Stomach NeoplasmPhase 3NCT00144378
Irinotecan Versus Only Best Supportive Care for Gastric Cancer
A Phase 3 study testing Irinotecan in people with Stomach Neoplasm and Neoplasm Metastasis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasm, Neoplasm Metastasis
- What is being tested?
- Irinotecan
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2002to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
- Patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy
- Patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to WHO criteria
- Age 18 and 75 years
- Sufficient liver function, defined as serum-bilirubin <1,5 mg/dl (1,5 upper normal limit), ALT und AST < 3x upper normal limit
- Sufficient renal function, defined as serum creatinine < 1,25 x upper normal limit or creatinine clearance >60ml/min calculated according to Crockroft-Gault
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- Contraction for patient with reproductive potential
- Karnofsky-Index >60%
- Measurable or evaluable tumor manifestation
Who cannot join
- Tumor progression later than 6 months after termination of first-line chemotherapy
- KI 50% or less
- Patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed)
- Prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix
- Uncontrolled infection
- CNS metastases
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- Other severe medical illness
- Prior major surgery less than 2 weeks ago
- Parallel treatment with another experimental therapy
- Parallel treatment with another therapy aiming at tumor reduction
- Chronic diarrhea, subileus
- Chronic inflammatory bowel disease or intestinal obstruction
- Pretreatment with irinotecan
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,
Berlin
About this study
Official title: Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary.
Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.
Read the detailed description
Metastatic gastric cancer, progressive disease after one palliative chemotherapy
Arm A:
Irinotecan 250/350 mg/m2 q3w
- Cycle:250mg/m2/ 30min
- Cycle:If no toxicity>2° CTC, nor Leuko-thrombopenia>3° occured, dose is increased to 350mg/m2 Arm B. Best supportive care
- Conditions
- Stomach Neoplasm, Neoplasm Metastasis
- Being tested
- Irinotecan
- Keywords
- gastric cancer, metastatic, irinotecan
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
median survival
Secondary outcomes (1)
quality of life, response rates, time to tumor progression, toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- P Reichardt MD PhD, Principal investigator, Charité, University,Campus Virchow Klinikum, Dep. of Hematology and Oncology,BerlinPC Thuss-Patience MD PhD, Principal investigator, Charité, University,Campus Virchow Klinikum,Dep. of Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144378
- Sponsor's protocol ID
- irinotecan vs. bsc
- Status last verified
- Apr 2007
- First submitted
- 2 Sep 2005
- Last updated
- 18 Apr 2007
- Results posted
- No
Publications
Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.
PubMed 21742485
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00144378
- Acronym / sponsor ID
- irinotecan vs. bsc
- Conditions
- Stomach Neoplasm, Neoplasm Metastasis
- Keywords
- gastric cancer, metastatic, irinotecan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2002
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary.
Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.
Detailed description
Metastatic gastric cancer, progressive disease after one palliative chemotherapy
Arm A:
Irinotecan 250/350 mg/m2 q3w
- Cycle:250mg/m2/ 30min
- Cycle:If no toxicity>2° CTC, nor Leuko-thrombopenia>3° occured, dose is increased to 350mg/m2 Arm B. Best supportive care
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
- Patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy
- Patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to WHO criteria
- Age 18 and 75 years
- Sufficient liver function, defined as serum-bilirubin <1,5 mg/dl (1,5 upper normal limit), ALT und AST < 3x upper normal limit
Key exclusion criteria (13 listed)
- Tumor progression later than 6 months after termination of first-line chemotherapy
- KI 50% or less
- Patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed)
- Prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix
- Uncontrolled infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan | Drug | – |
Primary outcome
median survival
1 secondary outcome
quality of life, response rates, time to tumor progression, toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2007.
- Derived from this study: PubMed 21742485Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P Reichardt MD PhD principal investigator
Charité, University,Campus Virchow Klinikum, Dep. of Hematology and Oncology,Berlin
PC Thuss-Patience MD PhD principal investigator
Charité, University,Campus Virchow Klinikum,Dep. of Hematology and Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irinotecan in people with Stomach Neoplasm and Neoplasm Metastasis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2007.