COMPARISON OF 2 CHEMOTHERAPY REGIMENS IN NON SMALL CELL LUNG CANCER PATIENTS RELAPSING AFTER SURGERY AND PERI OPERATIVE CHEMOTHERAPYA RANDOMIZED PHASE III STUDY.

• Conditions: [1]Patients with histologically or cytologically confirmed inoperable non-small cell-lung cancer not eligible for curative radio-therapy (local or metastatic relapse).[2] Previous history of adjuvant or neoadjuvant chemotherapy (at least 2 full cycles of a platinum containing regimen) (maximum dose of cisplatin 320 mg/m2, No maximum dose of carboplatin)

• Registration Number: EUCTR2007-001997-97-FR
• Lead Sponsor: IFCT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-24
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

[1]Patients with histologically or cytologically confirmed inoperable non-small cell-lung cancer not eligible for curative radio-therapy (local or metastatic relapse).
[2] Previous history of adjuvant or neoadjuvant chemotherapy (at least 2 full cycles of a platinum containing regimen) (maximum dose of cisplatin 320 mg/m2, No maximum dose of carboplatin)
[3] pTNM initial stage pT1N0 to pT3N2, complete resection. T4 tumours (2 nodules in the same lobe) N0-2 completely resected are allowed to inclusion.
[4]At least one unidimensionally measurable disease (RECIST criteria) (lesions must have clearly defined margins on X-ray, CT-scan, MRI or ultra-sound (US) examination and should measure at least 1 cm if assessed by CT, MRI or US and at least 2 cm if assessed by X-ray, target lesions should be selected outside a previously iradiated field ). PET scans and ultra sonography are not allowed
[5]ECOG Performance status 0 to 1).
[6]Patients aged equal or more than 18 years or equal or less than 75 years.
[7] Patients with adequate biological functions
[8] Written informed consent from patient.
[9] The effects of docetaxel and cisplatin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because docetaxel and cisplatin as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
[10] Life expectancy ? 12 weeks
[11]Patient compliance and geographic proximity that allow adequate follow-up.
[12] Patient affiliated to a social insurance program

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[13] Previous treatment with docetaxel.

[14] Hypersensitivity to docetaxel, cisplatin or polysorbate 80 (excipient).

[15] Previous history of cancer other than Non small cell lung cancer, in situ carcinoma of the uterine cervix and basal cell carcinoma of the skin.

[16] Patients previously treated by an investigational agent in the last 30 days.

[17] Patients with a peripheral neuropathy grade CTC ? 1

[18] Patients unable to fulfil protocol requirements

[19] Serious concomitant morbidity incompatible with the study (at the discretion of the investigator).

[20] Patients with a severe heart disease (class III, IV NYHA) such as symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the last 6 months.

[21] Relapse within the month following lung cancer resection or adjuvant chemotherapy

[22] Other clinically detectable cancer other than NSCLC at the time of selection

[23] Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

[24] Significative loss of weight (? 10 %) in the 6 weeks preceding patient selection.

[25] Concomitant administration of another anti cancer treatment

[26] Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.

[27] Patient under legal protection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the best chemotherapy option in progressive disease patients initially treated with perioperative chemotherapy and surgery<br>Progression free survival will be the end point of this 2 arms study:<br>• docetaxel alone<br>• docetaxel cisplatin<br>;Secondary Objective: Tumour response rate at 6 weeks (RECIST criteria)<br>Treatment related toxicity (NCI CTC)<br>Overall survival<br>Quality of life (quality of life adjusted survival QUALY and EORTC QLQ C30 LC13 module)<br>Pharmacogenomic and molecular profiling<br>;Primary end point(s): Principal evaluation criteria is progression free survival.