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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically proven rectal adenocarcinoma

no distant metastases on CT scan (M0 disease)

T4 tumor (cT4)

N2 disease (cN2)

Disqualifiers

absolute contraindications for MR imaging

distant metastases cannot be reliably excluded

synchronous cancer

chronic inflammatory bowel disease

Trial design

Design model

Factorial

Treatments tested in this trial

  • consolidation chemotherapy

    Other intervention

    6 cycles CAPOX after chemoradiotherapy

  • induction chemotherapy

    Other intervention

    4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: consolidation chemotherapyExperimental treatment 1 intervention
Group B: induction chemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

complete remission rate

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.

Time frame
2 weeks after completiton of TNT

Secondary outcomes

1

Overall survival

time from randomization to death

Time frame
after 3 years of follow-up
2

Survival without recurrence of the disease

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

Time frame
after 3 years of follow-up
3

Disease free survival

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

Time frame
after 3 years of follow-up
4

local control

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

Time frame
after 3 years of follow-up

Other outcomes

Sponsors and contacts

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