A second UK Phase III anal cancer trial: a trial of chemoradiation and maintenance therapy for patients with anal cancer
| ISRCTN | ISRCTN26715889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26715889 |
| ClinicalTrials.gov number | NCT00025090 |
| Secondary identifying numbers | ACT II |
- Submission date
- 31/05/2001
- Registration date
- 31/05/2001
- Last edited
- 17/10/2018
- 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
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 contact details to request a participant information sheet |
| Scientific title | A second UK Phase III anal cancer trial: a trial of chemoradiation and maintenance therapy for patients with anal cancer |
| Study acronym | ACT II |
| Study objectives | Following completion of ACT I the standard treatment for anal cancer is a combined modality treatment of radiotherapy, 5-Fluorouracil (5-FU) and mitomycin. However, the schedule used in ACT I may not be optimal and an improvement in outcome may be achieved by intensifying. United Kingdom, European Organisation for Research and Treatment of Cancer (EORTC) and Intergroup pilot studies used three main approaches: 1. Modification of radiotherapy schedule 2. Changing the chemotherapy regimen 3. Additional courses of chemotherapy. As a result, to avoid using split course radiotherapy a continuous course of radiotherapy (piloted in over 80 patients) will be used in this trial, cisplatin will be compared to mitomycin and patients will be randomised to maintenance chemotherapy. Cisplatin was chosen as in combination with 5-FU it is active in advanced disease, it produces high Complete Remission (CR) rates in combination with radiotherapy and has activity in other squamous cell carcinomas. Additional chemotherapy will be given after treatment as neo-adjuvant chemotherapy has not been shown to improve survival when given in combination with radiotherapy in other tumour sites. In addition the toxicity associated with it may impact on the timing of treatment and on the total dose of chemoradiation delivered. Therefore, the objectives of this trial are as follows: 1. Whether Cisplatin or Mitomycin produces a higher CR rate post treatment 2. Whether Cisplatin or Mitomycin produces a higher grade four acute toxicity 3. Whether maintenance chemotherapy will improve recurrence-free survival |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Anal cancer |
| Intervention | Four treatment arms: 1. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Mitomycin 12 mg/m^2, day one only, intravenous (iv) bolus and no maintenance therapy 2. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Mitomycin 12 mg/m^2, day one only, iv bolus and maintenance therapy (CDDP) 3. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Cisplatin 60 mg/m^2, days one and 29 by iv infusion and no maintenance therapy 4. 5-Fluorouracil 1000 mg/m^2, days one to four and 29 to 32 by 24 hour continuous infusion and Cisplatin 60 mg/m^2, days one and 29 by iv infusion and maintenance therapy (CDDP) Maintenance therapy consists of: Two courses 5-FU and Cisplatin, four weeks after the end of primary chemoradiation repeated after three weeks: 5-Fluorouracil 1000 mg/m^2, days one to four and Cisplatin 60 mg/m^2, day one by iv infusion |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 5-Fluorouracil, Mitomycin and Cisplatin |
| Primary outcome measure | 1. CR rate (at six months): 1.1. 90% to detect an increase from 80% to 90% 1.2. 95% to detect an increase from 85% to 95% 2. Grade four toxicity: 95% to detect a doubling of the 11% Grade four acute toxicity reported in ACT I 3. Recurrence-free survival: 3.1. 80% to detect 11% difference (64% to 75%) 3.2. 99% to detect 16% difference (64% to 80%) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2001 |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Histological proof of epidermoid anal carcinoma (includes squamous, basaloid and cloacogenic lesions) 2. Patients fit to receive platinum or mitomycin C based chemotherapy determined by: 2.1. Adequate baseline renal function 2.2. Acceptable haematological parameters 2.3. Liver Function Tests (LFTs) within 2 x normal range 2.4. Adequate cardiac function 2.5. No serious uncontrolled medical conditions (particularly cardiovascular disease) 2.6. Written informed consent |
| Key exclusion criteria | 1. Anal cancer that has spread to another part of the body 2. Adenocarcinoma or muco-epidermoid anal cancer 3. Lymphoma or melanoma of the anal canal 4. Pre-cancerous cell changes (intraepithelial neoplasia) that have not developed into anal cancer 5. Had your cancer completely removed with an operation 6. Already had treatment for your anal cancer 7. Had radiotherapy to your pelvic area before 8. Had any other cancer in the past 9. Any other serious medical condition |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
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 (CRUK) (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/08/2014 | Yes | No | |
| Results article | post-hoc analysis results | 01/03/2017 | Yes | No |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
20/02/2017: Publication reference added.
