Simply Capecitabine in rectal cancer after irradiation plus total mesorectal excision (TME)

ISRCTN	ISRCTN36266738
DOI	https://doi.org/10.1186/ISRCTN36266738
Secondary identifying numbers	NTR552; CKTO 2003 - 16

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 10/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof C.J.H. Velde, van de
Scientific

Leiden University Medical Centre
Department of Surgical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5262309
Email	c.j.h.van_de_velde@lumc.nl

Study information

Study design	Multicentre randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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.
Study acronym	SCRIPT
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2004
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	840
Key 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
Key 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
Date of first enrolment	01/10/2004
Date of final enrolment	01/09/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre

Leiden
2300 RC
Netherlands

Sponsor information

Dutch Colorectal Cancer Group (DCCG), University Medical Centre St Radboud (Netherlands)
Hospital/treatment centre

Department of Medical Oncology 550
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)24 3610353
Email	c.punt@onco.umcn.nl
"ROR"	https://ror.org/00nsb1162

Funders

Funder type

Charity

National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)

No information available

Roche Nederland BV (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2015		Yes	No

Editorial Notes

10/02/2016: Publication reference added