PROCLAIM: A Phase III Study of Pemetrexed, Cisplatin, and Radiation Therapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiation Therapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Locally Advanced Stage III Non–Small-Cell Lung Cancer of Other than Predominantly Squamous Cell Histology

PROCLAIM Phase III Study

Everett E. Vokes; Suresh Senan; Joseph A. Treat; Neill A. Iscoe

Disclosures

Clin Lung Cancer. 2009;10(3):193-198. 

In This Article

Treatment Plan

Patients in this global trial will be stratified based on performance status, sex, stage, and PET scan use and will be randomized in a 1:1 ratio to either the pemetrexed regimen or the control arm, as shown in Figure 1.

Figure 1.

Design of the PROCLAIM study.

Patients on the pemetrexed arm will be scheduled to receive 3 cycles of pemetrexed and cisplatin at doses of 500 mg/m2 and 75 mg/m2 respectively on days 1, 22, and 43 of radiation, to be followed after a 3-5 week recovery from the completion of radiation by consolidation therapy with pemetrexed 500 mg/m2 every 21 days for 4 cycles. Patients on the control arm will receive chemotherapy with etoposide 50 mg/m2 days 1-5 and 29-33 and cisplatin 50 mg/m2 days 1, 8, 29, and 36 of radiation therapy. Following the 3-5 week recovery after radiation, patients will commence 1 of 3 platinum doublet therapy consolidation programs for a maximum of 2 cycles of a regimen of their physician’s choice: etoposide and cisplatin as given with radiation; vinorelbine and cisplatin at doses of 30 mg/m2 days 1, 8, 22, and 29 with cisplatin 75 mg/m2 days 1 and 22; or paclitaxel at dose of 200 mg/m2 and carboplatin (AUC = 6) both on days 1 and 22.

All patients will be scheduled to receive 66 Gy in 33 fractions only to known disease (‘involved fields’) administered 5 days weekly. All patients should have at least 3-dimensional radiation treatment plans. Four-dimensional CT imaging and use of strategies to account for tumor motion will be permitted.

Following completion of therapy, patients will commence scheduled follow-up at 6, 9, and 12 months from study entry; every 4 months during year 2; and every 6 months from years 3-5. Computed tomography scans of the chest and abdomen will be obtained with each visit and pulmonary function tests performed at 6, 12, and 24 months.

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