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Esophageal CancerPhase 2/3NCT00160875

Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy, Plus Surgery for Resectable Esophageal Cancer

A Phase 2/3 study testing Irinotecan hydrochloride trihydrate and Cisplatin in people with Esophageal Cancer, run by University Health Network, Toronto at 1 site in Canada.

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

Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach, with one quarter to one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
Irinotecan hydrochloride trihydrate and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteCanada
Study dates
Apr 2009to Mar 2011
Phase
Phase 2/3
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

  • Histologically proven squamous or adenocarcinoma or the esophagus >20 cm from the incisors, including GE junction tumors (unless of gastric origin). GE junction tumors are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia
  • Clinical T1 N1 M0, T2-3 N0-1 M0, T1-3 N0-1 M1a
  • Performance status ECOG 0-2
  • Medically fit for chemotherapy, radiation and esophagectomy
  • Adequate bone marrow, hepatic and renal function as evidenced by the following:
  • Hematology:
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  • Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L
  • Hepatic function:
  • Total bilirubin < 1.25x ULN AST (SGOT) and ALT (SGPT) < 2.5 x ULN Alkaline phosphatase <2.5 x ULN
  • Renal function:
  • Serum creatinine < 160 umol/L or creatinine clearance > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows):
  • weight (kg) x (140 - age) K x serum creatinine
  • for serum creatinine in *mol/L, K=0.814 in man, K=0.96 in woman
  • No prior history of malignancy unless > 5 years disease free, or adequately treated nonmelanotic skin cancer or in situ carcinoma of the cervix
  • Tumor technically resectable (as defined in Section 5.4.3)

Who cannot join

  • In situ or clinical T1N0M0
  • Cervical esophageal tumors (within 20 cm of the incisors)
  • Positive cytology of the pleura, peritoneum or pericardium
  • Supraclavicular lymph node involvement
  • Invasion of tracheobronchial tree proven by bronchoscopy including but not limited to tracheo-esophageal fistula
  • Prior treatment for this malignancy except esophageal stenting
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  • Gilbert's disease
  • Age < 18
  • Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
  • Known hypersensitivity to either of study drugs or to any of their excipients.
  • Pregnant or lactating women. Men and women of reproductive potential (and women < 12 months after menopause) may not participate unless they have agreed to use an effective contraceptive method while on study
  • Known or suspected alcohol or drug abuse
  • Other serious or concurrent illnesses that may interfere with subject compliance, adequate informed consent, determination of causality of adverse events and which in the judgement of the Investigator, would make the patient inappropriate for entry into the study
  • Life expectancy < 3 months
  • Peripheral neuropathy > Grade 2 (using CTC Version 2)
  • Patients receiving phenytoin or phenobarbital

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II Study to Assess the Efficacy of Combined Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy (External Beam, Brachytherapy), Plus Surgery for Potentially Resectable Thoracic Esophageal Cancer

Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach, with one quarter to one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. In patients who have a very good response to this treatment, survival following esophagectomy has increased, although the amount of increase has varied quite a bit between the different studies. Older studies have used the drugs Cisplatin and 5-fluoruracil. Although this combination of drugs has been beneficial, we wish to use a newer combination of drugs which may be more effective for esophageal cancer. The chemotherapy drugs used in this study are Cisplatin and Irinotecan. We also want to find out what side effects these drugs cause when given with radiation, and how often these side effects occur.

Read the detailed description

Historical surgical series have reported that the chance of cure with surgery alone is approximately one in four. Many phase II studies and some phase III studies have examined the role of induction (preoperative) chemotherapy and radiation. In general, these studies have demonstrated a trend to improved survival using an induction regimen with one phase III study reporting a significant improvement in survival. Two meta-analyses have failed to demonstrate a clear advantage of an induction regimen.

When these trials are reviewed, it is apparent that there is a subgroup of patients who are found at the time of resection to have had a complete pathological response to their treatment, and these patients clearly experience improved survival.

These previous trials have used older chemotherapy agents. Nevertheless, cisplatin remains one of the most active drugs available for treating solid tumours. Irinotecan is a newer drug that has demonstrated significant activity in colorectal cancer and more recently in esophageal cancer. A previous single institution trial of cisplatin and irinotecan in esophageal cancer demonstrated a significant response and acceptable toxicity.

By giving one cycle of chemotherapy alone first, it is expected that the dysphagia usually experienced by these patients will improve sufficiently and that nutritional support, i.e. feeding tube, will not be required (as has been demonstrated in a previous study of this drug combination). The same drugs will then be given concurrently with external beam radiation in order to take advantage of the radiosensitizing properties of both these drugs.

This will be followed by a boost dose of radiation, which will provide a total dose in the tumourcidal range. Surgery will follow the boost dose of radiation.

This study proposes to combine two drugs with demonstrated activity in esophageal cancer, cisplatin and Irinotecan, with radiation prior to surgery, with the hypothesis that these more active agents will offer better control of distant metastatic disease. Their radiosensitizing properties, when combined with radiation, will improve local control and provide an increased rate of pathological complete response in patients with surgically resectable esophageal cancer.

Being tested
Irinotecan hydrochloride trihydrate, Cisplatin
Keywords
esophageal, esophagus, irinotecan, CPT11, 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.

  • Irinotecan hydrochloride trihydrateDrug

    Irinotecan (65mg/m2) weeks 1-2, 4-5, 7-8

  • CisplatinDrug

    Cisplatin (30 mg/m2) weeks 1-2, 4-5, 7-8

Study groups in NCT00160875
Study groupRoleWhat they receive
Cisplatin, IrinotecanExperimentalNot described
Receives: Drug: Irinotecan hydrochloride trihydrate; Drug: Cisplatin

What is being measured

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

  1. pathological complete response

    Measured: 1 day

Secondary outcomes (9)

  1. acute and late toxicities

    Measured: 5 yrs

  2. postoperative mortality

    Measured: 1 month

  3. disease free survival

    Measured: 5 yrs

  4. overall survival

    Measured: 5 yrs

  5. Quality of life (FACT-E)

    Measured: 5 yrs

  6. clinical complete response rate

    Measured: 2 months

  7. tumor microvessel density (pathological)

    Measured: 1 day

  8. perfusion CT parameters (radiological)

    Measured: 2 months

  9. PET scan parameters (radiological)

    Measured: 2 months

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 startApr 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00160875
Sponsor's protocol ID
02-0484-C
Status last verified
May 2017
First submitted
8 Sep 2005
Last updated
4 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Irinotecan hydrochloride trihydrate and Cisplatin in people with Esophageal Cancer, run by University Health Network, Toronto at 1 site in Canada.

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 16 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 4 May 2017. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

pathological complete response (time frame: 1 day). 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 NCT00160875.

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 4 May 2017.

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