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NCT Number: NCT05054959

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

The purpose of this study is to identify the most promising treatment sequence in total neoadjuvant therapy for locally advanced rectal cancer with a high risk of recurrence.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Locally Advanced Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Oncology

Ljubljana, Slovenia, 1000

About this study

International recommendations for the treatment of locally advanced rectal cancer with a high risk of disease recurrence are inconsistent regarding the optimal sequence of total neoadjuvant therapy. In a German randomized study, a higher rate of pathological complete response was observed with consolidation chemotherapy.

This study compares induction chemotherapy followed by chemoradiotherapy and consolidation chemotherapy with chemoradiotherapy followed by consolidation chemotherapy in patients with locally advanced rectal cancer and high-risk features for recurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- histologically proven rectal adenocarcinoma

  • no distant metastases on CT scan (M0 disease)
  • at least one high risk factor for disease recurrence identified on magnetic resonance imaging (MRI):
  • T4 tumor (cT4)
  • N2 disease (cN2)
  • extramural venous invasion (cEMVI+)
  • positive lateral lymph nodes
  • distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)
  • capacity for informed consent
  • willingness to attend regular check-ups during and after treatment

Exclusion criteria

history of previous irradiation in the pelvic area

  • absolute contraindications for MR imaging
  • distant metastases cannot be reliably excluded
  • synchronous cancer
  • chronic inflammatory bowel disease

Treatment and study plan

Consolidation CAPOX Chemotherapy

Drug

Six cycles of CAPOX chemotherapy are administered after chemoradiotherapy. CAPOX consists of capecitabine and oxaliplatin according to the study protocol.

Induction CAPOX Chemotherapy

Drug

Four cycles of CAPOX chemotherapy are administered before chemoradiotherapy, followed by two cycles of CAPOX chemotherapy after chemoradiotherapy. CAPOX consists of capecitabine and oxaliplatin according to the study protocol.

Primary outcomes

  1. complete remission rate

    Time frame: 2 weeks after completion of TNT

    The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients.

Secondary outcomes

  1. Overall survival

    Time frame: after 3 years of follow-up

    time from randomization to death

  2. Survival without recurrence of the disease

    Time frame: after 3 years of follow-up

    time from the end of treatment (in case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first.

  3. Disease free survival

    Time frame: after 3 years of follow-up

    the time from the end of treatment (in the case of cCR) or surgery to the recurrence of disease, the onset of new cancer, death from cancer or other causes

  4. local control

    Time frame: after 3 years of follow-up

    the time from the end of the treatment (in the case of cCR) or surgery to local recurrence

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Locally Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)

Acronym: ICONA

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Sep 23, 2021
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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