Clinical trial · Interventional
Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer
Phase II Randomized Study of Induction Chemotherapy Followed by Chemoradiotherapy With or Without Aspirin in High Risk Locally Advanced Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Aspirin added to chemoradiotherapy was safe but did not improve response to total neoadjuvant treatment. The study was closed due absence of benefit.
Summary
Brief summary (as posted)
The benefit of aspirin in cancer of the colon and rectum is already known. Recently, it was described its potential activity during chemoradiotherapy, with higher rate of tumor downstaging. Furthermore, induction chemotherapy followed by chemoradiation represents an attractive approach, with more favorable compliance and toxicity profiles. The aim of this study was to evaluate the efficacy of total neoadjuvant treatment and assess the efficacy and feasibility of aspirin use during chemoradiotherapy for high-risk rectal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Cancer, Adenocarcinoma | Malignant Rectal Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aspirin
- description
- Induction chemotherapy followed by chemoradiotherapy with aspirin Aspirin 100mg daily during the chemoradiotherapy
- interventionNames
- Drug: Aspirin
- type
- PLACEBO_COMPARATOR
- label
- Placebo Oral Tablet
- description
- Induction chemotherapy followed by chemoradiotherapy without aspirin Placebo daily during the chemoradiotherapy
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- Tumor downstaging after induction chemotherapy followed by chemoradiotherapy with or without aspirin
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of mid or low rectum 2. 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 3. ECOG performance status of 0-2 4. An informed consent has been signed by the patient Exclusion Criteria: 1. Upper rectal cancer 2. Metastatic disease 3. The patient received any previous therapy for colorectal cancer or another malignancy 4. Other malignant tumours within the last 5 years except cervical carcinoma in situ and basal cell carcinoma of the skin 5. Previous thromboembolic or haemorrhagic events within 6 months prior to registration 6. Patients with malabsorption syndrome or difficulties in swallowing 7. The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy 8. Pregnant of breastfeeding women 9. The patient who participate in another clinical trial, or receives any drug for the trial 10. Uncontrolled peripheral neuropathy (more than grade 2) 11. Active gastrointestinal bleeding
References
Publications (0)
Data not yet available