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New treatment option for Rectal Cancer
Official title Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy
ClinicalTrials.gov ID: NCT07337876
What this study is testing
- What it's testing
- This study is testing whether radiation delivered with MRI guidance using a so-called MR-linac in distal rectal cancer can result in a high rate of organ preservation. Patients will receive radiotherapy together with standard chemotherapy.
- Phase 2: a mid-size study of how well it works
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
- Patients with histologically confirmed diagnosis of rectal cancer localized between dentate line and 12 cm from the anocutaneous line
- Any MRI staged rectal cancer meeting the following criteria
- cT1-cT3 and
- cN0 -cN1 and
- Inclusion of UICC Stage I tumors only if unsuitable for endoscopic resection or if primary surgery would require permanent colostomy or deep...
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
- Distant metastases
- Preexisting fecal incontinence for solid stool
- Prior antineoplastic therapy for rectal cancer
- Prior radiotherapy of the pelvic region
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
See the full eligibility criteria
- Patients with histologically confirmed diagnosis of rectal cancer localized between dentate line and 12 cm from the anocutaneous line
- Any MRI staged rectal cancer meeting the following criteria
- cT1-cT3 and
- cN0 -cN1 and
- Inclusion of UICC Stage I tumors only if unsuitable for endoscopic resection or if primary surgery would require permanent colostomy or deep anastomosis with expected poor organ function.
- Tumor affects less than 70% of the rectal circumference.
- Maximum longitudinal extension of the tumor less than 8 cm on MRI
- MR-Staging requirements: High-resolution, thin-sliced (i.e. ≤3mm) magnetic resonance imaging (MRI) of the pelvis.
- 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
- Distant metastases
- Preexisting fecal incontinence for solid stool
- Prior antineoplastic therapy for rectal cancer
- Prior radiotherapy of the pelvic region
- Subject pregnant or breast feeding, 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
- Other primary tumors with an estimated life expectancy of less than three years
- Contraindications for treatment with 5-Fluorouracil or Capecitabine
- Psychological, familial, sociological or geographical condition 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.