Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy (PLANET)

Ass. Prof. Jan Nyman

Status and phase: Terminated; Phase 2

Conditions: Non Small Cell Lung Cancer; Locally Advanced Disease

Treatments: Radiation: Standard radiochemotherapy to 68 Gy; Radiation: Dose escalated radiochemotherapy up to 84 Gy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01664663

PLANET

Details and patient eligibility

About

The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.

Full description

This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological diagnosis of NSCLC stage IIIA-B.
• Nonresectable or medically inoperable patients.
• No prior chemo- or radiotherapy for NSCLC.
• PS 0-1.
• FEV1 > 1 l or > 40% and CO diffusion capacity > 40%.
• Patient compliance and geographic proximity that allow adequate follow-up.
• Adequate bone marrow reserve: WBCC >3.0, platelets >100, haemoglobin > 100.
• Written informed concent.
• Effective use of contraception.

Exclusion criteria

• Excessive weight loss within 6 months (> 10%).
• Supraclavicular nodes.
• Apical tumors-pancoast.
• T4 tumors with separate manifestations in different lobes.
• Evidence of active serious infections.
• Inadequate liver function.
• Inadequate kidney function.
• Pregnancy.
• Breast feeding.
• Serious concomitant systemic disorder.
• Second primary malignancy the last 5 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Arm A:Standard radiochemotherapy

Active Comparator group

Description:

Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation.

Treatment:

Radiation: Standard radiochemotherapy to 68 Gy

Arm B Escalated radiochemotherapy

Experimental group

Description:

Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation.

Treatment:

Radiation: Dose escalated radiochemotherapy up to 84 Gy