Skip to content
Triangle logo TriangleGet started
← Study library

NCT01470443 · CITED IN SOURCE DOCUMENTS

Study of GEMOX(Gemcitabine/Oxaliplatin) Versus XELOX(Xeloda/Oxaliplatin) in Advanced Biliary Tract Carcinoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2019-05-21

The objective of the trial is to compare Progression free survival between GEMOX (gemcitabine/oxaliplatin)vs XELOX(capecitabine/oxaliplatin)in metastatic or unresectable Biliary tract carcinoma patients.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion criteria 1. age ≥ 18 2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer.however, ampulla of vater cancer is excluded) 3. unresectable or metastatic 4. ECOG performance status of 0\~2 5. measurable or evaluable lesion per RECIST 1.1 criteria 6. Life expectancy≥12weeks 7. Adequate marrow, hepatic, renal and cardiac functions Serum aspartate transaminase and serum alanine transaminase≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count(ANC) ≥ 1,500/uL Platelets ≥ 100,0000/uL Hemoglobin ≥ 8.0 g/dL 8. chemotherapy naïve patient: prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is \> 6 months from the study entry date 9. provision of a signed written informed consent Exclusion criteria 1. severe co-morbid illness and/or active infections 2. ampulla of vater cancer is excluded 3. pregnant or lactating women 4. Active CNS metastases not controllable with radiotherapy or corticosteroids (however,CNS metastases(except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid) 5. known history of hypersensitivity to study drugs
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    * Gemcitabine 1,000 mg/㎡, day 1 and 8, every 3 weeks * Oxaliplatin 100 mg/㎡, day 1, every 3 weeks
    intervention Names
    1. Drug: Oxaliplatin
    label
    GEMOX
    type
    ACTIVE_COMPARATOR
  2. description
    Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks Oxaliplatin 130mg/㎡, day 1, every 3 weeks
    intervention Names
    1. Drug: Oxaliplatin
    label
    XELOX
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. XELOX
    description
    Oxaliplatin 130mg/㎡, day 1, every 3 weeks
    name
    Oxaliplatin
    type
    DRUG
  2. arm Group Labels
    1. GEMOX
    description
    Oxaliplatin 100 mg/㎡, day 1, every 3 weeks
    name
    Oxaliplatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
240
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    reference 6 months PFS 50% (GEMOX arm), noninferiority 6 months PFS 35% (XELOX arm), 1:1 randomization, accrual 24 months, 6 months follow-up after the last patient registry.
    measure
    Progression free survival of GEMOX vs XELOX
    time Frame
    6 months PFS
secondary Outcomes
  1. description
    physical examination, vital signs, body weight, ECOG performance status, clinical laboratory evaluations (biochemistry, hematology, and urinalysis), and any AE graded by using CTCAE v 4. Data on dose intensity will also be calculated.
    measure
    Safety profile
    time Frame
    6 months follow-up after the last patient registry.
Full study description
brief Summary
The objective of the trial is to compare Progression free survival between GEMOX (gemcitabine/oxaliplatin)vs XELOX(capecitabine/oxaliplatin)in metastatic or unresectable Biliary tract carcinoma patients.
detailed Description
In patients with advanced BTC(biliary tract cancer), either gemcitabine-based, 5-FU-based chemotherapy or clinical trial is recommended as first-line treatment. According to ABC-02 trial, as compared with gemcitabine alone, cisplatin plus gemcitabine was associated with a significant survival advantage without the addition of substantial toxicity. Cisplatin plus gemcitabine is an appropriate option for the treatment of patients with advanced biliary cancer. (ClinicalTrials.gov number, NCT00262769.) Recent metaanalysis \[7\], analyzed 104 phase II and III trials comprising 2810 BTC patients and found that gemcitabine combined with platinum compounds such as cisplatin or oxaliplatin had superior response rate and survival when compared with gemcitabine alone. The metaanalysis concluded the combination of gemcitabine and cisplatin or oxaliplatin to be the reference arm for future clinical trials. Meanwhile, oxaliplatin (l-OHP), an alkylating diaminocyclohexane platinum derivate, has been noted to display a marked cytotoxic synergism in combination with fluoropyrimidines against a variety of solid human tumour cells \[11\]. Based on these information, Nehls et al. \[12\] conducted a prospective phase II study of oxaliplatin plus 5-FU/folinic acid in biliary system adenocarcinomas, and the disease control rate (responses and stable disease (SD)) was 56%, and the median OS was 9.5 months. To improve efficacy and to offer a more convenient treatment option for patients by reducing clinical visits and avoiding indwelling devices, they prospectively investigated the activity and toxicity profile of three-weekly intravenous oxaliplatin plus oral capecitabine (XELOX), and concluded that the XELOX regimen was a well-tolerated and active treatment option for advanced BTC \[13\]. Given a lack of prospective, direct, comparison between XELOX and GEMOX regimens in advanced BTC, we propose a randomized phase III trial of GEMOX (gemcitabine/oxaliplatin) vs XELOX (capecitabine/oxaliplatin) in metastatic or unresectable BTC patients. With the assumption of a median 6-month PFS rate of 50% in the GEMOX arm and 35% in the XELOX arm (non-inferiority margin, 15%), a total of 103 patients were required under a two-sided 5% significance level and 80% power, with an accrual of 59 months and a follow-up of 6 months after the last patient registry, to show the non-inferiority of XELOX to GEMOX. An exponential distribution of time to progression was assumed. Allowing a dropout rate of 10%, we aimed to enroll 230 patients. An interim analysis was not planned.
Source references
references
  1. citation
    Chen R, Zhang Y, Lin K, Huang D, You M, Lai Y, Wang J, Hu Y, Li N. Cost-Effectiveness Analysis of Capecitabine Plus Oxaliplatin Versus Gemcitabine Plus Oxaliplatin as First-Line Therapy for Advanced Biliary Tract Cancers. Front Pharmacol. 2022 Jul 22;13:871262. doi: 10.3389/fphar.2022.871262. eCollection 2022.
    pmid
    35935821
    type
    DERIVED
  2. citation
    Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. doi: 10.1093/annonc/mdz058.
    pmid
    30785198
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-9a5743cc8649806cf49c
      requested nct id
      NCT01470443
      primary nct id
      NCT01470443
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      d4a7e217ec32243df9c5b7a0755da84d57be19ef1fa455323f329ec970c1107a
      payload sha256
      08924daa706c3864018d6819431c30ee72b9020f78ac00a37ecc729910702db2
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-9a5743cc8649806cf49c
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT01470443
      occurrences
      1. context exact
        0.6&#8211;20.3) in arm A and 13.6 months (95% CI, 6.5&#8211;17.7) in arm B. </li></ul></div></li><li>A phase III noninferiority study (<a href="/clinicaltrials/NCT01470443">NCT01470443</a>) enrolled 114 patients with metastatic biliary tract cancers, including 30 (26%) with primary gallbladder cancer. Patients were randomly assig
        end
        123516
        exact text
        NCT01470443
        start
        123505
      2. context exact
        3) in arm A and 13.6 months (95% CI, 6.5&#8211;17.7) in arm B. </li></ul></div></li><li>A phase III noninferiority study (<a href="/clinicaltrials/NCT01470443">NCT01470443</a>) enrolled 114 patients with metastatic biliary tract cancers, including 30 (26%) with primary gallbladder cancer. Patients were randomly assigned to receiv
        end
        123529
        exact text
        NCT01470443
        start
        123518
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/3d798b07edbaae547e.html
      source file sha256
      d4a7e217ec32243df9c5b7a0755da84d57be19ef1fa455323f329ec970c1107a
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:58.285732+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      c63b4997a3ccf400d12acf814f2e7ce78a19db302ffdda1ce91a749ad6f733bd
      source title
      Bile Duct Cancer (Cholangiocarcinoma) Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 28, 2025
        datetime
        2025-03-28T12:00:00Z
        display
        March 28, 2025
    2. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-fdc6dec38fb499a027c2
      requested nct id
      NCT01470443
      primary nct id
      NCT01470443
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      17d650834f2c48a435a163b8f01e294d57ba5e21b76b4c1fae79dba5fe49f8e5
      payload sha256
      5732eb32954fa92a166f7d177e089a2e6f9eeb369a84e79aa4c66d12dbd0258c
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-fdc6dec38fb499a027c2
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT01470443
      occurrences
      1. context exact
        ansaminitis, which was more prevalent in the mGEMOX arm (<em>P</em> = .04). </li></ul></div></li><li>A phase III noninferiority study (<a href="/clinicaltrials/NCT01470443">NCT01470443</a>) enrolled 114 patients with metastatic biliary tract cancers, including 30 (26%) with primary gallbladder cancer. Patients were randomly assig
        end
        62796
        exact text
        NCT01470443
        start
        62785
      2. context exact
        which was more prevalent in the mGEMOX arm (<em>P</em> = .04). </li></ul></div></li><li>A phase III noninferiority study (<a href="/clinicaltrials/NCT01470443">NCT01470443</a>) enrolled 114 patients with metastatic biliary tract cancers, including 30 (26%) with primary gallbladder cancer. Patients were randomly assigned to receiv
        end
        62809
        exact text
        NCT01470443
        start
        62798
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/86c0af42176678a171.html
      source file sha256
      17d650834f2c48a435a163b8f01e294d57ba5e21b76b4c1fae79dba5fe49f8e5
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:42.824565+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      5dcee18031e5c8e1aeb2d95271a7763ae1f7c969517aeaac70ac5eaa39b87a26
      source title
      Gallbladder Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice