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Stomach CancerPhase 2SOCRATENCT03760822

Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

A Phase 2 study testing Ramucirumab and Paclitaxel in people with Stomach Cancer and Stomach Neoplasm, run by Federation Francophone de Cancerologie Digestive at 38 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Stomach Cancer, Stomach Neoplasm, Gastric Cancer
What is being tested?
Ramucirumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
38 sitesFrance
Study dates
16 Nov 2018to Dec 2024
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whatever HER2 status
  • Aged ≥ 70 years
  • WHO < 2
  • Estimated life expectancy > 3 months
  • Measurable or non-measurable disease according to RECIST 1.1 criteria
  • Documented progression during first-line fluoropyrimidine- and platinum- or irinotecan containing chemotherapy (with or without anthracycline), or during the 4 months following the last cycle of such chemotherapy administered for metastatic or locally advanced disease, or during the 6 months following the last dose of adjuvant therapy containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed)
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  • Adequate hepatic, renal and hematologic function:
  • ANC ≥ 1 500 / mm3, platelets ≥ 100 000 / mm3, hemoglobin ≥ 9 g/dL
  • Blood creatinine ≤ 1.5 x ULN and creatinine clearance (MDRD formula) ≥ 40 mL/min
  • Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN (≤ 5 x ULN if hepatic metastasis)
  • INR ≤ 1.5 or INR ≤ 3 for patients taking AVK and PTT ≤ 5 seconds above the ULN
  • Dipstick proteinuria ≤ 1+ or 24 hour proteinuria < 1 g in total
  • EORTC QLQ-C30 + QLQ-ELD14, completed and faxed to the Randomization, Management and Analysis Center of the FFCD
  • IADL geriatric questionnaire, completed and faxed to Randomization Management and Analysis Center of FFCD
  • Signed informed consent

Who cannot join

  • Known cerebral metastasis
  • Prior treatment by taxanes
  • Prior treatment with an antiangiogenic
  • Neuropathy of grade ≥ 2 (NCI-CTCAE 4.0)
  • Unresolved partial or total bowel obstruction, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or extensive gastrointestinal (GI) resection combined with chronic diarrhea
  • GI perforation and/or fistulae in the 6 months preceding randomization.
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  • GI bleeding within the last 3 months of grade ≥ 3 (NCI-CTCAE 4.0)
  • Chronic use of antiplatelet drugs (including aspirin, but a daily intake of ≤ 325 mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen), dipyridamole, clopidogrel or similar agents
  • Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) in the 6 months preceding randomization
  • A life-threatening episode of pulmonary embolism in the 6 months preceding randomization
  • Deep-vein thrombosis, pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant" during the 3 months prior to first dose of protocol therapy
  • Uncompensated congestive heart failure or uncontrolled arrhythmia
  • Uncontrolled hypertension (≥ 140/90 mm Hg for > 4 weeks) despite properly observed antihypertensive therapy
  • Cirrhosis at a level of Chilg-Pugh B or C; or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
  • Serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization
  • Radiotherapy or major surgery within 28 days of prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior the first dose of protocol therapy
  • Known allergy to paclitaxel or ramucirumab
  • Another concomitant cancer or a history of cancer in the last 5 years, except cervical carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other carcinoma in situ deemed to be successfully treated
  • Lack of effective contraception in patients (man and/or women) of childbearing age, and/or their
  • Persons deprived of liberty or under supervision
  • Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

France38 sites

  • CH -

    Abbeville

  • CH - Albi

    Albi

  • PRIVEE - L'Europe

    Amiens

  • CAC - ICO Site Paul Papin

    Angers

  • Privee - Hopital Prive

    Antony

  • Ch - Victor Dupouy

    Argenteuil

  • Ch - Metz Thionville Mercy

    Ars-Laquenexy

  • Ch - Ght Unyon Auxerre

    Auxerre

  • Privee - Institut Du Cancer Avignon Provence

    Avignon

  • Ch - Cote Basque

    Bayonne

  • Ch - Beauvais Ch

    Beauvais

  • Chu - Jean Minjoz

    Besançon

  • Privee - Tivoli

    Bordeaux

  • PRIVEE - Polyclinique Saint Privat

    Boujan-sur-Libron

  • Ch - Duchenne

    Boulogne-sur-Mer

  • Ch - Pierre Oudot

    Bourgoin

  • Privee - Pasteur Lanroze

    Brest

  • Cac - François Baclesse

    Caen

  • Chu - Côte de Nacre

    Caen

  • Ch - Jean Rougier

    Cahors

  • Privee - Infirmerie Protestante

    Caluire-et-Cuire

  • CH -

    Carcassonne

  • Ch - Castres Mazamet Chi

    Castres

  • Prive - Médipole de Savoie

    Challes-les-Eaux

  • Prive - Sainte Marie

    Chalon-sur-Saône

  • CH -

    Cholet

  • Ch - Hopitaux Civils de Colmar

    Colmar

  • Hopitaux civils de Colmar

    Colmar

  • Chu - Louis Mourier

    Colombes

  • Prive - Saint Côme

    Compiègne

  • Prive - Cédres

    Cornebarrieu

  • Chu - Henri Mondor

    Créteil

  • Prive - Centre Leonard de Vinci

    Dechy

  • Cac - Gf Leclerc

    Dijon

  • Chu - Francois Mitterrand

    Dijon

  • CH -

    Dunkirk

  • CHI - Elbeuf Louviers Val de Reuil

    Elbeuf

  • Clinique privée - CENTRE CARIO

    Plérin

Other trials in France

About this study

The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed.

The co-primary endpoints are the following:

  • Six months survival rate
  • Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future
Being tested
Ramucirumab, Paclitaxel
Keywords
ramucirumab, elderly patient, second line therapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • RamucirumabDrug

    Also called Cyramza

    IV ramucirumab at 8 mg/kg on D1 and D15

  • PaclitaxelDrug

    Also called Abraxane

    IV paclitaxel at 80 mg/m² on D1, D8 and D15

Study groups in NCT03760822
Study groupRoleWhat they receive
RamucirumabExperimentalIV ramucirumab at 8 mg/kg on D1 and D15
Receives: Drug: Ramucirumab
Ramucirumab + PaclitaxelActive comparatorIV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15
Receives: Drug: Ramucirumab; Drug: Paclitaxel

What is being measured

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

  1. Patient survival rate at 6 months

    Rate of patients alive

    Measured: at 6 months

  2. Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility

    Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.

    Measured: at 4 months

  3. Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future

    Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.

    Measured: at 4 months

  4. Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden

    Derived from items 43 and 44of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score

    Measured: at 4 months

Secondary outcomes (3)

  1. Overall survival

    Defined as time to death (whatever cause is) or for patients alive time to last news.

    Measured: 6 months

  2. Time to treatment failure

    Time between randomization and disease progression, treatment interruption or death

    Measured: 6 months

  3. Progression-free survival

    Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1

    Measured: 6 months

Timeline

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

  1. First posted30 Nov 2018
  2. Study start16 Nov 2018
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03760822
Sponsor's protocol ID
PRODIGE 55 - SOCRATE
Acronym
SOCRATE
Status last verified
Jul 2024
First submitted
17 Jul 2018
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramucirumab and Paclitaxel in people with Stomach Cancer and Stomach Neoplasm, run by Federation Francophone de Cancerologie Digestive at 38 sites in France.

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 15 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in France. 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?

Results are not available in the source record.

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?

Patient survival rate at 6 months (time frame: at 6 months). The study lists 4 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 NCT03760822.

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 8 Jul 2024.

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