ISRCTN - ISRCTN36266738: Simply Capecitabine in rectal cancer after irradiation plus total mesorectal excision (TME)

Plain English Summary

Not provided at time of registration

Trial website

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