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

NCT03170115 | Terminated Phase 2

• 1 other identifier: ICAR trial
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rectal Cancer; Total neoadjuvant therapy; Induction chemotherapy; Aspirin colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Tumor downstaging after induction chemotherapy followed by chemoradiotherapy with or without aspirin

  This will be assessed by MR imaging 8-10 weeks after chemoradiotherapy and it will be considered tumor downstaging if mrTRG 1 to 3

  8-10 weeks after chemoradiotherapy

Secondary Outcomes (5)

• Radiological Tumor response rate after induction chemotherapy

  3-4 weeks after last induction chemotherapy

• Pathological Tumor response rate

  10-12 weeks after chemoradiotherapy

• Pathologic complete response

  8-10 weeks after chemoradiotherapy

• Disease-free survival

  3 years

• Overall survival

  5 years

Study Arms (2)

Aspirin

EXPERIMENTAL

Induction chemotherapy followed by chemoradiotherapy with aspirin Aspirin 100mg daily during the chemoradiotherapy

Drug: Aspirin

Placebo Oral Tablet

PLACEBO COMPARATOR

Induction chemotherapy followed by chemoradiotherapy without aspirin Placebo daily during the chemoradiotherapy

Drug: Placebo Oral Tablet

Interventions

Aspirin DRUG

chemoradiotherapy with capecitabine and aspirin Aspirin daily during chemoradiotherapy

Also known as: aas

Aspirin

Placebo Oral Tablet DRUG

chemoradiotherapy with capecitabine and placebo Placebo daily during chemoradiotherapy

Also known as: placebo

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Active gastrointestinal bleeding

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

INCA- Instituto Nacional de Câncer

Rio de Janeiro, 20231-050, Brazil

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Aspirin; N-hydroxy-4-acetylaminostilbene

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Luiz Henrique Araujo, MD, PHD

  National Cancer Institute, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: preoperative induction chemotherapy followed by combined radiochemotherapy with capecitabine and aspirin

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 30, 2017
• Study Start: November 30, 2017
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)