Trials Sponsors Conditions Drugs Pricing

Conditions

Gastroesophageal Junction Neoplasms Stomach Neoplasms

Keywords

Stomach NeoplasmsGastroesophageal Junction Neoplasmsgastric cancercancer of the gastroesophageal junction

Outcome Measures

Primary Outcomes (1)

Frequency of pT3/T4 categories after surgery
after 9 weeks treatment

Secondary Outcomes (1)

Frequencies of pN2/N3 categories after surgery
After 9 weeks treatment

Study Arms (2)

Arm 1: ECX + Panitumumab

EXPERIMENTAL

Drug: Epirubicin, Cisplatin, Capecitabine, Panitumumab

Arm 2: EXC alone

ACTIVE COMPARATOR

Drug: Epirubicin, Cisplatin, Capecitabine

Interventions

Epirubicin, Cisplatin, Capecitabine, PanitumumabDrug

Epirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle; Panitumumab: 9 mg/kg bodyweight, administered IV by an infusion pump through a peripheral line or catheter over 60 min +-15 min on day 1 of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.

Also known as: Xeloda®

Arm 1: ECX + Panitumumab

Epirubicin, Cisplatin, CapecitabineDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Epirubicin, Cisplatin, Capecitabine, Panitumumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
Epirubicin, Cisplatin, Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Competent to comprehend, sign, and date an IEC-approved informed consent form, written informed consent.
Of either gender and aged 18 years or more.

Sponsors & Collaborators

WiSP Wissenschaftlicher Service Pharma GmbH
Othercollaborator
AIO-Studien-gGmbH
Otherlead
Amgen

Study Sites (1)

AIO-Studien gGmbH

Berlin, 10623, Germany

Related Publications (6)

Becker K, Mueller JD, Schulmacher C, Ott K, Fink U, Busch R, Bottcher K, Siewert JR, Hofler H. Histomorphology and grading of regression in gastric carcinoma treated with neoadjuvant chemotherapy. Cancer. 2003 Oct 1;98(7):1521-30. doi: 10.1002/cncr.11660.
PMID: 14508841BACKGROUND
Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
PMID: 16822992BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

EpirubicinCisplatinCapecitabinePanitumumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin

Study Officials

M. Stahl, Prof. Dr. med.
Klinken Essen-Mitte Evang. Huyssens-Stiftung
PRINCIPAL INVESTIGATOR

Enrollment

171 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 28, 2010

First Posted

November 4, 2010

Study Start

October 2010

Actual (reported)

You may not qualify if:

Any metastatic disease.
Other malignant tumours less than five years old. Exceptions include basocellular carcinoma, in situ cancer of the cervix of the uterus, or any curatively-treated other malignancies without evidence of disease for more than five years.
Significant ascites or pleural effusion.
Prior anti-EGFr antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
Prior chemotherapy, radiotherapy or antibody therapy for gastric cancer or cancer of the gastro-oesophageal junction.
Concomitant therapy with sorivudine or analogue compounds.
Known previous or ongoing abuse of narcotic drug, other medication or alcohol.
Significant cardiovascular disease including New York Heart Association (NYHA) grade II or greater congestive heart failure, peripheral arterial occlusive disease stage II or greater, symptomatic coronary heart disease, insufficiently treated arterial hypertension, unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
History or evidence upon physical examination of CNS disease unless adequately treated, seizure not controlled with standard medical therapy, or history of stroke.
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.
Pre-existing polyneuropathy grade \>1 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), except for loss of tendon reflex as the only symptom.
Treatment for systemic infection within 14 days before initiating study treatment.
Active inflammatory bowel disease, serious gastric ulceration or other bowel disease causing chronic diarrhoea (defined as \> 4 loose stools per day).
Suspected or known dihydropyrimidine dehydrogenase deficiency (DPD).
Thrombosis or severe bleeding within six months prior to entry into the study (except for bleeding of the tumour before its surgical resection), evidence of bleeding diathesis or coagulopathy, or current or recent (within 10 days prior to initiation of study treatment) use of full-dose oral or parenteral anticoagulants for therapeutic purposes.
+11 more criteria

ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Arm 1: ECX + Panitumumab

Arm 2: EXC alone

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Arm 1: ECX + Panitumumab

Arm 2: EXC alone

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations