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AzTrials

Stage T3-4NxM0 Gastric CancerPhase 2NCT00414271

Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer

A Phase 2 study testing Docetaxel and Capecitabine in people with Stage T3-4NxM0 Gastric Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thymidylate Synthase (TS) is a key enzyme in the synthesis of DNA and the target enzyme inhibited by 5-fluorouracil (5-FU). TS level in the tumour cells has been reported as predictive to response to 5-FU and a prognostic factor in colorectal and gastric cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage T3-4NxM0 Gastric Cancer
What is being tested?
Docetaxel and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSingapore
Study dates
Jan 2006to Oct 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater than or equal 18 years.
  • Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia (Siewert Classification Type III)
  • Preoperative Stage T3-4NxM0 by endoscopic ultrasound, CT of the abdomen/pelvis and laparoscopy. (CT of the chest if it is a cardia lesion).
  • Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination.
  • Patients must not have received any prior chemotherapy or hormonal therapy for the treatment of gastric cancer.
  • Karnofsky performance status of 70 or higher.
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  • Estimated life expectancy of at least 12 weeks.
  • Adequate organ function including the following:
  • Bone marrow:
  • White blood cells (WBC) greater than or equal 3.5 x 109/L
  • Absolute neutrophil (segmented and bands) count (ANC) greater than or equal 1.5 x 109/L
  • Platelets greater than or equal 100 x 109/L
  • Haemoglobin greater than or equal 9g/dL
  • Hepatic:
  • Bilirubin within upper limit of normal (ULN),
  • ALT or AST less than or equal 2.5x ULN
  • Alkaline phosphatase less than or equal 2.5x ULN.
  • Renal:
  • creatinine less than or equal 1.5x ULN
  • Signed informed consent by patient or legal representative.
  • Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Who cannot join

  • Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic disease will render patient ineligible according to American Joint Committee on Cancer (AJCC) staging manual. (See appendix 11.4).
  • Treatment within the last 30 days with any investigational drug.
  • Concurrent administration of any other cancer therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
  • Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
  • Pregnancy.
  • Breast-feeding.
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  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • Poorly controlled diabetes mellitus with fasting blood sugar > 18 mmol/L(mM).
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  • History of significant neurological or mental disorder, including seizures or dementia.
  • History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.
  • History of hypersensitivity to 5-fluorouracil

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Johns Hopkins Singapore International Medical Center

    Singapore, 308433

Other trials in Singapore

About this study

Official title: A Phase II Study of Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer

Thymidylate Synthase (TS) is a key enzyme in the synthesis of DNA and the target enzyme inhibited by 5-fluorouracil (5-FU). TS level in the tumour cells has been reported as predictive to response to 5-FU and a prognostic factor in colorectal and gastric cancer patients. We plan to study TS by immunohistochemistry (IHC) in the paraffin blocks of tumour tissue.

A combined comparative genomic hybridization (CGH) and expression microarray analysis of gastric cancer specimens before and after neoadjuvant chemotherapy. CGH will be performed using standard technique routinely done in Dr Patrick Tan's laboratory at the National Cancer Centre, which determines the gain or loss of DNA copies of each chromosome. Total RNA will be extracted from at least one biopsy sample which contains at least 50% cancer cells by homogenization of the tumour tissue and tri-sol method. 5 ug of RNA were amplified and hybridized with the C-DNA microarrays of 18K targets.

Read more

Primary Objective 1. Feasibility and safety of pre-operative chemotherapy in locally advanced gastric cancer.

Secondary Objective

  1. Complete clinical and pathological response rates to pre-operative chemotherapy in locally advanced gastric cancer
  2. Complete resection rate.
  3. Time to recurrence, disease free and overall survival
  4. Correlation of clinical outcome with (Runt-related transcription factor) RUNX-3 methylation status and Thymidylate synthetase in the tumor tissue.
  5. Correlation of CGH and gene expression profile and their changes after chemotherapy with clinical outcome. Patients may be included in the study only if they meet all of the following criteria: Age at least 18 years. Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia (Siewert Classification Type III) Preoperative Stage T3-4NxM0 by endoscopic ultrasound, CT of the abdomen/pelvis and laparoscopy. (CT of the chest if it is a cardia lesion). Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination. Patients must not have received any prior chemotherapy or hormonal therapy for the treatment of gastric cancer. Karnofsky performance status of 70 or higher. Estimated life expectancy of at least 12 weeks. Adequate organ function including the following:
  • Bone marrow: White blood cells (WBC) at least 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) at least 1.5 x 109/L Platelets at least 100 x 109/L Haemoglobin at least 9g/dL
  • Hepatic: Bilirubin within upper limit of normal (ULN), Aspartate transaminase (ALT) or Alanine transaminase (AST) not more than 2.5x ULN Alkaline phosphatase not more than 2.5x ULN.
  • Renal: creatinine not more than 1.5x ULN Signed informed consent by patient or legal representative. Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. The study plans to recruit 30 patients in 12-18 months.
Being tested
Docetaxel, Capecitabine
Keywords
gastric cancer, neo-adjuvant chemotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Docetaxel 60 mg/m2 IV on day 1

  • CapecitabineDrug

    Capecitabine 900 mg/m2 PO two times per day from day 1 to day 14 every 3 weeks for 2 cycles.

Study groups in NCT00414271
Study groupRoleWhat they receive
Docetaxel and Capecitabine in gastric cancerExperimentalIntravenous docetaxel 60 mg/m2 on day 1 and oral capecitabine 900 mg/m2 two times per day from day 1 to day 14 every 3 weeks for 2 cycles.
Receives: Drug: Docetaxel; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Pathological Response

    Number of participants who completed neoadjuvant chemotherapy and underwent repeat CT and endoscopic ultrasound (EUS) with pathological complete response (pCR), partial response in the primary tumor, stable disease or progressive disease as defined by EUS criteria.

    Measured: up to 5 years

Secondary outcomes (4)

  1. Overall Survival

    Median number of months participants alive at the time of observation. Calculated using Kaplan-Meier method.

    Measured: up to 8 years

  2. Progression-free Survival as Measured by Number of Participants Without Disease Progression.

    Measured: up to 5 years

  3. Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE.

    Number of participants who experience Grade 3/4 neutropenia, Grade 3 nausea or Grade 3 diarrhea.

    Measured: up to 5 years

  4. Correlation of CGH and Gene Expression Profile and Their Changes After Chemotherapy With the Same Clinical Outcomes

    Initially, we also planned to study the thymidylate synthetase expression, methylation of RUNX-3 gene[24] and comprehensive genomic hybridization[25] before and after chemotherapy to look for biomarkers of response and prognostic indication. But due to the lack of pCR and the small number of patients enrolled, we stopped the correlative studies.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00414271
Sponsor's protocol ID
JS 0420
Other IDs
NA_00044000
Status last verified
May 2019
First submitted
20 Dec 2006
Last updated
25 Jul 2019
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chang AY, Foo KF, Koo WH, Ong S, So J, Tan D, Lim KH. Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer. BMJ Open Gastroenterol. 2016 Aug 23;3(1):e000095. doi: 10.1136/bmjgast-2016-000095. eCollection 2016.

    PubMed 27648294

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Capecitabine in people with Stage T3-4NxM0 Gastric Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Pathological Response (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00414271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.

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