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

First listed

Oct 27, 2014

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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