Rectal Cancer StagePETNECNCT04564482
PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer
A study testing CRT, SCPRT and CROSS Protocol in people with Rectal Cancer Stage and Oesophageal Cancer, run by Johannes Laengle, MD, PhD at 1 site in Austria.
Trial summary
The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rectal Cancer Stage, Oesophageal Cancer
- What is being tested?
- CRT, SCPRT and CROSS Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2022to 1 Jun 2026
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- All sexes
- Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)
- Medical need for a neoadjuvant CRT/SCPRT
- Suitable to withstand the course of neoadjuvant CRT/SCPRT
- Written informed consent form (ICF) for participation in the study
Who cannot join
- Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)
- Previous surgery of the tumor other than biopsy
- Pregnancy, breastfeeding or expectancy to conceive
- Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy
- Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
- Hepatitis B or C
Show all 19Show fewer
- Human immunodeficiency virus (HIV)
- Immunodeficiency
- Allogeneic tissue or solid organ transplantation
- Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs
- Active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers
- Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment
- Participants with serious or uncontrolled medical disorders
- Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males > 450 ms and > 470 ms in females, participants with history of myocarditis)
- Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)
- Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Johannes Laengle, MD, PhD, +43 1 40400 69260, johannes.laengle@meduniwien.ac.at
Michale Bergmann, MD, +43 1 40400 69260, michael.bergmann@meduniwien.ac.at
About this study
Official title: Programmed Death-ligand 1 Positron Emission Tomography Imaging During Neoadjuvant (Chemo)radiothErapy in Esophageal and Rectal Cancer (PETNEC): a Prospective Non-randomized Open-label Single-center Pilot Study
The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach.
- Conditions
- Rectal Cancer Stage, Oesophageal Cancer
- Being tested
- CRT, SCPRT, CROSS Protocol, PD-L1 PET
- Keywords
- Rectal Cancer, Oesophageal Cancer, Chemoradiotherapy, Short-course preoperative radiotherapy, PD-L1 PET, 89Zr-atezolizumab
- Medical subject headings
- Esophageal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTRadiation
50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO
SCPRTRadiation
25 Gy in 5 Gy fractions over 5 working days
CROSS ProtocolRadiation
41.4 Gy in 1.8 Gy fractions over 23 working days + carboplatin AUC of 2 mg/ml/min + paclitaxel 50 mg/m2 IV Q1W
PD-L1 PETDiagnostic test
10 mg atezolizumab IV followed by 37 MBq 89Zr-atezolizumab IV. PET imaging will be done before neoadjuvant CRT/SCPRT (day 0) and between day 10-14 during CRT/SCPRT.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoradiotherapy (CRT) | Other | Not described Receives: Radiation: CRT; Diagnostic Test: PD-L1 PET |
| Short-course preoperative radiotherapy (SCPRT) | Other | Not described Receives: Radiation: SCPRT; Diagnostic Test: PD-L1 PET |
| Neoadjuvant Chemoradiotherapy (CROSS protocol) | Other | Not described Receives: Radiation: CROSS Protocol; Diagnostic Test: PD-L1 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT
Intratumoral PD-L1 expression dynamics induced by neoadjuvant CRT/SCPRT will be assessed by 89Zr-atezolizumab PET imaging (day 0 and between day 10-14).
Measured: 3 weeks
Secondary outcomes (2)
Radiographic therapy response
Radiographic therapy response will be determined by magnetic resonance imaging-assessed tumor regression grade (mrTRG) for rectal cancer and PET response criteria in solid tumors (PERCIST) for esophageal cancer.
Measured: 12 weeks
Pathological therapy response
Pathological therapy response will be determined according to the latest American Joint Committee on Cancer/International Union Against Cancer-Tumor Node Metastasis (AJCC/UICC-TNM) staging and tumor regression grade (TRG).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Nov 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer StageStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Laengle, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johannes Laengle, MD, PhD, Medical University of Vienna
- Investigators
- Alexander Haug, MD, Principal investigator, Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564482
- Sponsor's protocol ID
- PETNEC
- Other IDs
- 2020-003142-37
- Acronym
- PETNEC
- Status last verified
- Mar 2024
- First submitted
- 15 Sep 2020
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Death-ligand 1 Positron Emission Tomography Imaging During Neoadjuvant (Chemo)radiothErapy in Esophageal and Rectal Cancer (PETNEC): a Prospective Non-randomized Open-label Single-center Pilot Study
- ClinicalTrials.gov ID
- NCT04564482
- Acronym / sponsor ID
- PETNEC / PETNEC
- Conditions
- Rectal Cancer Stage, Oesophageal Cancer
- Keywords
- Rectal Cancer, Oesophageal Cancer, Chemoradiotherapy, Short-course preoperative radiotherapy, PD-L1 PET, 89Zr-atezolizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johannes Laengle, MD, PhDUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Sep 2020 (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.
The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoradiotherapy (CRT) | Other | Radiation: CRT, Diagnostic Test: PD-L1 PET |
| Short-course preoperative radiotherapy (SCPRT) | Other | Radiation: SCPRT, Diagnostic Test: PD-L1 PET |
| Neoadjuvant Chemoradiotherapy (CROSS protocol) | Other | Radiation: CROSS Protocol, Diagnostic Test: PD-L1 PET |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and older
- All sexes
- Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)
- Medical need for a neoadjuvant CRT/SCPRT
- Suitable to withstand the course of neoadjuvant CRT/SCPRT
Key exclusion criteria (19 listed)
- Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)
- Previous surgery of the tumor other than biopsy
- Pregnancy, breastfeeding or expectancy to conceive
- Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy
- Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
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 |
|---|---|---|
| CRT50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO | Radiation | Neoadjuvant Chemoradiotherapy (CRT) |
| SCPRT25 Gy in 5 Gy fractions over 5 working days | Radiation | Short-course preoperative radiotherapy (SCPRT) |
| CROSS Protocol41.4 Gy in 1.8 Gy fractions over 23 working days + carboplatin AUC of 2 mg/ml/min + paclitaxel 50 mg/m2 IV Q1W | Radiation | Neoadjuvant Chemoradiotherapy (CROSS protocol) |
| PD-L1 PET10 mg atezolizumab IV followed by 37 MBq 89Zr-atezolizumab IV. PET imaging will be done before neoadjuvant CRT/SCPRT (day 0) and between day 10-14 during CRT/SCPRT. | Diagnostic test | Neoadjuvant Chemoradiotherapy (CROSS protocol), Neoadjuvant Chemoradiotherapy (CRT), Short-course preoperative radiotherapy (SCPRT) |
Primary outcome
Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT
Time frame: 3 weeks
Intratumoral PD-L1 expression dynamics induced by neoadjuvant CRT/SCPRT will be assessed by 89Zr-atezolizumab PET imaging (day 0 and between day 10-14).
2 secondary outcomes
Radiographic therapy response
Time frame: 12 weeks
Pathological therapy response
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 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.
Alexander Haug, MD principal investigator
Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT, SCPRT and CROSS Protocol in people with Rectal Cancer Stage and Oesophageal Cancer, run by Johannes Laengle, MD, PhD at 1 site in Austria.
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 6 inclusion and 19 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 15 Mar 2024. 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 Austria. 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?
Contact Johannes Laengle, MD, PhD (+43140400 69260, johannes.laengle@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT (time frame: 3 weeks). 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 15 Mar 2024.