Simply Capecitabine in rectal cancer after irradiation plus total mesorectal excision (TME)
| ISRCTN | ISRCTN36266738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36266738 |
| Protocol serial number | NTR552; CKTO 2003 - 16 |
| Sponsor | Dutch Colorectal Cancer Group (DCCG), University Medical Centre St Radboud (Netherlands) |
| Funders | National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands), Roche Nederland BV (Netherlands) |
- 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
Scientific
Leiden University Medical Centre
Department of Surgical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262309 |
|---|---|
| c.j.h.van_de_velde@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/02/2016: Publication reference added
