Rectal CancerARO 2024-13NCT06831981
Hyperthermia With Chemoradiotherapy in Rectal Cancer
A study testing Hyperthermia, Radiotherapy and Chemotherapy with 5-fluorouracil in people with Rectal Cancer, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Hyperthermia, Radiotherapy and Chemotherapy with 5-fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 2 sitesGermany
- Study dates
- 11 Sep 2024to 1 Mar 2037
- Phase
- Interventional
- 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
Who may be able to join
- Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0-12 cm from the anocutaneous line (i.e. lower and middle third of the rectum)
- Indication for total neoadjuvant therapy irrespective of participation in the current study.
- Any MRI staged rectal cancer with one of the following high-risk features:
- cT4
- cN2 (see Appendix)
- Distance to mesorectal fascia 1mm or less.
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- Involved Lateral pelvic lymph nodes
- EMVI (extramural venous invasion) positivity
- Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
- Aged at least 18 years. No upper age limit.
- WHO/ECOG Performance Status ≤ 1
- Adequate hematological, hepatic, renal and metabolic function parameters
- Informed consent of the patient
Who cannot join
- Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
- Tumors with microsatellite instability ("MSI-High Tumors") and the possibility for treatment with immune checkpoint inhibition.
- Contraindication for hyperthermia such as metal implants or pacemakers
- Distant metastases (to be excluded by CT scan of the thorax and abdomen)
- Preexisting fecal incontinence for solid stool
- Prior antineoplastic therapy for rectal cancer
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- Prior radiotherapy of the pelvic region
- Major surgery within the last 4 weeks prior to inclusion
- Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment
- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
- Other concomitant antineoplastic therapy
- Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder
- Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment
- Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free
- Known allergic reactions on study medication
- Known dihydropyrimidine dehydrogenase deficiency
- Psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital
Tübingen, Baden-Wurttemberg, 72076
Cihan Gani, MD, Prof. Dr., + 49 7071 82165, cihan.gani@med.uni-tuebingen.de
Barbara Gehler, MD, Dr., +49 7071 82165, barbara.gehler@med.uni-tuebingen.de
- Recruiting
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Cihan Gani, MD, Prof. Dr., +49 7071 29 82165, cihan.gani@med.uni-tuebingen.de
About this study
Official title: Radiochemotherapy With Concomitant Deep Regional Hyperthermia in Locally Advanced Rectal Cancer. A Prospective, Randomized Phase III Trial.
The goal of this clinical trial is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer.
Questions it aims to answer are:
Read more
- Can surgery be avoided if the tumor completely regresses?
- How high is the Local re-growth rate
- Is the treatment safe?
- Assessment of the Quality of life
- Rate of sphincter-sparing surgery
- Pathological staging, tumor downstaging
- Assessment of continence during the course of therapy
Participants will:
Undergo radiochemotherapy with or without addition of hyperthermia (50:50 randomisation) followed by standard consolidation chemotherapy. After treatment response evaluation surgery or non-operative management takes place.
Read the detailed description
In this prospective, randomized phase III trial "Radiochemotherapy with concomitant deep regional hyperthermia in locally advanced rectal cancer" trial it is hypothesized that with the addition of hyperthermia complete response rates can be further increased resulting in a higher number of patients who can omit surgery in favor of organ preservation and a surveillance protocol. Patients receive radiochemotherapy with 5-FU or capecitabine followed by standard consolidation chemotherapy with 5-FU/folinic acid/oxaliplatin or CAPOX. Hyperthermia will take place based on a 1:1 randomisation. After evaluation of treatment response in week 22 patients will either undergo surgical resection in case of residual tumor or non-operative management when a clinical complete response is seen or repeat evaluation after another 3 months in case of a near clinical complete response. In selected cases endoscopic procedures can be considered as an alternative to radical surgery.The primary objective of the study is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As the primary endpoint TME-free survival will be used (TMEFS).
- Conditions
- Rectal Cancer
- Being tested
- Hyperthermia, Radiotherapy, Chemotherapy with 5-fluorouracil, Consolidation chemotherapy with FOLFOX
- Keywords
- Hyperthermia, TME, high risk rectal tumors, locally advanced retal cancer, total neoadjuvant therapy, organ preservation
- Medical subject headings
- Rectal Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaOther
Additional hyperthermia to radiochemotherapy regime in Arm 1 and radiochemotherapy without additional hyperthermia in Arm 2.
RadiotherapyRadiation
Radiotherapy of the pelvis
Chemotherapy with 5-fluorouracilDrug
Chemotherapy with 5-flurouracil is given in parallel to radiotherapy
Consolidation chemotherapy with FOLFOXDrug
Consolidation chemotherapy with 5-fluorouracil and oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| Radiochemotherapy with hyperthermia followed by consolidation chemotherapy | Experimental | Radiochemotherapy with hyperthermia followed by consolidation chemotherapy. After restaging decision to watch and wait in case of complete or near complete response or surgery Receives: Other: Hyperthermia; Radiation: Radiotherapy; Drug: Chemotherapy with 5-fluorouracil; Drug: Consolidation chemotherapy with FOLFOX |
| Radiochemotherapy without hyperthermia followed by consolidation chemotherapy | Active comparator | Radiochemotherapy without hyperthermia followed by consolidation chemotherapy. After restaging decision to watch and wait in case of complete response or surgery Receives: Radiation: Radiotherapy; Drug: Chemotherapy with 5-fluorouracil; Drug: Consolidation chemotherapy with FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year TME-free survival (TMEFS)
The primary objective of the study is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As the primary endpoint two-year TME-free survival will be used (TMEFS).
Measured: From September 2024 until September 2036
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start11 Sep 2024
- Primary completion1 Jun 2036 (estimated)
- Study completion1 Mar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Radiochemotherapy of rectal cancer with (group 1) or without hyperthermia (group 2). Followed by consolidation chemotherapy (six courses). Option for 5x5 short time radiotherapy without hyperthermia followed by nine courses of consolidation chemotherapy.
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Erlangen, Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Cihan Gani, MD, Prof. Dr., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831981
- Sponsor's protocol ID
- 182/2024BO1
- Acronym
- ARO 2024-13
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiochemotherapy With Concomitant Deep Regional Hyperthermia in Locally Advanced Rectal Cancer. A Prospective, Randomized Phase III Trial.
- ClinicalTrials.gov ID
- NCT06831981
- Acronym / sponsor ID
- ARO 2024-13 / 182/2024BO1
- Conditions
- Rectal Cancer
- Keywords
- Hyperthermia, TME, high risk rectal tumors, locally advanced retal cancer, total neoadjuvant therapy, organ preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Erlangen, Charite University, Berlin, Germany
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 1 Jun 2036 (estimated)
- Study completion
- 1 Mar 2037 (estimated)
- First posted
- 18 Feb 2025 (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 goal of this clinical trial is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer.
Questions it aims to answer are:
- Can surgery be avoided if the tumor completely regresses?
- How high is the Local re-growth rate
- Is the treatment safe?
- Assessment of the Quality of life
- Rate of sphincter-sparing surgery
- Pathological staging, tumor downstaging
- Assessment of continence during the course of therapy
Participants will:
Undergo radiochemotherapy with or without addition of hyperthermia (50:50 randomisation) followed by standard consolidation chemotherapy. After treatment response evaluation surgery or non-operative management takes place.
Detailed description
In this prospective, randomized phase III trial "Radiochemotherapy with concomitant deep regional hyperthermia in locally advanced rectal cancer" trial it is hypothesized that with the addition of hyperthermia complete response rates can be further increased resulting in a higher number of patients who can omit surgery in favor of organ preservation and a surveillance protocol. Patients receive radiochemotherapy with 5-FU or capecitabine followed by standard consolidation chemotherapy with 5-FU/folinic acid/oxaliplatin or CAPOX. Hyperthermia will take place based on a 1:1 randomisation. After evaluation of treatment response in week 22 patients will either undergo surgical resection in case of residual tumor or non-operative management when a clinical complete response is seen or repeat evaluation after another 3 months in case of a near clinical complete response. In selected cases endoscopic procedures can be considered as an alternative to radical surgery.The primary objective of the study is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As the primary endpoint TME-free survival will be used (TMEFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Radiochemotherapy of rectal cancer with (group 1) or without hyperthermia (group 2). Followed by consolidation chemotherapy (six courses). Option for 5x5 short time radiotherapy without hyperthermia followed by nine courses of consolidation chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Radiochemotherapy with hyperthermia followed by consolidation chemotherapy | Experimental | Other: Hyperthermia, Radiation: Radiotherapy, Drug: Chemotherapy with 5-fluorouracil, Drug: Consolidation chemotherapy with FOLFOXRadiochemotherapy with hyperthermia followed by consolidation chemotherapy. After restaging decision to watch and wait in case of complete or near complete response or surgery |
| Radiochemotherapy without hyperthermia followed by consolidation chemotherapy | Active comparator | Radiation: Radiotherapy, Drug: Chemotherapy with 5-fluorouracil, Drug: Consolidation chemotherapy with FOLFOXRadiochemotherapy without hyperthermia followed by consolidation chemotherapy. After restaging decision to watch and wait in case of complete response or surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0-12 cm from the anocutaneous line (i.e. lower and middle third of the rectum)
- Indication for total neoadjuvant therapy irrespective of participation in the current study.
- Any MRI staged rectal cancer with one of the following high-risk features:
- Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
Key exclusion criteria (17 listed)
- Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
- Tumors with microsatellite instability ("MSI-High Tumors") and the possibility for treatment with immune checkpoint inhibition.
- Contraindication for hyperthermia such as metal implants or pacemakers
- Distant metastases (to be excluded by CT scan of the thorax and abdomen)
- Preexisting fecal incontinence for solid stool
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 |
|---|---|---|
| HyperthermiaAdditional hyperthermia to radiochemotherapy regime in Arm 1 and radiochemotherapy without additional hyperthermia in Arm 2. | Other | Radiochemotherapy with hyperthermia followed by consolidation chemotherapy |
| RadiotherapyRadiotherapy of the pelvis | Radiation | Radiochemotherapy with hyperthermia followed by consolidation chemotherapy, Radiochemotherapy without hyperthermia followed by consolidation chemotherapy |
| Chemotherapy with 5-fluorouracilChemotherapy with 5-flurouracil is given in parallel to radiotherapy | Drug | Radiochemotherapy with hyperthermia followed by consolidation chemotherapy, Radiochemotherapy without hyperthermia followed by consolidation chemotherapy |
| Consolidation chemotherapy with FOLFOXConsolidation chemotherapy with 5-fluorouracil and oxaliplatin | Drug | Radiochemotherapy with hyperthermia followed by consolidation chemotherapy, Radiochemotherapy without hyperthermia followed by consolidation chemotherapy |
Primary outcome
Two-year TME-free survival (TMEFS)
Time frame: From September 2024 until September 2036
The primary objective of the study is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As the primary endpoint two-year TME-free survival will be used (TMEFS).
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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Cihan Gani, MD, Prof. Dr. principal investigator
University Hospital Tuebingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia, Radiotherapy and Chemotherapy with 5-fluorouracil in people with Rectal Cancer, run by University Hospital Tuebingen at 2 sites 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 14 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Cihan Gani, MD, Prof. Dr. (+49 7071 29-82165, cihan.gani@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year TME-free survival (TMEFS) (time frame: From September 2024 until September 2036). 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 13 Oct 2026.