An interventional study of Hyperthermia and Radiotherapy in Rectal Cancer, sponsored by University Hospital Tuebingen. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment
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:
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.
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).
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 264 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Any MRI staged rectal cancer with one of the following high-risk features:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiochemotherapy with hyperthermia followed by consolidation chemotherapy. After restaging decision to watch and wait in case of complete or near complete response or surgery
Other: Hyperthermia · Radiation: Radiotherapy · Drug: Chemotherapy with 5-fluorouracil · Drug: Consolidation chemotherapy with FOLFOX
Radiochemotherapy without hyperthermia followed by consolidation chemotherapy. After restaging decision to watch and wait in case of complete response or surgery
Radiation: Radiotherapy · Drug: Chemotherapy with 5-fluorouracil · Drug: Consolidation chemotherapy with FOLFOX
Additional hyperthermia to radiochemotherapy regime in Arm 1 and radiochemotherapy without additional hyperthermia in Arm 2.
Radiotherapy of the pelvis
Drug page: Fluorouracil
Chemotherapy with 5-flurouracil is given in parallel to radiotherapy
Drug page: Folfox protocol
Consolidation chemotherapy with 5-fluorouracil and oxaliplatin
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).
Time frame: From September 2024 until September 2036
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jun 2036, 140 months after the start.
Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's planned 140 months is above that.
Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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