Condition category
Cancer
Date applied
08/12/2008
Date assigned
05/02/2009
Last edited
05/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wilfried Troger

ORCID ID

Contact details

Zechenweg 6
Freiburg
79111
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

29/07

Study information

Scientific title

Mistletoe therapy for advanced pancreatic cancer: a group sequential, randomised, phase III, open label study

Acronym

MAPAC

Study hypothesis

Primary hypothesis:
Patients receiving Iscador Qu Spzial (IQuS) will show a higher overall survival rate.

Secondary hypothesis:
Patients receiving IQuS will show improved (better) quality of life.

Ethics approval

Ethics Committee of the Clinical Centres of Serbia gave approval on the 4th March 2008 (ref: 60/6)

Study design

Group sequential randomised open label phase III study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pancreatic cancer stage III and IV

Intervention

Subcutaneous (s.c.) injection of an extract of Viscum album (L.), the generic name of the investigational product is "Iscador Qu Spzial".

The dosage begins for all patients in the verum group with an initial phase: 2 x 0.01 mg, 2 x 0.1 mg, 5 x 1 mg, 5 x 5 mg, and 10 mg. For the following maintenance phase, the highest dosage of 10 mg is recommended. During the initial and the maintenance phase the dosage will be modified according to the patients tolerability. The investigational product is injected subcutaneously 3 times weekly. Patients in the “mistletoe” group will administer the investigational product for 12 months. All patients of the study are followed up 12 months after inclusion into the study.

Intervention type

Drug

Phase

Phase III

Drug names

Iscador Qu Spzial (IQuS)

Primary outcome measures

Overall survival rate, followed up after inclusion at months 1, 2, 3, 6, 9, and 12.

Secondary outcome measures

Quality of life questionnaire, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30), followed up after inclusion at months 1, 2, 3, 6, 9, and 12.

Overall trial start date

01/01/2009

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, and, if easily accessible, histo- or cytologically confirmed
2. Aged greater than or equal to 18 years at study enrolment, either sex
3. Written informed consent must be given voluntarily
4. Patients not eligible for gemcitabine
5. Leucocytes greater than 3000/mm^3
6. Thrombocytes greater than 100,000/mm^3
7. Serum creatinine less than 2 mg %
8. Serum glutamic oxaloacetic transaminase (SGOT) less than 3.5-fold upper institutional limit (liver metastasis: five-fold upper institutional limit)
9. Serum glutamic pyruvic transaminase (SGPT) less than 3.5-fold upper institutional limit (liver metastasis: five-fold upper institutional limit)
10. Adequate negative pregnancy test and adequate contraception (where appropriate)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

434

Participant exclusion criteria

1. Pregnancy or breastfeeding
2. Terminally ill patients (life expectancy less than 4 weeks)
3. Significant weight loss (less than 20% body weight in the preceding 6 weeks)
4. Current use of immunostimulant or immuno-suppressive agents except therapeuticals within the routinely administered standard therapy "best supportive care"
5. Current use of investigational agents or participation in a clinical study during the last 4 weeks
6. Clinically significant unrelated systemic illness
7. Co-morbidity with one of the following:
7.1. Diabetes mellitus
7.2. Active tuberculosis
7.3. Active thyroid hyperfunction
7.4. Cancer
7.5. Human immunodeficiency virus (HIV)-infection/acquired immune deficiency syndrome (AIDS)
7.6. Other severe systemic diseases as cardiac insufficiency, parasitosis or Crohn's disease
7.7. Acute inflammatory diseases with body temperature greater than 38°C
8. Drug abuse, alcohol abuse, methadone treatment
9. Known hypersensitivity to mistletoe-containing products
10. Second primary malignancy
11. Known brain metastasis

Recruitment start date

01/01/2009

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Serbia

Trial participating centre

Zechenweg 6
Freiburg
79111
Germany

Sponsor information

Organisation

Society for Cancer Research (Verein fuer Krebsforschung) (Switzerland)

Sponsor details

Kirschweg 9
Arlesheim
4144
Switzerland

Sponsor type

Research organisation

Website

http://www.hiscia.ch/

Funders

Funder type

Research organisation

Funder name

Society for Cancer Research (Verein fuer Krebsforschung) (Switzerland)

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