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

Institute of Oncology Ljubljana

Status and phase: Enrolling; Phase 2

Conditions: Locally Advanced Rectal Cancer

Treatments: Other: induction chemotherapy; Other: consolidation chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05054959

KME 0120-214/2021/3

Details and patient eligibility

About

The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

Full description

International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 MR imaging:

  • 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

consolidation chemotherapy

Experimental group

Description:

chemoradiation: intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant CT with capecitabine (dosage: 825 mg / m2 / 12 h per os continuously from the first to the last day of irradiation). 6 cycles of CAPOX chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg / m2 / 12h per os for 1-14 days and oxaliplatin 130 mg / m2 intravenously in a two-hour infusion on day 1.

Treatment:

Other: consolidation chemotherapy

induction chemotherapy

Active Comparator group

Description:

4 cycles of induction CAPOX chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg / m2 / 12h per os for 1-14 days and oxaliplatin 130 mg / m2 intravenously in a two-hour infusion on day 1. Chemoradiation:intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant CT with capecitabine (dosage: 825 mg / m2 / 12 h per os continuously from the first to the last day of irradiation). 2 cycles of consolidation CAPOX chemotherapy.

Treatment:

Other: induction chemotherapy