Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer

NCT04674696 | Unknown Phase 2

• 1 other identifier: SHORT-ICAR
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer; Total Neoadjuvant Treatment

Keywords

rectal cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate MRI good response rate after the total neoadjuvant treatment

  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.

  16-20 weeks after SCRT

Secondary Outcomes (3)

• Disease-free survival in 3 years

  3 years

• Overall survival

  3 years

• Describe the safety and tolerability of total neoadjuvant treatment.

  1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.

Other: Approach

Interventions

Approach OTHER

Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.

Experimental

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)

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

INCA- Instituto Nacional de Câncer

Rio de Janeiro, 20231-050, Brazil

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

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

Study Officials

• Juliana Souza

  Instituto Nacional de Cancer, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Souza

CONTACT

5521988734435; juominelli@hotmail.com

Isabele Small

CONTACT

00552132076666; ismall@inca.gov.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: November 10, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 19, 2020

Record last verified: 2020-11

Locations

BR (1)