Gastric CancerPhase 2DCXAIOCHARITENCT00865982
Study to Evaluate Safety and Efficacy of Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine (DCX) in Patients With Gastro-esophageal Cancer
A Phase 2 study testing Docetaxel, Cisplatin, Capecitabine in people with Gastric Cancer and Esophageal Cancer, run by Charite University, Berlin, Germany at 9 sites in Germany.
Trial summary
In this study, patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX (Docetaxel, Cisplatin, Capecitabine) followed by surgical resection… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer
- What is being tested?
- Docetaxel, Cisplatin, Capecitabine
- How many people
- 50 participants
- Where
- 9 sitesGermany
- Study dates
- Sep 2008to Sep 2015
- Phase
- Phase 2
- 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
- Signed and dated consent
- Age between minimum 18 and maximum 75 years
- Primary diagnosis of histologically proven adenocarcinoma of the stomach, the gastro-esophageal junction or an adenocarcinoma of the lower third of the esophagus
- Stage II-III, which is in TNM-staging: T3-4, N0-3, M0 or T2, N1-3, M0 or T1, N2, M0. (equivalent to clinical staging uT3-4NXM0, uT1-2N+M0)
- Intended curative resection according to evaluation of an experienced surgeon
- Karnofsky-performance-index > 70%
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- Negative pregnancy blood test at screening but not earlier than 72 hours prior to start of chemotherapy for women with child bearing potential
- Adequate haematologic function and liver and renal function: neutrophils > 1,5 x 109/L; thrombocytes > 100 x 109/L; haemoglobin > 10 g/dl, creatinine clearance > 60 ml/min (calculated according to Cockroft and Gault), total bilirubin < 1,0 x UNL; AST and ALT < 1,5 x UNL, AP < 2,5 x UNL
- Complete staging within 3 weeks prior to start of treatment (CT-scan of thorax and abdomen, endosonography, gastroscopy)
- Ability to keep appointments and follow the study protocol
- By CT-scan, endoscopy or endosonography measurable or evaluable disease
Who cannot join
- Former therapy of gastro-esophageal cancer (operation, chemo- or radiotherapy)
- Diagnosis of another cancer in the last 5 years prior to study entry which has not been cured by operation only (exception in-situ-carcinoma of the cervix or cured non-melanomatose skin cancer)
- Known dihydropyrimidine-dehydrogenase (DPD)-deficiency
- Known contraindication to the planned chemotherapeutics
- Presence of distant metastases
- Anamnestic known serious disease or other concomitant diseases that affect participation in this study, such as:
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- Instable cardiac disease: symptomatic heart failure, symptomatic coronary artery disease, ventricular cardiac arrhythmia not well controlled with medication, myocardial infarction or resuscitation within 6 month before study
- Active infection necessitating systemic therapy or uncontrolled infection
- Interstitial lung diseases (for example: pneumonitis or fibrosis of the lung) and indication for interstitial lung disease in chest x-ray or CT-scan respectively
- Active inflammatory bowel disease or other bowel diseases which provoke chronic diarrhea (defined as > 4 bowel movements per day)
- Neurological or psychiatric disease including dementia, epilepsy or untreated, symptomatic brain metastases
- Limited hearing ability
- Presence of upper GI obstruction, leading to inability to swallow ground tablets
- Presence of acute or chronic systemic infection
- Presence of a bowel obstruction within the last 30 days
- Pregnant or lactating women or women with child bearing potential and men without adequate contraception (high effective contraception, defined as Pearl Index < 1) like birth control pill, hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), realized sterilization or sexual abstinence during the study and at least for 3 months after the last infusion
- Any other situation which may lead to an unacceptable high risk for the patient, when he participates in the study
- Parallel treatment in another clinical study or prior participation in this study
- Treatment with any other therapy against the tumor or any parallel radiation
- Parallel treatment with Sorivudine or an chemically related substance like for example Brivudin
- Symptomatic peripheral neuropathy NCI-CTCAE degree > 2
- Intolerance to the study medication or their galencic ingredients or against 5-FU
- Detention in a psychiatric unit or imprisonment (AMG §40 Abs. 1 Nr. 4)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
HELIOS-Klinik Bad Saarow
Bad Saarow
Klinik für Hämatologie, Onkologie und Tumorimmunologie, Charite Campus Buch
Berlin
Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite Campus Benjamin-Franklin
Berlin
Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charite Campus Virchow Klinikum
Berlin
Klinik für Innere Medizin Abteilung Hämatologie/Onkologie, Städtisches Klinikum Dessau
Dessau
Universitätsklinik und Poliklinik für Innere Medizin IV, Martin Luther Universität Halle-Wittenberg
Halle
II. Medizinische Klinik und Poliklinik, Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel
Internistische Onkologie/ Hämatologie, Städtisches Krankenhaus St. Georg
Leipzig
3. Medizinische Klinik, Onkologisches Zentrum, Universitätsklinikum Mannheim
Mannheim
About this study
Official title: Multicenter, Open Lable Phase II Study to Evaluate the Safety and Efficacy of a Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine in Patients With Gastric Adenocarcinoma, Adenocarcinoma of the Gastro-esophageal Junction or the Distal Esophagus
In this study, patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX (Docetaxel, Cisplatin, Capecitabine) followed by surgical resection, followed by 3 postoperative cycles of DCX.
Read the detailed description
Perioperative chemotherapy has been shown to significantly improve the R0 resection rate, the disease free survival and the overall survival in patients with adenocarcinoma of the distal esophagus, the gastro-esophageal junction and the stomach. Therefore perioperative chemotherapy is the new therapeutic standard (Cunningham NEJM 2006, MRC, Lancet 2002, Boige ASCO 2007). The best evaluated regime is the combination of Epirubicin, Cisplatin and 5-FU (ECF) (Cunningham, NEJM 2007). Cisplatin and 5-FU seem to be the most important components forming the backbone of this regime (Boige ASCO 2007).
Docetaxel is a new and highly active agent in gastric cancer. In a randomized phase II study the dual combination of Docetaxel and 5-FU seemed to show similar activity as ECF, administered as first line palliative treatment (Thuss-Patience, JCO, 2005). The three drug combination Docetaxel, Cisplatin, 5-FU has significantly superior efficacy than a combination of Cisplatin und 5-FU, superior quality of life and significantly superior overall survival (Van Cutsem, JCO 2007).
It has been shown that Capecitabine the oral prodrug of 5-FU is similarly active as 5-FU and can replace intravenous 5-FU in combination with Cisplatin in the treatment of gastric cancer. Capecitabine therefore is FDA approved for gastric cancer (Cunningham, ASCO 2006, Kang ASCO 2006).
It seems reasonable to optimize perioperative chemotherapy by including modern chemotherapeutics. The old standard ECF may be improved by integrating Docetaxel und Capecitabine. By adding Docetaxel to the Cisplatin / flouropyrimidin backbone the efficacy of the regime may be improved. The replacement of 5-FU by Capecitabine may improve patients´ convenience and possibly effectiveness of the combination. Therefore the 3 drug combination of Docetaxel, Cisplatin, Capecitabin (DCX) seems to be a highly promising regime regarding effectiveness and convenience.
In this study patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX followed by surgical resection, followed by 3 postoperative cycles of DCX.
The first application of study medication has to be within 21 days of tumour assessment. There will be 3 preoperative cycles every 3 weeks. The experimental perioperative regime evaluated in this study will be Docetaxel/Cisplatin/Capecitabine DCX (75/ 60/ 1875 mg/m2).The operation will be performed 3 to 6 weeks after the end of the third preoperative chemotherapy cycle (counted from day 21 of cycle 3).
Postoperative chemotherapy will start within 6 - 12 weeks after the operation. 3 weeks after the end of the last chemotherapy the final investigation (end of study visit) will be done.
- Conditions
- Gastric Cancer, Esophageal Cancer
- Being tested
- Docetaxel, Cisplatin, Capecitabine
- Keywords
- adenocarcinoma of the stomach, gastro-esophageal junction or distal esophagus, gastric cancer, esophageal cancer, gastro-esophageal junction, docetaxel, capecitabine, cisplatin, perioperative chemotherapy
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, Cisplatin, CapecitabineDrug
3 preoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks
followed by resection
and 3 postoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
R0-resection rate
Measured: After 3 cycles of preoperative chemotherapy (3 month)
Secondary outcomes (10)
Remission rate according to diagnostic imaging techniques
Measured: After 3 cycles of preoperative chemotherapy (3 month)
Pathological remission rate
Measured: After 3 cycles of preoperative chemotherapy (3 month)
Operative and postoperative complication rate
Measured: Within 30 days after surgery
Resectability rate
Measured: After 3 cycles of preoperative chemotherapy (3 month)
Rate of local recurrences and metastasis
Toxicity
30-day mortality
Measured: After date of surgery
Overall survival
Overall survival rate
Measured: 1,2,3 and 5 years
Event free survival rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
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 Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Sanofi
- Investigators
- Peter Thuss-Patience, Dr. med., Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865982
- Sponsor's protocol ID
- Eudract-CT-2008-001849-26
- Acronym
- DCXAIOCHARITE
- Status last verified
- Aug 2011
- First submitted
- 19 Mar 2009
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thuss-Patience PC, Hofheinz RD, Arnold D, Florschutz A, Daum S, Kretzschmar A, Mantovani-Loffler L, Bichev D, Breithaupt K, Kneba M, Schumacher G, Glanemann M, Schlattmann P, Reichardt P, Gahn B. Perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in gastro-oesophageal adenocarcinoma: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)dagger. Ann Oncol. 2012 Nov;23(11):2827-2834. doi: 10.1093/annonc/mds129. Epub 2012 Jun 24.
PubMed 22734012
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open Lable Phase II Study to Evaluate the Safety and Efficacy of a Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine in Patients With Gastric Adenocarcinoma, Adenocarcinoma of the Gastro-esophageal Junction or the Distal Esophagus
- ClinicalTrials.gov ID
- NCT00865982
- Acronym / sponsor ID
- DCXAIOCHARITE / Eudract-CT-2008-001849-26
- Conditions
- Gastric Cancer, Esophageal Cancer
- Keywords
- adenocarcinoma of the stomach, gastro-esophageal junction or distal esophagus, gastric cancer, esophageal cancer, gastro-esophageal junction, docetaxel, capecitabine, cisplatin, perioperative chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Sanofi
- Study start
- Sep 2008
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 20 Mar 2009 (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.
In this study, patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX (Docetaxel, Cisplatin, Capecitabine) followed by surgical resection, followed by 3 postoperative cycles of DCX.
Detailed description
Perioperative chemotherapy has been shown to significantly improve the R0 resection rate, the disease free survival and the overall survival in patients with adenocarcinoma of the distal esophagus, the gastro-esophageal junction and the stomach. Therefore perioperative chemotherapy is the new therapeutic standard (Cunningham NEJM 2006, MRC, Lancet 2002, Boige ASCO 2007). The best evaluated regime is the combination of Epirubicin, Cisplatin and 5-FU (ECF) (Cunningham, NEJM 2007). Cisplatin and 5-FU seem to be the most important components forming the backbone of this regime (Boige ASCO 2007).
Docetaxel is a new and highly active agent in gastric cancer. In a randomized phase II study the dual combination of Docetaxel and 5-FU seemed to show similar activity as ECF, administered as first line palliative treatment (Thuss-Patience, JCO, 2005). The three drug combination Docetaxel, Cisplatin, 5-FU has significantly superior efficacy than a combination of Cisplatin und 5-FU, superior quality of life and significantly superior overall survival (Van Cutsem, JCO 2007).
It has been shown that Capecitabine the oral prodrug of 5-FU is similarly active as 5-FU and can replace intravenous 5-FU in combination with Cisplatin in the treatment of gastric cancer. Capecitabine therefore is FDA approved for gastric cancer (Cunningham, ASCO 2006, Kang ASCO 2006).
It seems reasonable to optimize perioperative chemotherapy by including modern chemotherapeutics. The old standard ECF may be improved by integrating Docetaxel und Capecitabine. By adding Docetaxel to the Cisplatin / flouropyrimidin backbone the efficacy of the regime may be improved. The replacement of 5-FU by Capecitabine may improve patients´ convenience and possibly effectiveness of the combination. Therefore the 3 drug combination of Docetaxel, Cisplatin, Capecitabin (DCX) seems to be a highly promising regime regarding effectiveness and convenience.
In this study patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX followed by surgical resection, followed by 3 postoperative cycles of DCX.
The first application of study medication has to be within 21 days of tumour assessment. There will be 3 preoperative cycles every 3 weeks. The experimental perioperative regime evaluated in this study will be Docetaxel/Cisplatin/Capecitabine DCX (75/ 60/ 1875 mg/m2).The operation will be performed 3 to 6 weeks after the end of the third preoperative chemotherapy cycle (counted from day 21 of cycle 3).
Postoperative chemotherapy will start within 6 - 12 weeks after the operation. 3 weeks after the end of the last chemotherapy the final investigation (end of study visit) will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated consent
- Age between minimum 18 and maximum 75 years
- Primary diagnosis of histologically proven adenocarcinoma of the stomach, the gastro-esophageal junction or an adenocarcinoma of the lower third of the esophagus
- Stage II-III, which is in TNM-staging: T3-4, N0-3, M0 or T2, N1-3, M0 or T1, N2, M0. (equivalent to clinical staging uT3-4NXM0, uT1-2N+M0)
- Intended curative resection according to evaluation of an experienced surgeon
Key exclusion criteria (23 listed)
- Former therapy of gastro-esophageal cancer (operation, chemo- or radiotherapy)
- Diagnosis of another cancer in the last 5 years prior to study entry which has not been cured by operation only (exception in-situ-carcinoma of the cervix or cured non-melanomatose skin cancer)
- Known dihydropyrimidine-dehydrogenase (DPD)-deficiency
- Known contraindication to the planned chemotherapeutics
- Presence of distant metastases
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 |
|---|---|---|
| Docetaxel, Cisplatin, Capecitabine3 preoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks followed by resection and 3 postoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks. | Drug | – |
Primary outcome
R0-resection rate
Time frame: After 3 cycles of preoperative chemotherapy (3 month)
10 secondary outcomes
Remission rate according to diagnostic imaging techniques
Time frame: After 3 cycles of preoperative chemotherapy (3 month)
Pathological remission rate
Time frame: After 3 cycles of preoperative chemotherapy (3 month)
Operative and postoperative complication rate
Time frame: Within 30 days after surgery
Resectability rate
Time frame: After 3 cycles of preoperative chemotherapy (3 month)
Rate of local recurrences and metastasis
Toxicity
30-day mortality
Time frame: After date of surgery
Overall survival
Overall survival rate
Time frame: 1,2,3 and 5 years
Event free survival rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Derived from this study: PubMed 22734012Thuss-Patience PC, Hofheinz RD, Arnold D, Florschutz A, Daum S, Kretzschmar A, Mantovani-Loffler L, Bichev D, Breithaupt K, Kneba M, Schumacher G, Glanemann M, Schlattmann P, Reichardt P, Gahn B. Perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in gastro-oesophageal adenocarcinoma: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)dagger. Ann Oncol. 2012 Nov;23(11):2827-2834. doi: 10.1093/annonc/mds129. Epub 2012 Jun 24.
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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.
Peter Thuss-Patience, Dr. med. study chair
Charite University, Berlin, Germany
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Cisplatin, Capecitabine in people with Gastric Cancer and Esophageal Cancer, run by Charite University, Berlin, Germany at 9 sites 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 11 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
R0-resection rate (time frame: After 3 cycles of preoperative chemotherapy (3 month)). 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 NCT00865982, 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 5 Aug 2011.