Clinical trial • Phase II • Oncology|Gastroenterology

Capecitabine for Rectal cancer

Phase II trial of Capecitabine for Rectal cancer.

Overview

Trial Therapeutic Area
Oncology|Gastroenterology
Trial Disease
Rectal cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-09-2024
First CTIS Authorization Date
08-10-2024

Trial design

Randomised, capecitabine pharmacare 150 mg film-coated tablets; capecitabine accord 500 mg film-coated tablets-controlled Phase II trial across 7 sites in Denmark.

Randomised
Yes
Comparator
Capecitabine Pharmacare 150 mg film-coated tablets; Capecitabine Accord 500 mg film-coated tablets
Target Sample Size
124

Eligibility

Recruits 124 No vulnerable populations selected. Participants must be adults ("Age at least 18 years"). Informed consent is required: "Written and orally informed consent" (subject information and informed consent form document available). No assent procedures described..

Pregnancy Exclusion
Pregnant (positive pregnancy test) or breast feeding women
Vulnerable Population
No vulnerable populations selected. Participants must be adults ("Age at least 18 years"). Informed consent is required: "Written and orally informed consent" (subject information and informed consent form document available). No assent procedures described.

Inclusion criteria

  • {"criterion_text":"- Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge."}
  • {"criterion_text":"- Locally advanced tumor based on imaging (Tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to DCCG guidelines, T3c or T4 tumors 10-15 cm from the anal verge)."}
  • {"criterion_text":"- Deemed resectable at the multidisciplinary team (MDT) conference."}
  • {"criterion_text":"- ECOG performance status 0-2."}
  • {"criterion_text":"- Age at least 18 years."}
  • {"criterion_text":"- Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l., Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, Calculated or measured renal glomerular filtration rate at least 30 mL/min)."}
  • {"criterion_text":"- Anticonception for fertile women and for male patients with a fertile partner."}
  • {"criterion_text":"- Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable."}
  • {"criterion_text":"- Written and orally informed consent"}

Exclusion criteria

  • {"criterion_text":"- Distant metastasis"}
  • {"criterion_text":"- Invasive ingrowth into other organs"}
  • {"criterion_text":"- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy"}
  • {"criterion_text":"- Previous radiotherapy to the pelvis"}
  • {"criterion_text":"- Previous treatment with 5FU or oxaliplatin"}
  • {"criterion_text":"- Surgery within two weeks"}
  • {"criterion_text":"- Neuropathy NCI grade > 1"}
  • {"criterion_text":"- Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri"}
  • {"criterion_text":"- Pregnant (positive pregnancy test) or breast feeding women"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease free survival","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Local and distant relapse","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Early and late toxicity","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Functional outcome and QoL","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Resection rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Postoperative morbidity","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Postoperative mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Rate of downsizing","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Tumor regression grade","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Translational research","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
124
Recruitment Window Months
165
Consent Approach
Written and orally informed consent required ("Written and orally informed consent"). Subject information and informed consent form available (document: 'Deltagerinf version 2'). Participants are adults (age ≥18) so consent provided by participant; no assent processes described; languages not specified.

Geography

Total Number Of Sites
7
Total Number Of Participants
124

Denmark

Earliest CTIS Part Ii Submission Date
02-10-2024
Latest Decision Or Authorization Date
08-10-2024
Processing Time Days
6
Number Of Sites
7
Number Of Participants
124

Sites

Site Name
Region Nordjylland
Department Name
Department of Oncology
Contact Person Name
Laurids Østergaard Poulsen
Contact Person Email
laop@rn.dk
Site Name
Region Syddanmark
Department Name
Vejle Sygehus
Contact Person Name
Lars Henrik Jensen
Contact Person Email
Lars.henrik.jensen@rsyd.dk
Site Name
Region Syddanmark
Department Name
Department of Oncology
Contact Person Name
Per Pfeiffer
Contact Person Email
Per.Pfeiffer@rsyd.dk
Site Name
Region Midtjylland
Department Name
Department of Surgery
Contact Person Name
Lene Iversen
Contact Person Email
lene.h.iversen@dadlnet.dk
Site Name
Region Hovedstaden
Department Name
Department of Oncology
Contact Person Name
Anne-Lene Fromm
Contact Person Email
anna-Lene.fromm@regionh.dk
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Camilla Qvortrup
Contact Person Email
Camilla.qvortrup@regionh.dk
Site Name
Region Sjaelland
Department Name
Department of Surgery
Contact Person Name
Ismail Gögenur
Contact Person Email
Igo@regionsjaelland.dk

Sponsor

Primary sponsor

Full Name
Region Sjaelland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"University of Southern Denmark","duties_or_roles":"1","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
Capecitabine Pharmacare 150 mg film-coated tablets
Active Substance
Capecitabine
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Investigational Product Name
Capecitabine Glenmark 500 mg filmomhulde tabletten
Active Substance
Capecitabine
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Investigational Product Name
Capecitabine Accord 500 mg film-coated tablets
Active Substance
Capecitabine
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Investigational Product Name
Oxaliplatin 5mg/ml concentrate for Solution for Infusion
Active Substance
Oxaliplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
2
Investigational Product Name
Capecitabine Glenmark 150 mg film-coated tablets
Active Substance
Capecitabine
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Investigational Product Name
5-FU medac 50 mg/ml, Injektionslösung
Active Substance
Fluorouracil
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Investigational Product Name
Leucovorin 10 mg/ml Lösung zur Injektion/ Infusion
Active Substance
Calcium folinate pentahydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Combination Treatment
Yes

Related trials

Other published trials that may interest you.