MedTrace Logo

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

NCT03170115 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-12-17

No results posted yet for this study

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.

Conditions

  • Rectal Cancer, Adenocarcinoma
  • Locally Advanced Malignant Neoplasm
  • Chemoradiation

Interventions

DRUG

Aspirin

chemoradiotherapy with capecitabine and aspirin Aspirin daily during chemoradiotherapy

DRUG

Placebo Oral Tablet

chemoradiotherapy with capecitabine and placebo Placebo daily during chemoradiotherapy

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Luiz Henrique Araujo, MD, PHD · National Cancer Institute, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2020-01-17
Completion
2020-01-17

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03170115 on ClinicalTrials.gov