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A study to investigate the feasibility of chemotherapy prior to surgery and protocolized surgery in resectable stomach cancer.


- candidate number8030
- NTR NumberNTR2306
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2010
- Secondary IDsNL20764.028.07 METOPP/CCMO
- Public TitleA study to investigate the feasibility of chemotherapy prior to surgery and protocolized surgery in resectable stomach cancer.
- Scientific TitleA Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer. An IKZ-based phase II feasibility study.
- ACRONYMDoCCS
- hypothesisAssessment of feasibility of neoadjuvant chemotherapy consisting of docetaxel, cisplatin and capecitabine in resectable localized gastric cancer (stage Ib-IVa) and the introduction of the D1extra-lymphadenectomy as the standardized surgical treatment modality.
- Healt Condition(s) or Problem(s) studiedGastric carcinoma
- Inclusion criteria1. Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma;
2. Siewert 2 and 3;
3. WHO 1 or ASA 1 or 2;
4. Age 18 years and older;
5. No prior radio- or chemotherapy conflicting with the treatment of gastric cancer;
6. Haematology/Renal function/Liver function within designated range;
7. Patientís consent form obtained, signed and dated before beginning specific protocol procedures;
8. Expected patientís compliance with treatment, management of toxicity and scheduled follow-up.
- Exclusion criteria1. Inoperable patients;
2. Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer;
3. Other current serious illness or medical conditions:
A. Severe cardiac illness (NYHA class III-IV);
B. Significant neurologic or psychiatric disorders;
C. Uncontrolled infections;
D. Active DIC;
E. Other serious underlying medical conditions that could impair the ability of the patient to participate in the study.
4. Known hypersensitivity to Docetaxel/Taxotere (or any drug formulated with Polysorbate-80), or Cisplatin or Capecitabine/Xeloda or 5-FU;
5. Definite contraindications for the use of corticosteroids;
6. Use of immunosuppressive or antiviral drugs;
7. Any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period;
8. Pregnant or lactating women;
9. Patients with reproductive potential not implementing adequate contraceptive measures.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 11-jun-2008
- planned closingdate1-jun-2011
- Target number of participants50
- InterventionsNeo-adjuvant chemotherapy consisting of 4 courses of docetaxel/taxotere, cisplatin and capecitabine/xeloda, followed by gastric resection and a D1-extra lymphadenectomy. The D1-extra-lymphadenectomy consists of resecting lymph node stations 3-9 according to the Japanese classification of gastric carcinoma, and depending on location of tumour, an additional resection of lymph node station 1, 2, 10 and 12a.
- Primary outcome1. Feasibility and toxicity/safety profile of the combination of 4 courses of docetaxel/Taxotere, cisplatin and capecitabine/Xeloda as neoadjuvant chemotherapy in resectable localized or locally advanced gastric cancer;
2. Assessment of neoadjuvant chemotherapy-induced tumour response with CT or optional PET-CT;
3. Implementation of a D1extra-resection implementation as protocolized surgery in resectable gastric cancer and rate of successful implementation;
4. Assessment of quality of life after treatment with neo-adjuvant chemotherapy and surgery in local or locally advanced gastric carcinoma.
- Secondary outcome1. Determination of chemotherapy-induced pathological response according to WHO criteria for measurement of response;
2. Determination of pathological resection (R0/R1/R2).
- Timepoints1. Feasibility and toxicity/safety proflie of chemotherapy: during and after each course of chemotherapy;
2. Assessment of chemotherapy induced tumour response:
A. With CT: between day 76 and 90;
B. With PET-CT: after course 1 between day 14 and 21 and after course 4 between day 76 and 90;
3. Implementation of D1extra-resection and rate of successful implementation: during and after surgery;
4. Assessment of quality of life: before treatment, after completing neoadjuvant chemotherapy, and 6 weeks, 3 and 12 months after surgery;
5. Determination of chemotherapy induced pathological response: during pathological exam;
6. Determination of pathological resection: during pathological exam.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESAIOS A.E. Dassen
- CONTACT for SCIENTIFIC QUERIESAIOS A.E. Dassen
- Sponsor/Initiator Jeroen Bosch Hospital
- Funding
(Source(s) of Monetary or Material Support)
Jeroen Bosch Hospital
- PublicationsN/A
- Brief summaryThe DoCCS-study is a multicentre, phase II study to investigate the feasibility of neoadjuvant chemotherapy consisting of docetaxel/taxotere, cisplatin and capecitabine/xeloda, followed by gastric resection and D1extra-lymphadenectomy in resectable gastric cancer.
This trial is conducted in the Netherlands.
- Main changes (audit trail)
- RECORD28-apr-2010 - 9-mei-2010


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