AzTrials
AzTrials

Adenocarcinoma of the Gastroesophageal JunctionPhase 2NCT01360086

Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction

A Phase 2 study testing cetuximab, cisplatin and fluorouracil in people with Adenocarcinoma of the Gastroesophageal Junction and Gastric Cancer, run by Federation Francophone de Cancerologie Digestive at 2 sites in France.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
cetuximab, cisplatin and fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesFrance
Study dates
Jun 2011to Mar 2013
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  • Stage IB, II, or III disease according to TNM classification OR type I, II, or III disease according to Siewert classification
  • TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)
  • Disease considered operable with curative intent
  • No gastric scirrhous carcinoma (linitis plastica)
  • Forms with independent cells are not considered linitis
  • Measurable disease according to RECIST V1.1
  • No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the gastroesophageal junction type I

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Polynuclear neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine clearance > 50 mL/min
  • Bilirubin < 1.5 times normal
  • Serum albumin > 30 g/L
  • Prothrombin time ≥ 80%
  • FEV1 > 1 L in case of thoracotomy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known cirrhosis
  • No other progressive condition that has not been stabilized including the following:
  • Hepatic failure
  • Renal failure
  • Respiratory failure
  • NYHA class III-IV congestive heart failure
  • Unstable angina
  • Myocardial infarction in the past 6 months
  • Significant arrhythmias in the past 12 months
  • No recent weight loss exceeding 15%
  • No interstitial pneumonia
  • No other malignant tumor within the past 5 years except for basal cell skin carcinoma or cancer in situ of the cervix
  • No psychological, familial, or geographical reasons that will preclude the patient being monitored regularly
  • No persons deprived of liberty or under guardianship (Disability Act)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy for gastric cancer
  • No other concurrent anticancer treatment, immunotherapy, or hormone therapy
  • No prior abdominal or thoracic radiotherapy

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • CHU - Robert Debre

    Reims, 51092

Other trials in France

About this study

Official title: Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin, and leucovorin calcium together with cetuximab and to see how well they work in treating patients with adenocarcinoma of the stomach or gastroesophageal junction.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the objective response rate according to RECIST V1.1 criteria in patients with adenocarcinoma of the stomach or gastroesophageal junction treated with neoadjuvant chemotherapy comprising fluorouracil, cisplatin, leucovorin calcium, and cetuximab followed by surgery and adjuvant chemotherapy.
  • To determine the non-toxicity rate in these patients.

Secondary

  • To determine the rate of macroscopically and microscopically complete surgical resection (R0).
  • To determine the overall tolerance in patients treated with this regimen.
  • To determine post-operative mortality and morbidity in these patients.
  • To determine the rate of recurrence at 1 and 2 years in these patients.
  • To determine recurrence-free survival at 3 years in these patients.
  • To determine disease-free survival at 3 years in these patients.
  • To determine overall survival at 3 years in these patients.
  • To determine quality of life using EORTC QLC-C30 and STO-22 questionnaires.
  • To determine the correlation between the response rate and the degree of skin toxicity.

OUTLINE: This is a multicenter study.

  • Neoadjuvant therapy and surgery: Patients receive leucovorin calcium IV over 2 hours, cisplatin IV, fluorouracil IV continuously over 46 hours, and cetuximab IV over 1-2 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks after completing neoadjuvant chemotherapy, patients undergo surgery.
  • Adjuvant therapy: Within 4-8 weeks after completing neoadjuvant chemotherapy, patients receive leucovorin calcium, cisplatin, fluorouracil, and cetuximab as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires (QLC-C30 and STO-22) periodically. Blood and tissue samples are collected periodically for correlative and translational studies.

After completing study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 1 year.

Keywords
adenocarcinoma of the gastroesophageal junction, adenocarcinoma of the stomach, stage IB gastric cancer, stage IIA gastric cancer, stage IIB gastric cancer, stage IIIA gastric cancer, stage IIIB gastric cancer, stage IIIC gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

Study groups in NCT01360086
Study groupRoleWhat they receive
Perioperative CT with 5FU-Cisplatine-CetuximabExperimental6 cycles of intravenous Cetuximab (500mg/m²), Cisplatine (50mg/m²) and LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks. Surgery was planned 3-4 weeks after the end of neaodjuvant CT and postoperative CT, with the same regimen, planned for 6-8 weeks after surgery.
Receives: Biological: cetuximab; Drug: cisplatin; Drug: fluorouracil; Drug: leucovorin calcium; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery

What is being measured

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

  1. Objective response rate according to RECIST V1.1 criteria

    Measured: 3 months

  2. Non-toxicity rate

    Measured: 3 months

Secondary outcomes (7)

  1. Tolerance

    Measured: From Inclusion

  2. Post-operative mortality and morbidity

    Measured: After Surgery

  3. Rate of recurrence at 1 and 2 years

    Measured: 1 year and 2 years

  4. Recurrence-free survival at 3 years

    Measured: 3 years

  5. Disease-free survival at 3 years

    Measured: 3 years

  6. Overall survival at 3 years

    Measured: 3 years

  7. Quality of life as assessed by QLC-C30 and STO-22 questionnaires

    Measured: From inclusion

Timeline

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

  1. First posted25 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01360086
Sponsor's protocol ID
CDR0000699219
Other IDs
FFCD-0901, EU-21111, EUDRACT-2010-023115-33, MERCK-FFCD-0901
Status last verified
May 2016
First submitted
20 May 2011
Last updated
30 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.

    PubMed 24982463

  • Gronnier C, Mariette C, Lepage C, Monterymard C, Jary M, Ferru A, Baconnier M, Adhoute X, Tavan D, Perrier H, Guerin-Meyer V, Lecaille C, Bonichon-Lamichhane N, Pillon D, Cojocarasu O, Egreteau J, D'journo XB, Dahan L, Locher C, Texereau P, Collet D, Michel P, Ben Abdelghani M, Guimbaud R, Muller M, Bouche O, Piessen G. Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study. Cancers (Basel). 2023 Apr 6;15(7):2188. doi: 10.3390/cancers15072188.

    PubMed 37046849

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, cisplatin and fluorouracil in people with Adenocarcinoma of the Gastroesophageal Junction and Gastric Cancer, run by Federation Francophone de Cancerologie Digestive at 2 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?

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 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

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?

Objective response rate according to RECIST V1.1 criteria (time frame: 3 months). 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 NCT01360086, which also lists 2 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 30 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in