Colorectal Cancer Trial, Recruiting NCT06831981 Sponsor: University Hospital Tuebingen Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT06831981
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with rectal cancer (confirmed by tissue testing) where the tumour is located in the lower or middle part of the rectum, within 12 cm of the skin opening of the anus
  • People who are already recommended to receive the type of treatment called total neoadjuvant therapy, regardless of whether they join this trial
  • People whose rectal cancer has been assessed by MRI scan and shows at least one high-risk feature, such as: the tumour growing into nearby structures (cT4), a significant number of affected lymph nodes nearby (cN2), the tumour being very close to or touching the surrounding tissue boundary, involvement of lymph nodes in the side walls of the pelvis, or signs the cancer has grown into nearby blood vessels
  • People who have had a high-quality, detailed MRI scan of the pelvis as part of their staging
  • People who have had a CT scan of the abdomen and chest to check whether the cancer has spread to other parts of the body
  • People aged 18 or older (there is no upper age limit)
  • People who are generally well enough to carry out daily activities with little or no limitation (confirm with trial site regarding the specific fitness score required)
  • People whose blood test results show the liver, kidneys, blood, and metabolism are functioning adequately
  • People who have given their informed consent to participate

Who may not be able to join:

  • People whose tumour is located more than 12 cm from the skin opening of the anus, as measured by a specific type of internal camera examination
  • People whose cancer has a specific genetic feature called "MSI-High" (microsatellite instability), where a different type of treatment using the immune system may be an option instead
  • People who cannot receive hyperthermia (a heat-based treatment) due to having metal implants or a pacemaker in their body
  • People whose cancer has already spread to other parts of the body (distant metastases), as shown on a CT scan
  • People who already experience an inability to control solid bowel movements before joining the trial
  • People who have previously received any cancer treatment for their rectal cancer
  • People who have previously had radiotherapy to the pelvic area
  • People who have had major surgery within the 4 weeks before joining the trial
  • People who are pregnant, breastfeeding, or planning to become pregnant within 6 months after finishing treatment
  • People who are not willing to use highly effective contraception during treatment and for 6 months after treatment ends (this applies to both men and women)
  • People who are currently receiving other cancer treatments at the same time
  • People who have serious ongoing illnesses, including certain neurological or psychiatric conditions, uncontrolled active infections, or an uncontrolled blood clotting disorder
  • People who have had a significant heart condition — such as a heart attack, unstable chest pain, severe heart failure, or serious irregular heartbeat — within the 6 months before joining the trial
  • People who have had another cancer within the past 3 years (exceptions may apply for certain early-stage or skin cancers in people who remain free of that disease — confirm with trial site)
  • People who have had a known allergic reaction to the medications used in this trial
  • People who are known to have a specific genetic enzyme deficiency called dihydropyrimidine dehydrogenase (DPD) deficiency, which affects how certain chemotherapy is processed by the body
  • People whose personal, family, social, or geographical circumstances may make it difficult to follow the trial requirements and attend follow-up appointments

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Cihan Gani, MD, Prof. Dr., University Hospital Tuebingen

Phone: +49 7071 29-82165

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University Hospital Tuebingen
Registry
ClinicalTrials.gov
Start date
11 September 2024
Est. completion
1 June 2036

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Two-year TME-free survival (TMEFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov