Condition category
Cancer
Date applied
22/08/2005
Date assigned
16/09/2005
Last edited
20/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.firm-act.org

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. Patient’s 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

http://www.firm-act.org

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

Publication citations

Additional files

Editorial Notes