal blood samples for CTC monitoring | Diagnostic test | – |
| MRI scanAlso: multiparametric (incl. DWI and T2* "BOLD")longitudinal MRI scans (non-contrast enhanced) | Device | – |
Primary outcome
Tumor regression grading (TRG)
Time frame: after completion of neoadjuvant treatment (up to 10 months)
Histological response assessment by TRG (Werner / Hoefler et al.); Complete response is defined as TRG 1a;
7 secondary outcomes
MRI
Time frame: up to 10 months, until resection
Circulating Tumor Cells (CTC)
Time frame: 5 years
Tumor Infiltrating Lymphocytes (TIL)
Time frame: up to 10 months, until resection
PFS
Time frame: 5 years
OS
Time frame: 5 years
Surrogate marker: Interleukin 6 (IL-6)
Time frame: 5 years
Surrogate marker: Carcinoembryonic Antigen (CEA)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- 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.
Andrea Wittig-Sauerwein, MD principal investigator
Department for Radiotherapy and Radiooncology, Jena University 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 Locally Advanced Rectal Carcinoma and Neoadjuvant Treatment, run by Jena University Hospital 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 8 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Tumor regression grading (TRG) (time frame: after completion of neoadjuvant treatment (up to 10 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.