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Esophageal CancerPhase 1/2NCT00008047

Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus

A Phase 1/2 study testing fluorouracil, hydroxyurea and paclitaxel in people with Esophageal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 14 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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Cancer
What is being tested?
fluorouracil, hydroxyurea and paclitaxel
Type of treatment
Surgery or procedure
How many people
Not given
Where
14 sitesFrance
Study dates
Aug 1999to not given
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage II (T2 or T3, N0, M0) or III (T3, N1, M0) epidermoid carcinoma of the esophagus
  • Inoperable due to initial extension or inoperable with no extension
  • No visceral metastases
  • No extension to the tracheo-bronchial pathway
  • No tracheo-esophageal fistula
  • No broncho-esophageal fistula
  • No suspected respiratory mucosal involvement on bronchoscopy
  • No carcinoma in situ

PATIENT CHARACTERISTICS:

Age:

  • 18 to 80

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least 120,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Neutrophil count at least 1,500/mm^3
  • Lymphocyte count at least 1,000/mm^3

Hepatic:

  • SGOT and SGPT no greater than 2 times normal
  • Albumin at least 3.0 g/dL

Renal:

  • Creatinine no greater than 1.4 mg/dL
  • Calcium less than 11.2 mg/dL

Pulmonary:

  • See Disease Characteristics
  • No severe respiratory illness (e.g., severe broncho-pathway obstruction or insufficient respiration)
  • No uncontrolled broncho-pulmonary infection

Other:

  • No other prior history of malignancy except curatively treated carcinoma in situ of the colon or skin cancer
  • No contraindication to fluorouracil
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No psychiatric illness
  • HIV negative
  • Total protein at least 65% of normal

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No prior endocrine therapy

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent participation in other study

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Hopital Saint-Louis

    Amiens, 80054 Cedex 1

  • Clinique Saint Vincent

    Besançon, 25044

  • Clinique Saint - Jean

    Cagne-sur-Mer, 06800

  • CHR de Grenoble - La Tronche

    Grenoble, F-38043

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • CMC Les Ormeaux

    Le Havre, 76600

  • Centre Jean Bernard

    Le Mans, 72000

  • Hopital Laennec

    Paris, 75007

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Tenon

    Paris, 75970

  • Clinique Ste - Marie

    Pontoise, 95301

  • Polyclinique De Courlancy

    Reims, F-51100

  • C.H. Senlis

    Senlis, 60309

  • Clinique Fleming

    Tours, 37000

Other trials in France

About this study

Official title: Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of concurrent radiotherapy with fluorouracil and hydroxyurea with or without paclitaxel in terms of survival without dysphagia in patients with inoperable stage II or III epidermoid carcinoma of the esophagus.
  • Compare the overall survival, response rate, toxicity, and quality of life in this patient population treated with these regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to weight loss (less than 10% vs at least 10%) and inoperability criteria (nonresectable vs due to anatomical terrain). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive fluorouracil IV continuously, oral hydroxyurea, and concurrent radiotherapy daily on days 1-5.
  • Arm II: Patients receive fluorouracil, hydroxyurea and radiotherapy as in arm I. Patients also receive paclitaxel IV on day 1.

Treatment continues every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients with possible resectable disease undergo surgical resection at 4-6 weeks following the last course of chemoradiotherapy. Patients with continued unresectable disease receive 2 additional courses of chemoradiotherapy as above within 8-17 days following the last course of chemoradiotherapy.

Quality of life is assessed at baseline, monthly during therapy, every 2 months for 6 months, every 4 months for 1 year, and then every 6 months thereafter.

Patients are followed every 2 months for 6 months, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 90 patients will be accrued for this study.

Being tested
fluorouracil, hydroxyurea, paclitaxel, conventional surgery, radiation therapy
Keywords
stage II esophageal cancer, stage III esophageal cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

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

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 1999

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00008047
Sponsor's protocol ID
CDR0000068368
Other IDs
FRE-GERCOR-D99-1, EU-20021
Status last verified
Feb 2001
First submitted
6 Jan 2001
Last updated
9 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing fluorouracil, hydroxyurea and paclitaxel in people with Esophageal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 14 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: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00008047.

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 Feb 2009.

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