Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2.0
Study information
Scientific title
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Diffuse Large B-Cell Lymphoma
Intervention
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
Drug
Phase
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
14/03/2005
Overall trial end date
31/08/2011
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1080
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 patients ability to give informed consent
Recruitment start date
14/03/2005
Recruitment end date
31/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Oncology
Sutton
SM2 5PT
United Kingdom
Funders
Funder type
Industry
Funder name
Chugai Pharma Europe Ltd (ref JH/SP)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 http://www.ncbi.nlm.nih.gov/pubmed/23615461
Publication citations
-
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.