AzTrials
AzTrials

Locally Advanced Non-small Cell Lung CancerPhase 2TAXCISNCT03371550

A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy

A Phase 2 study testing Docetaxel, concomitant radiotherapy and Cisplatin in people with Locally Advanced Non-small Cell Lung Cancer, run by Centre Antoine Lacassagne.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced stage III non-small cell lung cancer. However, the optimal combination remains unclear. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Docetaxel, concomitant radiotherapy and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
No sites listed yet
Study dates
5 Aug 2004to 31 Oct 2011
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically or cytologically confirmed NSCLC,
  • stage IIIB (excluding malignant pleural or pericardial effusions, tumoral volume exceeding one radiation field,
  • N3 supraclavicular, and contralateral hilar nodal involvement) or inoperable stage IIIA defined by the new International Staging System [21],
  • 18 ≤ age ≤ 75 years,
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2,
  • weight loss <10%,
  • at least one measurable lesion according to RECIST 1.0 criteria,
  • adequate hematopoietic function (absolute neutrophil count ≥2 × 109/l, platelets ≥100 × 109/l, and hemoglobin level ≥10g/dl), adequate hepatic function [total serum bilirubin less than or equal to the institutional upper limit of normal (ULN), aspartate aminotransferase ≤1.5× ULN, and alkaline phosphatase ≤5× ULN], and adequate renal function (serum creatinine ≤1.5× ULN).

Who cannot join

  • patients previously treated with radiotherapy or chemotherapy for NSCLC,
  • previous cancer except basocellular carcinoma and in situ carcinoma of the cervix curatively treated and other cancers curatively treated for at least 5 years,
  • peripheral neuropathy NCI-CTC grade ≥2,
  • noncontroled severe disease,
  • pregnant or breast-feeding women.

About this study

Official title: Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Trial

Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced stage III non-small cell lung cancer. However, the optimal combination remains unclear. The aim of this study is to evaluate the efficacy of 2 induction chemotherapy cycles (days 1 and 22) with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 followed by concurrent chemotherapy (weekly docetaxel-cisplatin, 20 mg/m2) and 3-D conformal radiotherapy for 6 weeks (66 Gy/5 fractions per week/2 Gy per fraction). ). The primary endpoint is the response rate. Secondary objectives are toxicity, time to progression, and overall survival.

Read the detailed description

Lung cancer is the most common malignancy among men in most countries and constitutes the leading cause of cancer death worldwide. Non-small cell histology represents roughly 80% of lung cancer cases comprising one third of patients with stage III, locally-advanced disease at diagnosis. Some stage IIIA cancers are considered resectable but many stage IIIA (with bulky N2) and stage IIIB (T4 any N M0, any T N3M0) cancers are considered unsuitable for surgery. However, some authors have shown that surgery after chemoradiotherapy (CHRT) is beneficial for at least progression-free survival (PFS). Since the 90s, CHRT has become the cornerstone of inoperable locally advanced non-small cell lung cancer (NSCLC). A meta-analysis of 52 randomized studies showed a survival improvement of 3% at 2 years and 2% at 5 years for patients treated with CHRT versus radiotherapy alone [6]. Concomitant chemoradiation was demonstrated to be better than sequential administration in terms of overall survival (OS) in 3 out of 4 randomized studies with esophagitis as the dose-limiting toxicity. Nevertheless, the median survival was around 16 months and improvement is needed. To better control micrometastatic disease and reduce distant relapses, one possibility is to increase radiosensitization with higher doses of chemotherapy.The aim of this phase II study is to evaluate the anti-tumoral activity of a weekly docetaxel-cisplatin combination administered concurrently with radiotherapy after 2 induction cycles with the same drugs.

Being tested
Docetaxel, concomitant radiotherapy, Cisplatin
Keywords
Concurrent 3-D chemoradiotherapy,Docetaxel,Cisplatin,Chemotherapy ·

What participants receive

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

  • DocetaxelDrug

    Induction chemotherapy

  • concomitant radiotherapyRadiation

    Pulmonary and mediastinal radiotherapy

  • CisplatinDrug

    Induction chemotherapy

Study groups in NCT03371550
Study groupRoleWhat they receive
RadiochemotherapyExperimentalInduction chemotherapy with docetaxel and cisplatine and concomitant radiotherapy
Receives: Drug: Docetaxel; Radiation: concomitant radiotherapy; Drug: Cisplatin

What is being measured

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

  1. To evaluate the antitumor activity of Docetaxel - Cisplatin and concomitant thoracic radiotherapy after Docetaxel - Cisplatin induction chemotherapy in patients with locally advanced non-operable NSCLC by tumor response rate

    Tumor Response rate between 6 and 8 weeks according to RECIST 1.0 criteria after the end of radiotherapy (except in the case of early progression) that patients:

    • having received at least 4 weekly injections of Docetaxel and Cisplatin,
    • who have received the full radiotherapy treatment (except in case of cessation for toxicity, in which case the patients will be evaluable).

    Measured: up to 3 years

Secondary outcomes (5)

  1. Overall survival and at 12 months

    To evaluate the overall survival at 12 months between the first day of treatment to the death

    Measured: up to 3 years

  2. Response delay

    Complete response delay evaluated between the day of the complete response to the progression and partial response between the first day of the treatment and the progression

    Measured: up to 3 years

  3. Progression Free Survival

    To evaluate Progression free survival according to RECIST criteria

    Measured: up to 3 years

  4. Tolerance profile of the association in terms of immediate and delayed toxicity

    To evaluate early and late toxicity according to the NCI-CTC

    Measured: up to 3 years

  5. Quality of Life evaluation (EORTC QLQ-C30 and QLQ-LC13)

    To evaluate the quality of life at inclusion, at the end oh chemotherapy, 2 months after the radiotherapy and every 3 months until end of study

    Measured: up to 3 years

Timeline

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

  1. First posted13 Dec 2017
  2. Study start5 Aug 2004
  3. Primary completion31 Oct 2010
  4. Study completion31 Oct 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This was a prospective, open-label, multicentric, phase II study.
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03371550
Sponsor's protocol ID
2004/07
Acronym
TAXCIS
Status last verified
Nov 2017
First submitted
30 Nov 2017
Last updated
13 Dec 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, concomitant radiotherapy and Cisplatin in people with Locally Advanced Non-small Cell Lung Cancer, run by Centre Antoine Lacassagne.

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 8 inclusion and 5 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

To evaluate the antitumor activity of Docetaxel - Cisplatin and concomitant thoracic radiotherapy after Docetaxel - Cisplatin induction chemotherapy in patients with locally advanced non-operable NSCLC by tumor response rate (time frame: up to 3 years). 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 NCT03371550.

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 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in