First International Randomised trial in Locally Advanced and Metastatic Adrenocortical Cancer Treatment - Etoposide, Doxorubicin, Cisplatin and Mitotane versus Streptozotocin and Mitotane
ISRCTN | ISRCTN94256573 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN94256573 |
Secondary identifying numbers | CO-ACT-001 |
- Submission date
- 22/08/2005
- Registration date
- 16/09/2005
- Last edited
- 20/08/2008
- 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
Prof Britt Skogseid
Scientific
Scientific
University Hospital Uppsala
Entrance 40, 5th floor
Uppsala
75185
Sweden
Phone | +46 186113768 |
---|---|
britt.skogseid@medsci.uu.se |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | FIRM-ACT |
Study objectives | Primary objective of this trial is to investigate whether Etoposide, Doxorubicin, Cisplatin plus Mitotane (EDP-M) as first line treatment will prolong survival as compared to Streptozotocin plus Mitotane (Sz-M) as first line treatment for advanced Adrenocortical Carcinoma (ACC). |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Adrenocortical Carcinoma |
Intervention | Etoposide, Doxorubicin, Cisplatin plus Mitotane (EDP/M) or Streptozotocin plus Mitotane (Sz/M) as first line treatment. The syudy protocol is available on http://www.firm-act.org/documents/FIRM_ACT_Synopsis.pdf and http://www.firm-act.org/documents/FIRM_ACT_protocol_final.pdf |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Etoposide, Doxorubicin, Cisplatin and Mitotane versus Streptozotocin and Mitotane |
Primary outcome measure | Overall survival |
Secondary outcome measures | 1. Quality of life as measured by EORTC QLQ-C30 2. Time to progression 3. Best overall response rate and duration of response 4. Number of disease-free patients 5. Impact of reaching mitotane blood levels between 14-20 mg/l in both arms on survival and best overall response rate 6. Best overall response rate of both regimens as second line treatment in case of failure of the initial other regime |
Overall study start date | 01/07/2004 |
Completion date | 31/12/2011 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 300 |
Key inclusion criteria | 1. Histologically confirmed diagnosis of adrenocortical carcinoma 2. Locally advanced or metastatic disease not amenable to radical surgical resection (Stage III-IV) 3. Radiologically monitorable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status zero to two 5. Life expectancy more than three months 6. Age above 18 years 7. Adequate bone marrow reserve (neutrophils more than or equal to 1500/mm^3 and platelets more than or equal to 100,000/mm^3) 8. Effective contraception in pre-menopausal female and male patients 9. Patients written informed consent 10. Ability to comply with the protocol procedures (including availability for follow-up visits) 11. Previous palliative surgery, radiotherapy or radiofrequency ablation is acceptable as long as radiologically monitorable disease is verifiable afterwards. |
Key exclusion criteria | 1. History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other cancers treated with no evidence of disease for at least five years 2. Previous cytotoxic chemotherapy (prior therapy with mitotane is allowed) for adrenocortical carcinoma 3. Renal insufficiency (serum creatinine more than or equal to 2 mg/dl or creatinine clearance less than or equal to 50 ml/min) 4. Hepatic insufficiency (serum bilirubin more than or equal to two times the institutional upper limit of normal range and/or serum transaminases more than or equal to three times the institutional upper limit of normal range; exception: in patients on mitotane transaminase levels up to five times the institutional upper limit of normal range are acceptable) 5. Pregnancy or breast feeding 6. Known hypersensitivity to any drug included in the treatment protocol 7. Presence of active infection 8. Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion 9. Decompensated heart failure (ejection fraction less than 50%), myocardial infarction or revascularization procedure during the last six months, unstable angina pectoris, and uncontrolled cardiac arrhythmia 10. Current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma 11. Prisoners |
Date of first enrolment | 01/07/2004 |
Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Australia
- France
- Germany
- Italy
- Netherlands
- Sweden
- United States of America
Study participating centre
University Hospital Uppsala
Uppsala
75185
Sweden
75185
Sweden
Sponsor information
Collaborative group for Adrenocortical Carcinoma Therapy (CO-ACT) (Germany)
Research organisation
Research organisation
c/o University Hospital Uppsala (Sweden) and University Hospital Wuerzburg (Germany)
Josef-Schneider-Str. 2
Wuerzburg
97080
Germany
Phone | +49 (0) 931 201 36507 |
---|---|
Fassnacht_m@medizin.uni-wuerzburg.de | |
Website | http://www.firm-act.org |
Funders
Funder type
Hospital/treatment centre
Investigator funded trial (CO-ACT)
No information available
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 |