A randomised trial of radiotherapy alone versus three cycles of cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) chemotherapy plus radiotherapy versus six cycles of CHOP chemotherapy plus radiotherapy for early stage aggressive non-Hodgkin's lymphoma
| ISRCTN | ISRCTN55593137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55593137 |
| Secondary identifying numbers | LY05 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 21/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised trial of radiotherapy alone versus three cycles of cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) chemotherapy plus radiotherapy versus six cycles of CHOP chemotherapy plus radiotherapy for early stage aggressive non-Hodgkin's lymphoma |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Non-Hodgkin's lymphoma |
| Intervention | Patients are randomised to one of three treatment regimens: 1. Regimen A: Radiotherapy 40 Gy in twenty to twenty-five fractions. 2. Regimen B: Chemotherapy with cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) repeated every 21 days for three cycles. Radiotherapy 30 Gy in fifteen fractions for patients in complete remission or 40 Gy in twenty to twenty-five fractions for patients who are not in chemotherapy induced complete remission. 3. Regimen B: Chemotherapy with cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) repeated every 21 days for six cycles. Radiotherapy 30 Gy in fifteen fractions for patients in complete remission or 40 Gy in twenty to twenty-five fractions for patients who are not in chemotherapy induced complete remission. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, doxorubicin, vincristine and prednisolone |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1990 |
| Completion date | 31/10/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Biopsy-proven non-Hodgkin's lymphoma of any of the following histologies: International Working Formulation groups F, G and H; Kiel Classification: centroblastic B-cell, pleomorphic medium and large T-cell, immunoblastic, large cell anaplastic and high grade unclassified; Revised European-American Classification of Lymphoid Neoplasms (REAL Classification): Diffuse large B-cell, anaplastic large cell, high-grade B-cell or Mucosa-associated lymphoid tissue (MALT) type, and peripheral T-cell 2. WHO performance status 0, 1, 2 3. Aged greater than 15 years 4. No previous chemotherapy or radiotherapy 5. Normal lactic dehydrogenase (LDH) 6. Stage I, IE, II, IIE, except bulky abdominal presentation 7. No B symptoms 8. No previous malignancy, except basal cell carcinoma of the skin or cervical carcinoma stage I 9. No evidence of Human Immunodeficiency Virus (HIV) positively 10. No contraindications to protocol treatments |
| Key exclusion criteria | Patients with testicular, brain, gastrointestinal or skin primaries are excluded |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 31/10/1996 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
-
-
-
United Kingdom
-
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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 |
Editorial Notes
21/11/2019: No publications found. All search options exhausted.
