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New treatment option for Locally Recurrent Rectal Cancer
Official title Radiotherapy Dose Escalation for Non-operative Management of Unresectable Locally Recurrent Rectal Cancer (STEP-UP)
ClinicalTrials.gov ID: NCT07721181
What this study is testing
- What it's testing
- The optimal curative-intent management of locally recurrent rectal cancer (LRRC) typically involves multimodality therapy, comprising neoadjuvant therapy and subsequent salvage surgery. However, in patients with unresectable LRRC, where surgical intervention is not feasible, management is limited to non-operative bimodality therapy with systemic therapy and radiotherapy.
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
- Age ≥ 18 years old.
- Diagnosis of locally recurrent rectal cancer, defined as recurrent disease within the pelvis after surgical excision for primary rectal or distal...
- Recurrent disease is determined as unresectable where surgery has been ruled out by clinicians (or refused by patient), with consensus in MDT...
- WHO/ECOG performance score 0-2.
- MR pelvis and thoracoabdominal CT with interpretation no longer than 6 weeks prior to inclusion.
You likely can't join if
- Radiological evidence of extensive metastatic disease (e.g., extensive liver or lung metastases) at time of inclusion, that requires imminent start...
- Radiotherapy in the past 6 months.
- Any contraindication for planned radiotherapy dose escalation, as determined by the radiation oncologist (e.g., residual grade 3 toxicity from...
- Administration of bevacizumab/panitumumab/cetuximab \<6 weeks prior to start radiotherapy dose escalation.
- Severe active morbidity, concomitant disease or active infections.
- dMMR/MSI status
See the full eligibility criteria
- Age ≥ 18 years old.
- Diagnosis of locally recurrent rectal cancer, defined as recurrent disease within the pelvis after surgical excision for primary rectal or distal sigmoidal cancer, diagnosed either by histopathology or clinically proven...
- Recurrent disease is determined as unresectable where surgery has been ruled out by clinicians (or refused by patient), with consensus in MDT. Unresectable is defined as: expected gross incomplete resection with overt...
- WHO/ECOG performance score 0-2.
- MR pelvis and thoracoabdominal CT with interpretation no longer than 6 weeks prior to inclusion.
- Written informed consent according to the ICH-GCP and national/local regulations.
- Radiological evidence of extensive metastatic disease (e.g., extensive liver or lung metastases) at time of inclusion, that requires imminent start of systemic therapy, with consensus in MDT.
- Radiotherapy in the past 6 months.
- Any contraindication for planned radiotherapy dose escalation, as determined by the radiation oncologist (e.g., residual grade 3 toxicity from previous radiotherapy).
- Administration of bevacizumab/panitumumab/cetuximab \<6 weeks prior to start radiotherapy dose escalation.
- Severe active morbidity, concomitant disease or active infections.
- dMMR/MSI status
The study team makes the final eligibility decision.
Where it's taking place
- Arnhem, Netherlands
- Eindhoven, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
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 Arnhem, Netherlands; Eindhoven, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. 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.