Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Prof David Cunningham


Contact details

Department of Oncology
Royal Marsden Hospital
Downs Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


R-CHOP 14 vs 21

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.

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Diffuse Large B-Cell Lymphoma


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).

Intervention type



Phase III

Drug names

Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone

Primary outcome measures

The primary endpoint of this study is overall survival.

Secondary outcome measures

The secondary endpoints are:
1. Failure free survival
2. Toxicity
3. Complete response rates

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group



Not Specified

Target number of participants


Participant 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 patient’s ability to give informed consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Oncology
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

Biomedicine Research and Development Unit
Hampstead Campus
Rowland Hill Street
United Kingdom

Sponsor type




Funder type


Funder name

Chugai Pharma Europe Ltd (ref JH/SP)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results - basic reporting

Publication summary

1. 2013 results in

Publication citations

  1. Results

    Cunningham D, Hawkes EA, Jack A, Qian W, Smith P, Mouncey P, Pocock C, Ardeshna KM, Radford JA, McMillan A, Davies J, Turner D, Kruger A, Johnson P, Gambell J, Linch D, Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles., Lancet, 2013, 381, 9880, 1817-1826, doi: 10.1016/S0140-6736(13)60313-X.

Additional files

Editorial Notes