| Source of record | National Research Register |
| Serial number at source | N0046002812 |
| Project title | BNLI : rANDOMISED COMPARISON OF CYCLICAL ANTHRACYCLINE-BASED CHEMOTHERAPY [PA(B1)OE] WITH ALTERNTING CHEMOTHERAPY [CH1VPP/PAB1OE] IN ADVANCED HODGKIN'S DISEASE |
| Current status of trial | Ongoing |
| Main research question | To examine new schedules for the treatment of Hodgkin's Disease |
| Design/methodology | Adriamycin - 40mg/m(2) iv day 1
Vincristine - 1.4mg/m(2) (max 2mg) iv days 1 and 8
Prednisolone - 40mg/m(2) (max 60mg) po daily for 10 days
Etoposide - 200mg/m(2) po daily for 3 days
Bleomycin - 10mg/m(2) iv days 1 and 8 for first 4 courses only
I nadir (day 10-14) wbc <1.0 x 10(9)/1 decrease etoposide to 2 days. If nadir wbc >1.5 x 10(9)/1 increase etoposide to 4 days
A minimum of 6 courses will be given with at least 2 following documenttion of clinical complete remissin and a maximum of 8 course. BLEOMYCIN SHOULD NOT BE GIVEN FOR MORE THAN 4 COURSES
The Ch1VPP/PAB1OE regimen consists of :
Chlorambucil - 6mg/m(2) (max 10mg) po daily
Procarbazine - 100 mg/m(2) (max 200mg) po daily
Prednisolone - 40mg/m(2) (max 60mg) po daily
Vinbalstine - 6mg/m(2) (max 10mg) iv days 1 and 8
PAB1OE (as 7.1 above)
the alternation of Ch1VPP/PAB1OE consists of initial treatment with Ch1VPP for 2 weeks followed by a 2 week gap with no chemotherapy. At the beginning f the fifth week PAB1OE is given and lasts for two weeks. There is a further one week gap without chemotherapy and then the next cycle of Ch1VPP is given. The total cycle Ch1VPP/PAB1OE takes 7 weeks. A minimum of 6 courses (3Ch1VPP; 3PAB1OE) must be given with at least 2 courses of chemotherapy after clinical complete remission hs been achieved - maximum 8 courses. |
| Sample group description | Previously untreated and properly staged patients aged between 15 and 69 years (inclusive) with Hodgkin's disease, for whom chemotherapy is indicated, are eligible. Patients must be free from any irreversible medical condition that would drastically limit their life span or prohibit the use of combination chemotherapy. This applies particularly to elderly patients. Adequate long term follow up must be possible. patients must have given written, informed consent. |
| Multi-centre trial? | This is not a multi-centre trial. |
| Outcome measure | 1. To compare the Ch1VPP/PAB1OE alternating regimen with PA(B1)OE alone in the treatment of advanced Hodgkin's disease, with respect to complete remission (CR) rate and relapse free and overall survival in a randomised prospective trial in patient for whom chemotherapy is indicated.
2. To reduce potential pulmonary toxicity Bleomycin is included only for the first four courses of PAB1OE hence the designation 'PA)B1)OE'
3. to document the toxicity of each regimen with regard to, in particular, the frequency of second malignancy, infertility, pulmonary and cardiac toxicity
4. To assess in a randomised study the role of radiotherapy (RT) following chemotherapy induced CR
5. to asses 'quality of life' in patients undergoing treatement within each arm of the study |
| Start date | 12/01/1993 |
| End date | 11/30/2003 |
| Primary keywords | ANTINEOPLASTIC-AGENTS-COMBINED Q-therapeutic-use; HODGKIN-DISEASE Q-drug-therapy |
| Secondary keywords | DOXORUBICIN Q-administration-&-dosage; VINCRISTINE Q-administration-&-dosage; PREDNISOLONE Q-administration-&-dosage; ETOPOSIDE Q-administration-&-dosage; BLEOMYCIN Q-administration-&-dosage; CHLORAMBUCIL Q-administration-&-dosage; PROCARBAZINE Q-administration-&-dosage; VINBLASTINE Q-administration-&-dosage; RANDOMIZED-CONTROLLED-TRIAL; FOLLOW-UP-STUDIES; ADOLESCENCE; ADULT; MIDDLE-AGE; AGED; SURVIVAL-RATE; COMPARATIVE-STUDY |
| Region | West Midlands Regional Office |
| NRR Data Provider | Birmingham Heartlands and Solihull NHS Trust |
| Funding organisation: name 1 | British National Lymphoma Investigation |
| Contact name(s) | Dr Don Milligan |
| Contact details |
Tel: 0121 766 6611 ex. 4272
Fax: 0121 766 7530 |
| Further information | This record was taken from the National Research Register 2003, Issue 1, published in February 2003. Further information about this trial can be obtained from the lead researcher named above. |
| Date live in mRCT | 6 February 2003 |
