Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

Stomach Neoplasms Clinical Trial

— SEED  

Official title:

Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02177552
• Other study ID #: 01052014
• Secondary ID: 2014-000127-24
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: November 2019

Study information

• Verified date: February 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: November 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Key Inclusion Criteria:

• Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach

• Men or women less than 80 years of age

• Performance status 0 or 1

• Life expectancy >12 weeks

• Adequate organ-function

• Written informed consent

Key Exclusion Criteria:

• Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months

• Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach

• Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry

• Prior cumulative dose of >300 mg/m2 of epirubicin

• Grade = 2 side-effects from previous chemotherapy

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Carboplatin

• Docetaxel

• Capecitabine

• Epirubicin

• Oxaliplatin

Locations

Country	Name	City	State
Denmark	Finsen Center, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of cmet by immunohistochemistry	Analysis of archived tumour tissue (primary biopsy, previous surgical resection specimen if available) and metastatic tumour tissue for consenting subjects.	Three and a half years
Primary	The proportion of participants alive one year after randomisation		Three and a half years
Secondary	Time to progression or death due to any cause		Three and a half years
Secondary	Number of participants with grade 3 and 4 toxicities caused by treatments		Day 1 of every cycle and 30 days after completion of treatment
Secondary	Time until death due to any cause		Three and a half years
Secondary	Changes in quality-of-life		Three and a half years
Secondary	The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced		Five years
Secondary	Registration of further lines of therapy		Five years