Clinical trial • Phase IV • Oncology

Capecitabine for Rectal cancer|Rectal adenocarcinoma

Phase IV trial of Capecitabine for Rectal cancer|Rectal adenocarcinoma. 100 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Rectal cancer|Rectal adenocarcinoma
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-09-2024
First CTIS Authorization Date
24-09-2024

Trial design

Phase IV trial across 2 sites in Finland.

Target Sample Size
100

Eligibility

Recruits 100 Vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent documentation is provided (documents listed: 'Tiedote tutkittavalle SYNCOPE' and 'Suostumus tutkimukseen'). Consent to be provided by participant; no assent procedures or specific vulnerable-population consent arrangements are specified in the provided data..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent documentation is provided (documents listed: 'Tiedote tutkittavalle SYNCOPE' and 'Suostumus tutkimukseen'). Consent to be provided by participant; no assent procedures or specific vulnerable-population consent arrangements are specified in the provided data.

Inclusion criteria

  • {"criterion_text":"- 1) rectal adenocarcinoma"}
  • {"criterion_text":"- 2) WHO performance status 0-1, assessed by the MDT to be able to undergo CAPOX (capecitabine and oxaliplatin) treatment"}
  • {"criterion_text":"- 3) mrEMVI+"}
  • {"criterion_text":"- 4) assessed by the MDT to require either RT or CRT by the current standards. In general, indications for clinical rectal carcinoma MDT to recommend RT or CRT are: T3-4 tumor at mid- or low rectum location, involvement of lymph nodes, threatened operative margin or mrEMVI"}

Exclusion criteria

  • {"criterion_text":"- 1.) deficient MMR status, non-DPYD genotype"}
  • {"criterion_text":"- 2) a contraindication to capecitabine, oxaliplatin or RT"}
  • {"criterion_text":"- 3) failing in blood tests that describe the adequate circulatory"}
  • {"criterion_text":"- 4) liver and kidney function for chemotherapy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Recurrence-free survival at 3 (and 5) years at intention-to-treat analysis","definition_or_measurement_approach":"Recurrence-free survival measured at 3 and 5 years using an intention-to-treat analysis (time-to-event endpoint as stated)."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
66
Consent Approach
Informed consent documents are provided ('Tiedote tutkittavalle SYNCOPE' and 'Suostumus tutkimukseen'). Consent is expected from participants themselves; no assent or additional age-specific consent documents or languages are specified in the provided data.

Geography

Total Number Of Sites
2
Total Number Of Participants
100

Finland

Earliest CTIS Part Ii Submission Date
22-08-2024
Latest Decision Or Authorization Date
24-09-2024
Processing Time Days
33
Number Of Sites
2
Number Of Participants
100

Sites

Site Name
Tampere University Hospital
Department Name
Gastroenterology
Contact Person Name
Erkki-Ville Wirta
Contact Person Email
erkki-ville.wirta@pirha.fi
Site Name
HUS-Yhtymae
Department Name
Gastrology
Contact Person Name
Toni Seppälä
Contact Person Email
toni.seppala@tuni.fi

Sponsor

Primary sponsor

Full Name
HUS-Yhtymae
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Capecitabine Orion 150 mg kalvopäällysteiset tabletit
Active Substance
Capecitabine
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
2000 mg/m2
Investigational Product Name
Oxaliplatin Accord 5 mg/ml, infuusiokonsentraatti, liuosta varten.
Active Substance
Oxaliplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
85 mg/m2
Combination Treatment
Yes

Related trials

Other published trials that may interest you.