Clinical trial · Interventional
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
NCT05883800CI-TRIAL-00075163TNT-RECORDrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| On-couch adaptive radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Intervention: daily on-couch adaptive radiotherapy
- interventionNames
- Radiation: On-couch adaptive radiotherapy
Primary outcomes (1)
- measure
- Incidence of acute gastro-intestinal toxicity equal or higher than grade 2
- timeFrame
- Up to administration of the last course of chemotherapy or week 22, whichever comes first
- description
- Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5.
Secondary outcomes (6)
- measure
- Number of participants that require alteration of chemotherapy due to toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered. * ECOG status ≤ 1 * Being willing and able to give full written consent for participation Exclusion Criteria: * Previous rectal cancer treatment * Previous irradiation to the treatment area e.g. prostate cancer * Hip prosthesis * Contraindications to MRI * Pregnancy * Abnormal DPYD genotype * Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators
References
Publications (0)
Data not yet available
No reference posted for this study.