Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC

Conditions

• Lung Neoplasms, Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan — DRUG
• Cisplatin — DRUG

Study Details

This is a prospective, single institution phase II study, whose primary objective is to estimate the median and three year survival rate of non-small lung cancer patients with Stage IIIA and IIIB intra-thoracic disease which is referred to as "locally advanced" non-small cell lung cancer (NSCLC).

Key Dates

Start date

Oct 31, 2014

Status verified

Oct 2018

Primary completion

Sep 27, 2017

Completion

Sep 27, 2017

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: All enrolled patients
  Induction Chemotherapy Cycle 1 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 1 and 8 Concurrent Chemotherapy Cycles 2-4 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 22 and 29, days 43 and 50, and days 64 and 71 along with radiation therapy of 60-70 Gy in 2 GY fractions on days 22 -71.

Primary Outcome Measure

Estimate the median and three year survival rate of locally advanced NSCLC using the platinum doublet cisplatin and irinotecan [ Time Frame: Three years after the last patient has completed treatement ]

Locations (1)

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