Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer

• Status: Terminated
• Trial end date: 2020-01-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancer, Brazil
• Treatments: Aspirin

Criteria

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