Clinical trial NCT01286766: Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma
Official title: A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: unresectable
locally advanced
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.

Detailed description: Treatment scheme

* Screening period: D-21 to D1 (treatment day)
* Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.
* Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)
* Tumor response is assessed every 2 cycles (6 weeks)
* Treatment is repeated until,.

  * 4 cycles
  * progressive disease
  * unacceptable toxicity
  * patient's withdrawal
* Gastric surgery should be performed within 4\~6 weeks of the last dose of chemotherapy
* Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
* Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.
* Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.
* Follow up for survival is repeated every 3 months for 2 years

Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months

Eligibility criteria: Inclusion Criteria:

* Histologically/cytologically confirmed gastric adenocarcinoma
* Age 18 to 70 years old
* ECOG performance Status 0\~1
* Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA\~IV), M0, P0, H0, CY0
* No pretreatment (radiotherapy or chemotherapy) for gastric cancer
* Adequate organ function

  * Hb ≥ 9.0 g/dL
  * WBC ≥ 4,000/µL
  * ANC ≥ 2,000/µL (\*ANC = Neutrophil segs ＋ Neutrophil bands)
  * Platelet ≥ 100 × 103/ µL
  * Total bilirubin: ≤ 1.5 × UNL
  * CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)
  * AST/ALT, ALP: ≤ 2.5 × UNL
* Written informed consent

Exclusion Criteria:

* Distant metastasis on diagnosis
* cT1-2
* Cancer of gastroesophageal junction (GEJ)
* Poor oral intake or absorption deficiency syndrome
* Gastric outlet obstruction, perforation or bleeding
* Medically uncontrollable chronic illness or infection
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* History of clinically significant cardiac disease
* Past or concurrent history of neoplasm last \< 5 year other than gastric cancer
* Prior gastrectomized patients
* Concomitant administration of any other experimental drug under investigation
* Peripheral neuropathy ≥ NCI-CTC grade 2

Primary outcomes:
measure: RECIST(Response Evaluation Criteria in Solid Tumors)
timeFrame: written in the description part below
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: