| Source of record | UK Trials |
| ISRCTN | ISRCTN55593137 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LY05 |
| Public title | A randomised trial of radiotherapy alone versus three cycles of cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) chemotherapy plus radiotherapy versus six cycles of CHOP chemotherapy plus radiotherapy for early stage aggressive non-Hodgkins lymphoma |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Colon, rectum |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. Patients with testicular, brain, gastrointestinal or skin primaries are excluded 8. No B symptoms
9. No previous malignancy, except basal cell carcinoma of the skin or cervical carcinoma stage I
10. No evidence of Human Immunodeficiency Virus (HIV) positively
11. No contraindications to protocol treatments |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/10/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55593137 |
| Date last extracted from ISRCTN register | 17/04/2008 |
