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 | https://doi.org/10.1186/ISRCTN16017947 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 05/09/2006
- Registration date
- 04/10/2006
- Last edited
- 28/05/2013
- 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
Contact information
Prof David Cunningham
Scientific
Scientific
Department of Oncology
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | R-CHOP 14 vs 21 |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone |
| Primary outcome measure | 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 study start date | 14/03/2005 |
| Completion date | 31/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 1080 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/03/2005 |
| Date of final enrolment | 31/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Oncology
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Biomedicine Research and Development Unit
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Industry
Chugai Pharma Europe Ltd (ref JH/SP)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 25/05/2013 | Yes | No |
