Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)

Browse trials for

• Lung Neoplasms 7,243
• Carcinoma, Non-Small-Cell Lung 6,488

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  Gemcitabine

  Drug: gemcitabine · Drug: cisplatin · Drug: etoposide · Radiation: radiation therapy

• Experimental
  Gemcitabine plus Docetaxel

  Drug: gemcitabine · Drug: docetaxel · Drug: cisplatin · Drug: etoposide · Radiation: radiation therapy

Interventions

• Druggemcitabine

  After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.

  Also known as: LY188011, Gemzar

• Drugdocetaxel

  Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

  Also known as: Taxotere

• Drugcisplatin

  As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)

  Also known as: Platinol, Platinol-AQ, CDDP

• Drugetoposide

  As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)

  Also known as: Toposar®, VePesid®, Etopophos®, VP-16, Etoposide phosphate

• Radiationradiation therapy

  In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks

Primary outcomes

1. 2-Year Survival

   Percentage of participants alive at 2 years.

   Time frame: 2 years

Secondary outcomes

1. Number of Patients With Overall Tumor Response

   Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).

   Time frame: randomization and every 3 months up to 2 years of post-study followup

2. Progression-Free Survival

   Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.

   Time frame: baseline to measured progressive disease up to 2057 days

3. Overall Survival

   Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.

   Time frame: baseline to date of death from any cause up to 2057 days

4. Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization

   LCSS measures physical \& functional dimensions. The patient scale contains 9 items, 3 summation \& 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.

   Time frame: baseline to 3 months after last dose of study treatment (three 21-day cycles)

Baseline characteristics