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 |
| Protocol serial number | LY05 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, doxorubicin, vincristine and prednisolone |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/11/2019: No publications found. All search options exhausted.
