Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer

Phase 3

Completed

• Conditions: Gastric Cancer; Metastases
• Interventions: Drug: FOLFIRI; Drug: DP

• Registration Number: NCT00313872
• Lead Sponsor: Samsung Medical Center

Brief Summary

To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients.

Detailed Description

Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. A recent phase III trial comparing docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a significant superiority of DCF in terms of survival, time-to-progression, and response rate. However, because DCF regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. Thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Primary Completion: 2009-06
• Study Completion: 2010-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Histologically confirmed metastatic adenocarcinoma of the stomach
2. Age ≥ 18
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
4. Life expectancy of at least 3 months
5. Adequate renal, liver, bone marrow functions
6. Adjuvant chemotherapy more than 12 months from the date of study entry
7. Written informed consent

Exclusion Criteria

1. Active infection requiring antibiotics
2. Pregnant, lactating women
3. Brain metastasis
4. Systemic illness not appropriate for chemotherapy
5. Radiotherapy within 2 weeks before the study entry
6. Allergy to drugs used in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFIRI	FOLFIRI	-
DP	DP	D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr, D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan

Primary Outcome Measures

Name	Time	Method
Second progress-free survival	2years

Secondary Outcome Measures

Name	Time	Method
Toxicity, overall survival	2years

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of