Contact information
Type
Scientific
Primary contact
Prof C.J.H. Velde, van de
ORCID ID
Contact details
Leiden University Medical Centre
Department of Surgical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR552; CKTO 2003 - 16
Study information
Scientific title
Added 10/08/09:
A Multicenter Phase III Randomised Trial comparing Total Mesorectal Excision with Pre-operative Radiotherapy with or without Post-operative Oral Capecitabine in the Treatment of Operable Primary Rectal Cancer.
Acronym
SCRIPT
Study hypothesis
The overall survival in the arm treated without chemotherapy (TNM-stage II or III tumours) is expected to be approximately 60%. Assuming an improvement in overall survival from 60% to 70% in the arm treated with chemotherapy (TNM-stage II or III tumours), 840 patients are needed; 420 in each arm (alpha 0.05, two sided; power 0.90).
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Rectal cancer, tumour
Intervention
Subjects will be randomised 1:1 to receive either 24 weeks of post-operative treatment (8 courses) with oral capecitabine twice daily, given on days 1-14 every 21 days versus no post-operative treatment (observation).
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
To investigate in rectal cancer patients, in a randomised fashion, whether post-operative chemotherapy leads to a substantial improvement in overall survival, when standardised TME-surgery and pre-operative radiotherapy and pathology are applied.
Secondary outcome measures
1. To investigate in a randomised fashion whether post-operative chemotherapy leads to a substantial improvement in local and distant tumour control, when standardised TME-surgery, pre-operative radiotherapy and pathology are applied
2. Standardisation and quality control of TME-surgery and pathology
Overall trial start date
01/10/2004
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Rectal adenocarcinoma confirmed by histological examination of the biopsy specimen, located below the level of S1/S2 on a barium enema, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan, or located within 15 cm of the anal verge, measured during withdrawal of the flexible scope
2. Preoperative short term hypofractioned radiotherapy (5 x 5 Gy)
3. TME-surgery performed
4. TNM-stage II (T3-T4, N0) or III (any T, N+) as defined by postoperative examination of the resected specimen
5. Start of chemotherapy treatment is possible within 6 weeks after surgery
6. WHO performance score =/< 2
7. Patient is considered to be mentally and physically fit for chemotherapy as judged by the medical oncologist
8. Age >/= 18 years
9. Written informed consent
10. Adequate potential for follow-up
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
840
Participant exclusion criteria
1. Evidence of macroscopic residual disease (R2)
2. T1 or T2 tumour with the presence of micrometastasis without the presence of macrometastasis
3. Contraindications to chemotherapy, including adequate blood counts (measured after recovery from surgery):
3.1. White blood count >/= 4.0 x 10^9/l
3.2. Platelet count >/= 100 x 10^9/l
3.3. Clinically acceptable haemoglobin levels
3.4. Creatinine levels indicating renal clearance of >/= 60 ml/min
3.5. Bilirubin <25 µmol/l
4. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohns disease or active ulcerative colitis
5. Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 10 years.
6. Known DPD deficiency
Recruitment start date
01/10/2004
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Dutch Colorectal Cancer Group (DCCG), University Medical Centre St Radboud (Netherlands)
Sponsor details
Department of Medical Oncology 550
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3610353
c.punt@onco.umcn.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Roche Nederland BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25480874