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Non-Small-Cell Lung CarcinomaPhase 1/2NCT00379717

Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

A Phase 1/2 study testing Cisplatinum, Docetaxel and Tomotherapy in people with Non-Small-Cell Lung Carcinoma, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This non-randomized Phase I/II study is designed to determine the maximum tolerated dose (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in patients with LA-NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small-Cell Lung Carcinoma
What is being tested?
Cisplatinum, Docetaxel and Tomotherapy
Type of treatment
Medical device
How many people
30 participants
Where
1 siteBelgium
Study dates
Nov 2006to Apr 2008
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent is required.
  • Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
  • Patients must have a stage III unresectable LA-NSCLC:
  • Males or females aged between 18 and 75 years.
  • Life expectancy of at least 12 weeks.
  • ECOG performance status 0,1 or2.
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  • Weight loss ≤ 10% within the last 3 months.
  • Laboratory requirements at entry:
  • Blood cell counts: i. Absolute neutrophils ≥ 2.0 x 109/L ii. Platelets ≥ 100 x 109/L iii. Haemoglobin ≥ 11 g/dl
  • Renal function: i. Serum creatinine < 1 x the upper limit of normal (UNL). ii. In case of borderline value of serum creatinine, the 24h creatinine clearance should be > 60 ml/min.
  • Hepatic function: i. Serum bilirubin < 1 x UNL ii. ASAT and ALAT < 2.5 x UNL iii. alkaline phosphatase < 5 x UNL iv. Patient with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL is not eligible for the study.
  • Lung function tests at entry:
  • FEV1: ≥ 50 % x Normal value
  • DLCO: ≥ 50 % x Normal value
  • Adequate cardiac function.
  • Patient with either measurable and/or non-measurable lesion (according to RECIST criteria, A1).

Who cannot join

  • Diagnosis of small cell lung cancer.
  • Stage IIIB NSCLC, based on the presence of malignant pleural or pericardial effusion.
  • Pregnant or lactating women.
  • Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
  • Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC.
  • Prior surgery for NSCLC, if less than 5 years from study.
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  • Prior radiotherapy for NSCLC.
  • History of prior malignancy, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
  • Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.
  • Other serious concomitant illness or medical conditions:
  • Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
  • History of significant neurological or psychiatric disorders including dementia or seizures.
  • Active infection requiring IV antibiotics.
  • Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
  • Superior vena cava syndrome contra-indicating hydration.
  • Pre-existing pericardial effusion.
  • Pre-existing symptomatic pleural effusion.
  • Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
  • Distant metastasis.
  • Concurrent treatment with any other experimental anti-cancer drugs.
  • Concomitant or within 4-week period administration of any other experimental drug under investigation.
  • Significant ophthalmologic abnormalities.
  • Moderate to severe dermatitis.
  • Hypersensitivity to docetaxel, cisplatin, or any of its excipients.
  • Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.

Trial locations and contacts

1 site in 1 country.

Samuel Bral, MD contact

003224776415

samuel.bral@uzbrussel.be

Nicolas Fontaine, Mr contact

0032 2 477 54 61

nicolas.fontaine@uzbrussel.be

Belgium1 site, 1 recruiting

  • UZ Brussel

    Jette, 1090

    Samuel Bral, MD, 0032 2 477 64 15, samuel.bral@uzbrussel.be

    Nicolas Fontaine, Mr, 0032 2 477 54 61, nicolas.fontaine@uzbrussel.be

    Recruiting

Other trials in Belgium

About this study

Official title: Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): a Phase I/II Trial of Radiation Dose Escalation and Fixed Dose Chemotherapy.

This non-randomized Phase I/II study is designed to determine the maximum tolerated dose (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in patients with LA-NSCLC. All patients will receive weekly administrations of docetaxel 20 mg/m² and cisplatin 20 mg/m2 concurrently with radiotherapy. Radiotherapy will be delivered using helical tomotherapy in 30 daily fractions over six weeks. Patients should have recovered fully from induction concurrent chemoradiotherapy before they continue with the consolidation chemotherapy phase. Patients will be entered in cohorts of at least 5 subjects.

The first cohort of patients will receive 30 fractions of 2Gy in six weeks up to a total dose of 60Gy. The concurrent chemotherapy starts at day 1 of the radiotherapy and will be administered 2-4 hours before the radiotherapy.

The radiotherapy fraction size will be escalated to 2.36Gy in three steps.

Read the detailed description

Dose escalation steps are:

30*2.00Gy = 60.0Gy (BED= 70.8Gy10 NID2= 60.0Gy) 30*2.12Gy = 63.6Gy (BED= 75.9Gy10 NID2= 64.2Gy) 30*2.24Gy = 67.2Gy (BED= 81.5Gy10 NID2= 68.5Gy) 30*2.36Gy = 70.8Gy (BED= 86.3Gy10 NID2= 72.9Gy) If MTD is not reached, protocol modification allowing further escalation can be considered.

Being tested
Cisplatinum, Docetaxel, Tomotherapy
Keywords
helical tomotherapy, dose escalation, chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CisplatinumDrug

  • DocetaxelDrug

  • TomotherapyDevice

What is being measured

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

  1. To evaluate the feasibility and toxicity of radiation dose escalation using helical tomotherapy concurrently with chemotherapy (docetaxel-cisplatin combination) in stage III locally advanced non small cell lung cancer (LA-NSCLC).

Secondary outcomes (1)

  1. To estimate efficacy parameters in terms of overall response rate, progression free survival and overall survival. To monitor quality of life (QOL) before, during and after treatment.

Timeline

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

  1. First posted22 Sep 2006 (estimated)
  2. Study startNov 2006
  3. Study completionApr 2008

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379717
Sponsor's protocol ID
VUB06-001
Other IDs
TomoCT
Status last verified
Sep 2006
First submitted
21 Sep 2006
Last updated
13 Mar 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cisplatinum, Docetaxel and Tomotherapy in people with Non-Small-Cell Lung Carcinoma, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

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 16 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 13 Mar 2008. 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 Belgium. 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?

Contact Samuel Bral, MD (003224776415, samuel.bral@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the feasibility and toxicity of radiation dose escalation using helical tomotherapy concurrently with chemotherapy (docetaxel-cisplatin combination) in stage III locally advanced non small cell lung cancer (LA-NSCLC).. 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 NCT00379717.

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 13 Mar 2008.

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