Contact information
Type
Scientific
Primary contact
Prof Britt Skogseid
ORCID ID
Contact details
University Hospital Uppsala
Entrance 40
5th floor
Uppsala
75185
Sweden
+46 186113768
britt.skogseid@medsci.uu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CO-ACT-001
Study information
Scientific title
Acronym
FIRM-ACT
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Etoposide, Doxorubicin, Cisplatin and Mitotane versus Streptozotocin and Mitotane
Primary outcome measures
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 trial start date
01/07/2004
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/07/2004
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Australia, France, Germany, Italy, Netherlands, Sweden, United States of America
Trial participating centre
University Hospital Uppsala
Uppsala
75185
Sweden
Sponsor information
Organisation
Collaborative group for Adrenocortical Carcinoma Therapy (CO-ACT) (Germany)
Sponsor details
c/o University Hospital Uppsala (Sweden) and University Hospital Wuerzburg (Germany)
Josef-Schneider-Str. 2
Wuerzburg
97080
Germany
+49 (0) 931 201 36507
Fassnacht_m@medizin.uni-wuerzburg.de
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Investigator funded trial (CO-ACT)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary