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New treatment option for Rectal Cancer
Official title Hyperthermia With Chemoradiotherapy in Rectal Cancer
ClinicalTrials.gov ID: NCT06831981
What this study is testing
What is Chemotherapy with 5-fluorouracil?
Chemotherapy with 5-fluorouracil is an investigational medicine, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0-12 cm from the anocutaneous line (i.e. lower and middle...
- 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:
- cN2 (see Appendix)
- Distance to mesorectal fascia 1mm or less.
You likely can't join if
- 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
See the full eligibility criteria
- 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:
- cN2 (see Appendix)
- Distance to mesorectal fascia 1mm or less.
- 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
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.