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Esophageal CarcinomaPhase 2NCT00733889

A Study to Evaluate the Combination of Cetuximab and Chemotherapy as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy Plus Cetuximab in Locoregional Esophageal Carcinoma

A Phase 2 study testing cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) in people with Esophageal Carcinoma, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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 purpose of the study is to determine efficacy ans safety of the combination of cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional esophageal carcinoma Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Carcinoma
What is being tested?
cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
Dec 2006to Nov 2012
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent form signed before performing any of the study's specific procedures.
  • Age > 18 and < 70.
  • Karnofsky performance status > 70% upon inclusion in the study.
  • Life expectancy of more than 3 months.
  • Histologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the oesophagus or the gastroesophageal junction. The disease must be confined to the oesophagus or gastroesophageal junction and the perioesophageal region. There must be no tumor extension beyond 2 cm into the stomach.
  • Stages II or III. The patients must have a T1N1M0 or T2-4; any N; M0. The only exception would be patients with stage IVA: an oesophageal carcinoma of the upper thoracic region with metastasis in cervical lymph nodes (M1a) and an oesophageal carcinoma of the lower thoracic region with metastasis in the celiac lymph nodes (M1a), providing the disease remains within the radiotherapy fields.
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  • Presence of a unidimensionally measurable and/or assessable lesion
  • Neutrophils >1500/mm3, platelet count >150,000/mm3 and haemoglobin >10 g/dl.
  • Adequate renal function: serum creatinine < 120 micromol/l (1.4 mg/dl); if the values are >120 micromol/l (1.4 mg/dl) creatinine clearance must be > 65 ml/min.
  • Adequate liver function: total bilirubin <1 x NUL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x NUL; alkaline phosphatase (AP) < 5 x NUL. Patients with AST and/or ALT > 1.5 < 2.5 x NUL and AP > 1.5 x NUL < 5 x NUL are not eligible.
  • Serum calcium <1.25 x normal upper limit (NUL).
  • Adequate nutritional status: weight loss < 20% of regular weight and albumin > 35 g/l.
  • Total oral and/or enteral intake should be at least 1700 calories/day.
  • Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
  • Availability of tumour tissue for immunohistochemical analysis of EGFR expression and other biological markers.

Who cannot join

  • Patients with a tracheo-oesophageal fistula or direct invasion of the tracheal mucosa or a major bronchi are not eligible. Bronchoscopy (with biopsy and cytology if lesion is seen) is required in order to rule out a fistula and/or direct invasion if the primary tumour is < than 30 cm from the incisors. Bronchoscopy is also required when the primary tumour is shown to be at or above the carina by an imaging study.
  • Prior thoracic radiotherapy and/or systemic chemotherapy and/or oesophageal surgery.
  • Patients with multiple carcinoma of the oesophagus.
  • Diagnosis of any other cancer in the previous 5 years with the exception of appropriately treated carcinoma in situ of the uterine cervix and/or basal cell carcinoma of the skin.
  • Systemic, chronic and concomitant immune treatment, or anti-cancer hormone therapy.
  • Other concomitant cancer treatments.
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  • Active infection (infection requiring intravenous antibiotics), including active tuberculosis and diagnosed HIV.
  • Uncontrolled hypertension defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 130 mmHg at rest.
  • Active, uncontrolled, gastric or duodenal peptic ulcer.
  • Chronic obstructive pulmonary disease requiring hospitalisation in the 6 months prior to inclusion in the study.
  • History of atrioventricular arrhythmia and/or cardiac failure and/or second or third degree heart block.
  • Clinically significant coronary artery disease or history of myocardial infarction in the last 12 months .
  • Peripheral neuropathy grade > 2 NCIC-CTG of any aetiology.
  • Hearing disorder grade > 2 NCIC-CTG of any aetiology.
  • Any other disease or medical disorder suggesting that the patient will not be able to complete the study.
  • Any psychological disorder suggesting that the complete treatment will not be possible.
  • Pregnancy (its absence must be confirmed by the serum HCG-betatest) or lactation.
  • Known drug abuse (with the exception of the mild or moderate consumption of alcohol upon inclusion in the study).
  • Known allergic reaction to any of the components in the study treatment.
  • Prior treatment with monoclonal antibodies or other signal transduction inhibitors or EGFR-targeted treatment.
  • Evidence of another cancer, with the exception of a carcinoma in situ of the uterine cervix and/or a basal cell carcinoma of the skin.
  • Any experimental treatment in the 30 days prior to inclusion in the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

    Madrid, 28046

Other trials in Spain

About this study

Official title: Phase II, Multicentre, Uncontrolled Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Chemotherapy (Docetaxel, Cisplatin, 5-fluorouracil) as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy (Cisplatin) Plus Cetuximab in Patients With a Locoregional Esophageal Carcinoma

The purpose of the study is to determine efficacy ans safety of the combination of cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional esophageal carcinoma

Being tested
cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)
Keywords
esophageal carcinoma, cetuximab, docetaxel, cisplatin, 5-fluorouracil
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)Drug

    Neoadjuvant chemotherapy plus cetuximab:

    3 cycles of chemotherapy (Docetaxel: 75 mg/m2; day1; Cisplatin :75 mg/m2, day 1; 5-FU: 750 mg/m2; 24-hour infusion; day1-5) administered every 3 weeks, plus cetuximab (250 mg/m2; day 1, 8 and 15) Cetuximab will be maintained from the beginning of chemotherapy until the end of radiotherapy.

    Radio-chemotherapy plus cetuximab:

    The radiotherapy treatment: A dose of 50.4 Gy will be administered in 28 fractions of 1.8 Gy / day, 5 days a week (a total of 5.6 weeks).

    Cetuximab:250 mg/m2 and Cisplatin: 40 mg/m2, day 1, 8, 15, 22, 29 and 36

Study groups in NCT00733889
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)

What is being measured

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

  1. • Complete clinical response rate and objective clinical response rate after the administration of 3 cycles of chemotherapy plus cetuximab and after induction chemotherapy followed by concomitant chemoradiotherapy plus cetuximab

    Measured: 2006-2010

Secondary outcomes (4)

  1. • To determine the complete pathological response rate in the patients subject to radical surgery, according to the investigators' criteria and the policy of each centre.

    Measured: 2006-2010

  2. Adverse events

    Measured: 2006-2010

  3. • To study the locoregional control of the disease, the therapeutic failure patterns, specific disease-free survival, event-free survival, disease-specific survival and global survival

    Measured: 2006-2012

  4. • To determine EGFR expression in the tumour and attempt to correlate it with efficacy

    Measured: 2006-2010

Timeline

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

  1. First posted13 Aug 2008 (estimated)
  2. Study startDec 2006
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00733889
Sponsor's protocol ID
TTD-06-02
Other IDs
EudraCT number:2006-001880-42
Status last verified
Feb 2013
First submitted
12 Aug 2008
Last updated
20 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • Alsina M, Rivera F, Ramos FJ, Galan M, Lopez R, Garcia-Alfonso P, Ales-Martinez JE, Queralt B, Anton A, Carrato A, Gravalos C, Mendez-Vidal MJ, Lopez C, de Mena IR, Tabernero J, Giralt J, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD) and Grupo de Investigacion Clinica en Oncologia Radioterapica (GICOR). A phase II Study Evaluating Combined Neoadjuvant Cetuximab and Chemotherapy Followed by Chemoradiotherapy and Concomitant Cetuximab in Locoregional Oesophageal Cancer Patients. Target Oncol. 2018 Feb;13(1):69-78. doi: 10.1007/s11523-017-0536-z.

    PubMed 29128908

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) in people with Esophageal Carcinoma, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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 22 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 20 Feb 2013. 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 Spain. 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?

• Complete clinical response rate and objective clinical response rate after the administration of 3 cycles of chemotherapy plus cetuximab and after induction chemotherapy followed by concomitant chemoradiotherapy plus cetuximab (time frame: 2006-2010). 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 NCT00733889, which also lists 1 linked publication.

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 20 Feb 2013.

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