Clinical trial · Interventional
Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
Phase II Study of Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced High-risk Rectal Cancer
- 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)
Short-course radiotherapy followed by consolidation chemotherapy has shown a better response rate when compared to chemoradiotherapy treatment. In addition, recent studies have shown better tolerance with total neoadjuvant treatment, with induction or consolidation chemotherapy. Induction chemotherapy could reduce the size of the tumor, treat micrometastases early and allow treatment to start immediately (avoiding potential delays in waiting for radiotherapy). While consolidation chemotherapy allows longer waiting times for surgery, with higher response rates.
Conditions
Conditions (2)
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 |
| Total Neoadjuvant Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Approach | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
- interventionNames
- Other: Approach
Primary outcomes (1)
- measure
- Evaluate MRI good response rate after the total neoadjuvant treatment
- timeFrame
- 16-20 weeks after SCRT
- description
- Good response rate is defined as the proportion of patients who reached mrTRG 1 or 2 and the absence of remote disease in the reevaluation period, with the denominator being the total number of patients who started total neoadjuvant treatment.
Secondary outcomes (3)
- measure
- Disease-free survival in 3 years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of mid or low rectum * Locally advanced rectal cancer with one of the high-risk factors confirmed by high-resolution thin-slice Magnetic resonance image (3 mm) tumors extending to within 1 mm of, or beyond the mesorectal fascia; tumor extending 5 mm or more into perirectal fat; resectable cT4 tumors; lower third; nodal involvement; extramural vascular invasion * ECOG performance status of 0-2 * An informed consent has been signed by the patient Exclusion Criteria: * Upper rectal cancer * Metastatic disease * The patient received any previous therapy for colorectal cancer or another malignancy * Other malignant tumours within the last 5 years except cervical carcinoma in situ and basal cell carcinoma of the skin * Previous thromboembolic or haemorrhagic events within 6 months prior to registration * Patients with malabsorption syndrome or difficulties in swallowing * The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy * Pregnant of breastfeeding women * The patient who participate in another clinical trial, or receives any drug for the trial * Uncontrolled peripheral neuropathy (more than grade 2)
References
Publications (0)
Data not yet available