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Esophageal NeoplasmsPhase 2NCT00160030

Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer

A Phase 2 study testing FOLFOX 4 and 5-FU / Cisplatin in people with Esophageal Neoplasms, run by Sanofi at 1 site in France.

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

The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms. The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Neoplasms
What is being tested?
FOLFOX 4 and 5-FU / Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteFrance
Study dates
Sep 2004to Oct 2007
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with:
  • Histologically proven adenocarcinoma, squamous cell or adenosquamous carcinoma of the esophagus
  • Inoperable esophageal carcinoma (disease status: any T, N0 or N1, M0 or M1a) or surgical contraindication conditions
  • No prior treatment for esophageal cancer (surgery, laser, chemo- or radiotherapy)
  • Oesophageal dilatation is allowed before or during the treatment, but prior esophageal prosthesis is not allowed
  • Peripheral neuropathy <= NCI-CTC grade 1
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  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
  • Sufficient (oral or with gastrostomy) calorific intake (> 1000 Kcal/m2/day)
  • Life expectancy >= 3 months
  • Adequate bone marrow reserve, normal renal and liver functions:
  • Neutrophil count >= 1500/mm³
  • Platelet count >= 100,000/mm³
  • Hemoglobin >= 10 g/dl (after transfusion, if necessary)
  • Creatinine levels <= 1.5 x the upper normal limit of institutional values (ULN)
  • Total bilirubin level < 1.5 x ULN
  • ALT/AST < 2.5 x ULN
  • Prothrombin time >= 60%
  • Laboratory values obtained the week preceding study entry
  • Signed informed consent (prior to all study procedures)
  • Start of treatment within 28 days of inclusion.

Who cannot join

  • Metastatic disease except for third upper or cervical esophagus tumor with regional nodes, or third lower esophagus tumor with celiac nodes (M1a)
  • Multiple carcinomas of the esophagus
  • Small cell or undifferentiated carcinoma of the esophagus
  • Complete dysphagia (grade 4 NCI-CTC); patient with exclusive parenteral nutrition.
  • Weight loss > 20% normal body weight
  • Pregnant or breast-feeding women
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  • Fertile patient not using adequate contraception
  • Peripheral sensitive neuropathy with functional impairment
  • Auditory disorders
  • History of prior malignancies (other than cured non melanoma skin cancer, cured cervical carcinoma in situ or stage I or II node negative head and neck cancer cured > 3 years ago)
  • Prior cervical, thoracic and abdominal radiotherapy with field overlapping the proposed oesophageal radiotherapy field
  • Tracheo-oesophageal fistula or invasion of the tracheo-bronchial tree
  • Previous myocardial infarction (inferior or equal to 6 months). Patients with a previous myocardial infarction superior to 6 months, could be included only if: no transient ischemia is shown by thallium myocardial scintigraphy and favourable advice for chemotherapy is obtained from a cardiologist.
  • Other serious illness or medical conditions (such as symptomatic coronary disease, left ventricular failure or uncontrolled infection)
  • Arterial disease stage II to IV according to the Leriche and Fontaine classification
  • Treatment with any other experimental drugs or participation in another clinical trial within 30 days of study screening
  • Concurrent treatment with any other anti-cancer therapy
  • Concurrent treatment with phenytoin and yellow fever vaccine; geographical, social or psychological circumstances preventing regular follow-up.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Sanofi-Aventis

    Paris

Other trials in France

About this study

Official title: Phase II Study Comparing Radiochemotherapy With the Folfox 4 Regimen Versus Radiochemotherapy With 5FU-Cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Esophageal Cancer

The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.

The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).

Being tested
FOLFOX 4, 5-FU / Cisplatin
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • FOLFOX 4Drug

    total treatment of six 2-weekly cycles of FOLFOX 4, the first 3 cycles starting on D1, D15 and D29 concomitant with 5 weeks' radiotherapy.

  • 5-FU / CisplatinDrug

    two cycles of 5-FU / Cisplatin on week 1 and 5 of radiotherapy and two cycles of chemotherapy with 5-FU / Cisplatin on week 8 and 11 (one cycle each three weeks after the end of radiotherapy).

Study groups in NCT00160030
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: FOLFOX 4
2Active comparatorNot described
Receives: Drug: 5-FU / Cisplatin

What is being measured

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

  1. Percentage of patients having completed the full treatment and Endoscopic complete response rate

    Measured: at the end of the study

Secondary outcomes (1)

  1. Toxicity profile (NCI-CTC).

    Measured: evaluated each week

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionOct 2007

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
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00160030
Sponsor's protocol ID
L_9326
Status last verified
Dec 2009
First submitted
9 Sep 2005
Last updated
7 Dec 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOX 4 and 5-FU / Cisplatin in people with Esophageal Neoplasms, run by Sanofi at 1 site 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 21 inclusion and 19 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 7 Dec 2009. 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 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?

Percentage of patients having completed the full treatment and Endoscopic complete response rate (time frame: at the end of the study). 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 NCT00160030.

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 7 Dec 2009.

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