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Gastric CancerPhase 3GASTRANOXNCT00718354

Overall Survival of Inoperable Gastric/GastroOesophageal Cancer Subjects on Treating With LMWH + Chemotherapy(CT) vs Standard CT

A Phase 3 study testing Enoxaparin and Standard Chemotherapy in people with Gastric Cancer and Gastroesophageal Cancer, run by Thrombosis Research Institute at 15 sites in India.

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

Due to evidence available both in terms of efficacy and safety of low molecular weight heparin, its use for the prevention of thromboembolic disease in cancer patients undergoing surgical intervention, and its extended use in higher doses for the prevention of recurrent thromboembolism in cancer patients with… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer, Gastroesophageal Cancer
What is being tested?
Enoxaparin and Standard Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
740 participants
Where
15 sitesIndia
Study dates
Jul 2008to Aug 2010
Phase
Phase 3
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

  • Signed written informed consent
  • Male or Female of age 18-75 years
  • Histologically confirmed gastric or gastro-oesophageal carcinoma.
  • Adenocarcinoma of the stomach stage III or IV considered inoperable at presentation.
  • ECOG performance status ≤ 1
  • Criteria for chemotherapy fulfilled (haematological, hepatic, renal).
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  • Ability to receive daily injection (self-injection or by patient relative).
  • Urine-Pregnancy test negative.
  • Consent to the use of Contraceptive for women of child bearing age group

Who cannot join

  • History of previous malignancy within the previous 5 years (except curatively treated carcinoma in situ of the uterine cervix, or basal cell carcinoma of the skin), or concomitant malignancy.
  • Prior treatment with chemotherapy or radiotherapy if relapse less than 6 months
  • Non-epithelial gastric tumours, borderline tumours.
  • Medically unstable patients, including but not limited to those with active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcaemia, uncompensated congestive heart failure, uncontrolled diabetes, persistent renal failure, dementia, seizures, superior vena cava syndrome.
  • Persistent renal failure (persistent value of the calculated creatinine clearance < 30 mL/min defined as a documented value < 30 mL/min on at least 2 occasions ≥ 3 days prior entry into the study).
  • Prosthetic heart valves.
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  • Any evidence of active bleeding disorder or risk of bleeding identified on fibroscopy done as a routine investigation before the consent for the trial. Fibroscopy is not mandatory to be done for the trial
  • Current, objectively-verified DVT, PE or other clinically significant thrombosis.
  • Documented previous episode of heparin-induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS).
  • Contraindications to anticoagulation
  • Coagulopathies (acquired or inherited)
  • Prior history of cerebral hemorrhage or neurosurgery within the previous month
  • Bacterial endocarditis
  • Uncontrolled arterial hypertension (systolic BP:200 mmHg or diastolic BP:110 mmHg) at 2 successive readings
  • Haemostatic abnormalities: circulating anticoagulant, baseline platelet count <50 000/mm3, activated partial thromboplastin time (aPTT) value 1.5 x the upper limit of normal, or International Normalized Ratio (INR) >1.5. The laboratory test valid would be no earlier than 14 days for this criterion.
  • Indication for thrombolytic therapy
  • Any long-term anticoagulant therapy for medical condition.
  • Immunocompromised subjects, such as subjects with known HIV and those who have either had an AIDS-defining condition (e.g. Kaposi's sarcoma, Pneumocystitis carinii pneumonia) or have CD4 + T-lymphocyte count < 200 /mm3.
  • Known hypersensitivity to heparin, or LMWH, or pork derived products.
  • Body weight >100 kg.
  • Pregnant or lactating women.
  • Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling to be tested for pregnancy (pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product
  • Participation in another clinical trial (study medications / study devices) within the previous 30 days. (Surgical trials are allowed).
  • Psychiatric disorders of altered mentation that would preclude understanding of the informed consent process.
  • Psychological, familial, sociological, or geographical conditions, which do not permit treatment and/or medical follow-up required to comply with the study protocol.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

India15 sites

  • Gujarat Cancer Research Institute, Civil Hospital Campus,Asarwa, ,

    Ahmedabad, Gujarat, 380016

  • Gokula Curie Cancer Centre,M.S.Ramaiah Memorial Hospital,MSR Nagar, MSRIT Post

    Bangalore, Karnataka, 560054

  • Department Of Radiotherapy,S.S.G. Hospital, -

    Baroda,Vadodara, Gujarat, 390 001

  • Acharya Tulsi Regional Cancer Treatment & Research Institute

    Bikaner, Uttar Pradesh

  • Cancer Hospital & Research Institute, Cancer Hill

    Gwalior, Madhya Pradesh, 474009

  • MGM Medical College & MY Hospital,

    Indore, M.P, 452005

  • B.P.Poddar Hospital & Medical Research Ltd,71/1, Humayun Kabir Sarani,, Block-G, New Alipore

    Kolkata, West Bangol, 700053

  • Chittaranjan National Cancer Institute,37, S.P.Mukhurjee Road

    Kolkata, West Bengal, 700026

  • Biswajit Sanyal

    Kolkata, West Bengal

  • Curie Manavta Cancer Centre, Opp.Hotel Sandeep Naka,Nashik

    Mumbai, Maharashtra, 425004

  • Dr. BRA IRCH,all India Institute of Medical Sciences,Ansari Nagar,

    New Delhi, 110029.

  • Mahavir Cancer Sansthan,Phulwari Sharif

    Patna, Bihar, 801505

  • Ruby Hall Clinic,Cancer Building,40 sassoon Road, , ,

    Pune, Maharashtra, 411001

  • Madhavan J.P.

    Trivandrum, Kerala, 695011

  • Mahatma Gandhi Cancer Hospital & Research Institute ,1/7 M.V.P. Colony, - ,, .

    Vishakhapattanam, Andhra Pradesh, 530017

Other trials in India

About this study

Official title: Randomized, Phase III-b, Multi-centre, Open-label, Parallel Study of Enoxaparin (Low Molecular Weight Heparin) Given Concomitantly With Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Gastric and Gastro-oesophageal Cancer

Due to evidence available both in terms of efficacy and safety of low molecular weight heparin, its use for the prevention of thromboembolic disease in cancer patients undergoing surgical intervention, and its extended use in higher doses for the prevention of recurrent thromboembolism in cancer patients with established thrombosis, with a view that the potential benefits for survival in cancer patients from low molecular weight heparin therapy comes because of a biological activity, the dose of 1mg/Kg (50% of the full treatment dose) for a period of 6 months coincident with 6 cycles of chemotherapy, has been chosen for this study.

Read the detailed description

In the GASTRANOX study, patients will have inoperable (locally advanced) or metastatic newly diagnosed gastric or gastro oesophageal cancer. These patients carry a definite thrombosis risk. Patients will be scheduled to have at least 6 months of palliative chemotherapy. During this period symptomatic thromboembolism will be common but currently no routine prophylaxis is provided.

The dose of Enoxaparin to be evaluated in this study is 1mg/kg. This represents half of the full treatment dose. For an average weight individual this will represent between 60 and 70 mg a day of Enoxaparin. The prophylactic dose for high-risk surgical patients in the United States is 60mg total daily dosing of Enoxaparin per day. This high-risk dose has been shown to be safe and effective in preventing thromboembolic disease in high-risk populations such as those undergoing major elective orthopaedic surgery. An alternative for high-risk dose is 40mg given once a day. This dose is also effective and safe. Thus the dose to be provided in the GASTRANOX study is not markedly different from the high-risk doses already in routine clinical practice either in North America (30mg twice a day - 60mg total daily dosing) or 40mg once a day in Europe. It is also half of the full treatment dose which has been shown to be effective and safe in the treatment of venous thromboembolism.

Since cancer patients are recognised to have bleeding risk it was felt inappropriate to provide the full treatment dose of Enoxaparin. Thus half the full treatment doses provided. On the other hand the biological effect of low molecular weight heparins in cancer suggests that higher doses be given to enhance the potential survival benefit.

The study is intended to evaluate the safety and efficacy of the study drug compared to best normal practice. The standard methodology for such a comparison is to conduct a randomized, comparative study.

Multi-centre: It is anticipated that a single centre will be unable to recruit sufficient subjects, in 1 year, to conduct the assessment and therefore multiple centres will be recruited to conduct the study.

Open Label: All patients will receive standard care at their site. It would not be feasible to expect placebo parenteral administration for six months. All VTE events will be adjudicated. Mortality is an objective end-point.

Standard treatment control: subjects will be treated according to best practice with half also receiving the study treatment.

Parallel-group: due to the nature of the condition this is the only practical design.

Being tested
Enoxaparin, Standard Chemotherapy
Keywords
Bleeding events
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • EnoxaparinDrug

    Once daily dose of 1mg/Kg of body weight for 6 months

  • Standard ChemotherapyDrug

    Also called Some commonly prescribed Chemotherapy regimens in India are:, - Epirubicin + Cisplatin + Capecitabine, - Capecitabine + Oxaliplatin, - Docetaxil + Carboplatin

    Investigator's discretion

Study groups in NCT00718354
Study groupRoleWhat they receive
BActive comparatorStandard Chemotherapy (upto 6 cycles)
Receives: Drug: Standard Chemotherapy
AExperimentalEnoxaparin: 1 mg/kg once daily in addition to standard chemotherapy up to 6 months
Receives: Drug: Enoxaparin

What is being measured

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

  1. Event Free Survival (EFS) - Composite endpoint of overall survival plus free of symptomatic VTE .

    Measured: up to 1 year from start of treatment

Secondary outcomes (1)

  1. Incidence of SVTE Overall survival Major and minor haemorrhages during chemotherapy and / or up to 30 days after last dose is provided. Serious adverse events, All reported adverse events HIT

    Measured: upto 1 year from the start of treatment

Timeline

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

  1. First posted18 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2010
  4. Study completionAug 2010

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
740 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00718354
Sponsor's protocol ID
TRI0702
Acronym
GASTRANOX
Status last verified
May 2015
First submitted
16 Jul 2008
Last updated
13 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. doi: 10.1016/s0959-8049(01)00267-2. No abstract available.

    PubMed 11602373

  • Lee YJ, Jy W, Horstman LL, Janania J, Reyes Y, Kelley RE, Ahn YS. Elevated platelet microparticles in transient ischemic attacks, lacunar infarcts, and multiinfarct dementias. Thromb Res. 1993 Nov 15;72(4):295-304. doi: 10.1016/0049-3848(93)90138-e.

    PubMed 8303669

  • Powell J, McConkey CC. The rising trend in oesophageal adenocarcinoma and gastric cardia. Eur J Cancer Prev. 1992 Apr;1(3):265-9. doi: 10.1097/00008469-199204000-00008.

    PubMed 1467772

  • Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.

    PubMed 10735013

  • Cohen AT, Wagner MB, Mohamed MS. Risk factors for bleeding in major abdominal surgery using heparin thromboprophylaxis. Am J Surg. 1997 Jul;174(1):1-5. doi: 10.1016/S0002-9610(97)00050-0.

    PubMed 9240942

  • Ajani JA. Chemotherapy for gastric carcinoma: new and old options. Oncology (Williston Park). 1998 Oct;12(10 Suppl 7):44-7.

    PubMed 9830625

  • Panzini I, Gianni L, Fattori PP, Tassinari D, Imola M, Fabbri P, Arcangeli V, Drudi G, Canuti D, Fochessati F, Ravaioli A. Adjuvant chemotherapy in gastric cancer: a meta-analysis of randomized trials and a comparison with previous meta-analyses. Tumori. 2002 Jan-Feb;88(1):21-7.

    PubMed 12004845

  • Petralia GA, Lemoine NR, Kakkar AK. Mechanisms of disease: the impact of antithrombotic therapy in cancer patients. Nat Clin Pract Oncol. 2005 Jul;2(7):356-63. doi: 10.1038/ncponc0225.

    PubMed 16075795

  • Thodiyil PA, Kakkar AK. Variation in relative risk of venous thromboembolism in different cancers. Thromb Haemost. 2002 Jun;87(6):1076-7. No abstract available.

    PubMed 12083490

  • Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.

    PubMed 11442521

  • Bergqvist D, Agnelli G, Cohen AT, Eldor A, Nilsson PE, Le Moigne-Amrani A, Dietrich-Neto F; ENOXACAN II Investigators. Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer. N Engl J Med. 2002 Mar 28;346(13):975-80. doi: 10.1056/NEJMoa012385.

    PubMed 11919306

  • Rasmussen MS. Does prolonged thromboprophylaxis improve outcome in patients undergoing surgery? Cancer Treat Rev. 2003 Jun;29 Suppl 2:15-7. doi: 10.1016/s0305-7372(03)80004-x.

    PubMed 12887945

  • Kakkar AK, Levine MN, Kadziola Z, Lemoine NR, Low V, Patel HK, Rustin G, Thomas M, Quigley M, Williamson RC. Low molecular weight heparin, therapy with dalteparin, and survival in advanced cancer: the fragmin advanced malignancy outcome study (FAMOUS). J Clin Oncol. 2004 May 15;22(10):1944-8. doi: 10.1200/JCO.2004.10.002.

    PubMed 15143088

  • Altinbas M, Coskun HS, Er O, Ozkan M, Eser B, Unal A, Cetin M, Soyuer S. A randomized clinical trial of combination chemotherapy with and without low-molecular-weight heparin in small cell lung cancer. J Thromb Haemost. 2004 Aug;2(8):1266-71. doi: 10.1111/j.1538-7836.2004.00871.x.

    PubMed 15304029

  • Lee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. doi: 10.1056/NEJMoa025313.

    PubMed 12853587

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin and Standard Chemotherapy in people with Gastric Cancer and Gastroesophageal Cancer, run by Thrombosis Research Institute at 15 sites in India.

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 9 inclusion and 25 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Event Free Survival (EFS) - Composite endpoint of overall survival plus free of symptomatic VTE . (time frame: up to 1 year from start of treatment). 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 NCT00718354, which also lists 18 linked publications.

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 13 May 2015.

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