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Completed

NCT Number: NCT02114359

Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer

The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • .Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
  • 70 yrs or older
  • Eastern Cooperative Oncology Group 0-2
  • Measurable or evaluable disease
  • Adequate major organ functions
  • Hb ≥ 9.0 g/dL
  • White blood cell count ≥ 3000/μL
  • Absolute Neutrophil Count (ANC) ≥ 1500/μL [*ANC = neutrophil segs ＋ neutrophil bands]
  • Platelet ≥ 100 × 103/ μL
  • Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
  • Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine > 1.5 mg/dL , Ccr should be >= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
  • Life expectancy > 3month
  • Written informed consent

Exclusion criteria

  • Metastatic or recurrent stomach cancer other than adenocarcinoma
  • HER-2 positive
  • Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
  • Radiation therapy within the previous 2wks
  • Major surgery or trauma within the previous 4wks
  • Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
  • Uncontrolled brain metastasis
  • Presence of other serious disease (cardiovascular, hepatic, infection etc.)
  • Patients who participated in other clinical trials within the previous 30days
  • Men of childbearing potential not willing to use effective means of contraception

Treatment and study plan

Capecitabine/Cisplatin

Drug

Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks

S-1/Cisplatin

Drug

S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks

Capecitabine/Oxaliplatin

Drug

Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks

5-fluorouracil/oxaliplatin

Drug

5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks

Capecitabine

Drug

Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 1000mg/m2 po bid)

S-1

Drug

S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 30mg/m2 po bid)

5-fluorouracil

Drug

5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks

Primary outcomes

  1. comparison of overall survival

    Time frame: upto 3years

Secondary outcomes

  1. comparison of progression-free survival

    Time frame: upto 2years

  2. comparison of response rate

    Time frame: upto 2years

  3. comparison of adverse events

    Time frame: upto 2yrs

  4. comparison of quality of life

    Time frame: upto 2years

Other outcomes

  1. comprehensive geriatric assessment

    Time frame: baseline

    The investigators are going to evaluate that comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance to treatment, survival of patients.

    Comprehensive geriatric assessment will not necessarily be tested in all subjects, but instead, screening tool (KG-7 (Korean screening tool for the elderly)) will be tested in all subjects.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korean Cancer Study Group
  • Ministry of Health & Welfare, Korea

Registry information

Official study title

Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer; Multicenter Randomized Phase 3 Study

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2014
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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