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A phase III multicentre randomised clinical trial comparing rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 14 days and rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell non-Hodgkin's lymphoma
ISRCTN ISRCTN16017947
DOI 10.1186/ISRCTN16017947
ClinicalTrials.gov identifier
EudraCT number
Public title A phase III multicentre randomised clinical trial comparing rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 14 days and rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell non-Hodgkin's lymphoma
Scientific title
Acronym R-CHOP 14 vs 21
Serial number at source 2.0
Study hypothesis R-CHOP 14 vs 21 is a randomised multicentre phase III trial of chemotherapy in patients with untreated diffuse large B cell non-Hodgkin's lymphoma. Its aim is to investigate whether the efficacy of rituximab and cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy given every 21 days for eight cycles can be improved by rituximab and CHOP given every 14 days for six cycles (two additional rituximab infusions will be given after the completion of CHOP).

As of 15/02/2011 the anticipated end date in this trial record has been updated from 01/02/2011 to 31/08/2011.
Lay summary http://www.cancerhelp.org.uk/trials/a-trial-looking-at-treatment-every-2-weeks-or-every-3-weeks-for-non-hodgkins-lymphoma
Ethics approval 1. Hull local research ethics committee on 18/05/2004 (ref: 04/Q1104/27)
2. The Royal Free Hospital & Medical School Research Ethics Committee approved the PET sub study ammendment on 17/09/2008 (added 23/02/10)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Diffuse Large B-Cell Lymphoma
Participants - inclusion criteria 1. Aged over 18 years
2. Histologically proven Diffuse Large B Cell non-Hodgkin's Lymphoma (DLBCL) according to the current World Health Organisation (WHO) classification including all morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel
3. No previous chemotherapy, radiotherapy or other investigational drug for this indication
4. Bulky stage IA (defined as lymph node or lymph node mass greater than 10 cm in diameter), stage II, stage III and IV
5. WHO performance status zero to two
6. Adequate bone marrow function with platelets more than 100 x 10^9/l, neutrophils more than 1.5 x 10^9/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma
7. Serum creatinine less than 150mmol/l, serum bilirubin less than 35mmol/l and transaminases less than 2.5 upper limit of institutional normal range unless attributed to lymphoma
8. Normal MUltiple-Gated Acquisition (MUGA) scan or EchoCardioGram (ECG) without any areas of abnormal contractility. Patients must have an acceptable Left Ventricular Ejection Fraction (LVEF) = 50% (only applicable if aged over 70, known diabetic over 65, past history of cardiac disease or hypertension or abnormal resting ECG)
9. No concurrent uncontrolled medical condition
10. No active malignant disease other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last ten years
11. Life expectancy more than three months
12. Adequate contraceptive precautions for all patients of childbearing potential
13. Written, informed consent
Participants - exclusion criteria 1. T-cell lymphoma or transformed follicular lymphoma
2. Previous history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed who have a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included
3. Past history of heart failure or uncontrolled angina pectoris
4. Central nervous system, meningeal involvement or cord compression by the lymphoma
5. Cardiac contra-indication to doxorubicin (abnormal contractility on echocardiography or nuclear medicine examination [MUGA])
6. Neurological contra-indication to vincristine (e.g. pre-existing diabetic neuropathy)
7. Any other serious active disease
8. General status that does not allow the administration of eight courses of CHOP according to the investigator
9. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
10. Medical or psychiatric conditions that compromise the patientís ability to give informed consent
Anticipated start date 14/03/2005
Anticipated end date 31/08/2011
Status of trial Completed
Patient information material
Target number of participants 1080
Interventions Arm A: R-CHOP 21: eight cycles of CHOP and eight cycles of rituximab, every 21 days
Arm B: R-CHOP 14: six cycles of CHOP and eight cycles of rituximab, every 14 days

Please note that this trial has been extended to include the PET sub study. The previous end date was 14/03/2008. As of 23/02/10 recruitment for the PET sub study is ongoing and recruitment for the main R-CHOP study has been completed (target reached Nov 2008).
Primary outcome measure(s) The primary endpoint of this study is overall survival.
Secondary outcome measure(s) The secondary endpoints are:
1. Failure free survival
2. Toxicity
3. Complete response rates
Sources of funding Chugai Pharma Europe Ltd (ref JH/SP)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23615461
Contact name Prof  David  Cunningham
  Address Department of Oncology
Royal Marsden Hospital
Downs Road
  City/town Sutton
  Zip/Postcode SM2 5PT
  Country United Kingdom
Sponsor University College London (UK)
  Address Biomedicine Research and Development Unit
Hampstead Campus
Rowland Hill Street
  City/town London
  Zip/Postcode NW3 2PF
  Country United Kingdom
Date applied 05/09/2006
Last edited 28/05/2013
Date ISRCTN assigned 04/10/2006
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