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Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.

Phase 3
18 Years
75 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.

As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC,
particularly in the adjuvant and neoadjuvant setting, physicians face a growing population
of high performance status patients who have relapsed after their first-line chemotherapy.
The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a
platinum-based regimen remains largely undefined. Some might consider rechallenging patients
with a platinum based doublet whereas others might treat these patients with a
monochemotherapy (pemetrexed or docetaxel).

Most relapses occurring after perioperative chemotherapy and surgery are non surgical
locally advanced relapses or metastatic diseases.

Some differences exist between these post surgical relapses and the progressions occurring
after the first line non surgical treatment of a stage III/IV.

- Patients are most often in a good condition (performance status 0-1).

- Progression is often asymptomatic and diagnosed in the post surgical follow up.

- The dose of chemotherapy previously administered is lower than that administered in
first line of a stage III/IV.

- The time between the first line of treatment and the treatment of the relapse is

These differences might be associated with a more chemosensitive disease and thus might be
the rationale of using a platinum containing doublet instead of the classical mono
chemotherapy docetaxel or pemetrexed.

Thus, the current study has been designed to answer these questions.

Inclusion Criteria:

- Patients with histologically or cytologically confirmed inoperable non-small
cell-lung cancer not eligible for curative radio-therapy (local or metastatic

- Previous history of adjuvant or neoadjuvant chemotherapy (at least 2 full cycles of a
platinum containing regimen)

- Initial stage pT1N0 to pT3N2 (TNM classification 1999), complete resection. T4
tumours (several nodules in the same lobe) and M1 tumours (several nodules in the
same lung) N0-2 completely resected are allowed to inclusion. Histological complete
response tumours (pT0N0) after neoadjuvant chemotherapy are allowed to inclusion.

- 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 irradiated
field ). PET scans and ultra sonography are not allowed

- ECOG Performance status 0 to 1).

- Patients with adequate biological functions:

- Written informed consent from patient.

- The effects of docetaxel, cisplatin and carboplatin on the developing human fetus at
the recommended therapeutic dose are unknown. For this reason and because docetaxel,
cisplatin and carboplatin 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.

- Life expectancy > 12 weeks

- Patient compliance and geographic proximity that allow adequate follow-up.

- Patient affiliated to a social insurance program

Exclusion Criteria:

- Previous treatment with docetaxel.

- Hypersensitivity to docetaxel, cisplatin, carboplatin or polysorbate 80 (excipient).

- 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.

- Patients previously treated by an investigational agent in the last 30 days.

- Patient treated with preoperative platin based chemotherapy, achieving a progression
of disease after treatment evaluation.

- Patients non responders to preoperative chemotherapy and whose tumor specimen did not
disclose any necrosis nor tumoral modification thus confirming the lack of
chemosensitivity to platin based chemotherapy

- Patient treated with platin based adjuvant chemotherapy, relapsing within the first 6
months after surgery.

- Patients with a peripheral neuropathy grade CTC >= 2

- Patients unable to fulfill protocol requirements

- Serious concomitant morbidity incompatible with the study (at the discretion of the

- Relapse within the month following lung cancer resection or adjuvant chemotherapy

- 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

- Significant loss of weight (> 10 %) in the 6 weeks preceding patient selection.

- Concomitant administration of another anti cancer treatment

- 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.

- Patient under legal protection.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival (PFS)

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Denis Moro-Sibilot, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Grenoble


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2007

Completion Date:

August 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • NSCLC relapse after adjuvant chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung