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Gastric CancerPhase 2TOXAGNCT01748773

A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer

A Phase 2 study testing Oxaliplatin, Radiation and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Hoffmann-La Roche at 9 sites in Turkey (Türkiye).

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

This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Oxaliplatin, Radiation and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
9 sitesTurkey (Türkiye)
Study dates
29 Jan 2013to 15 Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result
  • Participants with stages between Stage IB (T1N1M0) and Stage IIIC
  • ECOG performance status score equal to or less than (<=) 2 during screening
  • Left ventricular ejection fraction equal to or higher than (>=) 55% with acceptable levels of liver and renal functions
  • No known contraindication to capecitabine, oxaliplatin, and trastuzumab
  • No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason

Who cannot join

  • Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin
  • Previous neoadjuvant chemotherapy and/or radiotherapy
  • Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma)
  • Known (previously diagnosed and ongoing) malabsorption syndrome
  • Active gastrointestinal bleeding
  • Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma
Show all 12Show fewer
  • Clinically significant cardiac or cardiovascular disease
  • Uncontrolled hypertension
  • Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study
  • Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin
  • Known or suspected hypersensitivity against trastuzumab or proteins of rodents
  • Pregnancy or lactation

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Turkey (Türkiye)9 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

    Adana, 01250

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Ankara, 06100

  • Ankara Oncology Hospital; Oncology

    Ankara, 06200

  • Baskent University Medical Faculty; Internal Medicine

    Ankara, 06490

  • Bilkent Sehir Hospita; ONKOLOJI

    Çankaya/Ankara, 06800

  • Gaziantep University Medical Faculty, Medical Oncology Department

    Gaziantep, 27310

  • Marmara Uni Faculty of Medicine; Medical Oncology

    Istanbul, 34890

  • Ege Uni Medical Faculty; Oncology Dept

    Izmir, 35100

  • Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

    Konya, 42080

Other trials in Turkey (Türkiye)

About this study

Official title: Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Operated Patients With HER-2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma: Phase II Study, TOXAG [ML25574]

This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin 100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year plus a 1-year follow-up period.

Medical subject headings
Stomach Neoplasms

What participants receive

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

  • OxaliplatinDrug

    Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.

  • RadiationRadiation

    Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.

  • CapecitabineDrug

    Participants will receive capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.

  • TrastuzumabDrug

    Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).

Study groups in NCT01748773
Study groupRoleWhat they receive
Combination TherapyExperimentalParticipants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
Receives: Drug: Oxaliplatin; Radiation: Radiation; Drug: Capecitabine; Drug: Trastuzumab

What is being measured

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

  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Baseline up to Month 13

  2. Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score

    Measured: From Baseline to Month 13

Secondary outcomes (2)

  1. Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST)

    Measured: Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)

  2. Overall Survival

    Measured: Cycle 1 Day 1 up to death due to any reason (up to 24 months)

Timeline

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

  1. First posted13 Dec 2012 (estimated)
  2. Study start29 Jan 2013
  3. Primary completion21 Aug 2015
  4. Study completion15 Jun 2017

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01748773
Sponsor's protocol ID
ML25574
Acronym
TOXAG
Status last verified
Oct 2019
First submitted
10 Dec 2012
Last updated
9 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Abali H, Yalcin S, Onal HC, Dane F, Oksuzoglu B, Ozdemir N, Mertsoylu H, Artac M, Camci C, Karabulut B, Basal FB, Budakoglu B, Sendur MAN, Goktas B, Ozdener F, Baygul A. A Phase II Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab and Chemoradiotherapy in the Adjuvant Setting in Operated Patients With HER2-positive Gastric or Gastroesophageal Junction Cancer (TOXAG Study): A Turkish Oncology Group Study. Am J Clin Oncol. 2021 Jul 1;44(7):301-307. doi: 10.1097/COC.0000000000000825.

    PubMed 33979100

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Radiation and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Hoffmann-La Roche at 9 sites in Turkey (Türkiye).

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 6 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Month 13). The study lists 2 primary outcomes in all. 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 NCT01748773, 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 9 Oct 2019.

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