Stage I/II NSCLC Perioperative Chemotherapy

Intergroupe Francophone de Cancerologie Thoracique

Status and phase: Completed; Phase 3

Conditions: Peri-operative Chemotherapy; Non-small Cell Lung Cancer Stage I and II

Treatments: Drug: Paclitaxel + Carboplatine; Drug: gemcitabine + cisplatine

Study type: Interventional

Funder types: Other

Identifiers

NCT00198354

IFCT-0002

Details and patient eligibility

About

The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.

Full description

In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.

Enrollment: 530 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less

Exclusion criteria

NSCLC stage III or IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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530 participants in 4 patient groups

A: pre-operative chemotherapy

Experimental group

Description:

pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)

Treatment:

Drug: gemcitabine + cisplatine

B: pre-operative chemotherapy

Experimental group

Description:

pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)

Treatment:

Drug: gemcitabine + cisplatine

C: peri-operative chemotherapy

Experimental group

Description:

peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)

Treatment:

Drug: Paclitaxel + Carboplatine

D: peri-operative chemotherapy

Experimental group

Description:

peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)

Treatment:

Drug: Paclitaxel + Carboplatine