Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

Hellenic Oncology Research Group

Status and phase: Terminated; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Docetaxel; Radiation: Chemoradiotherapy; Drug: Gemcitabine; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00431613

CT/04.26

Details and patient eligibility

About

The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.

Full description

To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage regarding time to tumor progression

Enrollment: 38 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically or cytologically confirmed, unresectable locally advanced (stage IIIA/IIIB) NSCLC
• no previous therapy for NSCLC is allowed
• age >18 years
• bidimensionally measurable disease
• performance status (WHO) 0-2
• absence of pleural effusion
• adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
• life expectancy of more than 3 months
• written informed consent

Exclusion criteria

• active infection
• history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• malnutrition (loss of ≥ 20% of the original body weight)
• performance status: 3-4
• sensor or motor neuropathy > grade I
• second primary malignancy, except for non-melanoma skin cancer
• psychiatric illness or social situation that would preclude study compliance
• pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Experimental group

Description:

DG -\> RT

Treatment:

Drug: Docetaxel

Drug: Docetaxel

Drug: Gemcitabine

Radiation: Chemoradiotherapy

2

Experimental group

Description:

DG -\> RT -\> DCarbo

Treatment:

Drug: Docetaxel

Drug: Docetaxel

Drug: Gemcitabine

Radiation: Chemoradiotherapy

Drug: Carboplatin