Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

Conditions

• Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cisplatin — DRUG
  Given IV
• docetaxel — DRUG
  Given IV
• gemcitabine hydrochloride — DRUG
  Given IV
• pemetrexed disodium — DRUG
  Given IV
• vinorelbine tartrate — DRUG
  Given IV
• standard follow-up care — PROCEDURE
  Standard care

Study Details

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

Key Dates

Start date

Mar 31, 2009

Status verified

Feb 2017

Primary completion

Nov 30, 2011

Completion

Nov 30, 2012

Study Design

Enrollment

34 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I
  Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II
  Patients receive standard care (observation).

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 12 years ]

Locations (93)

Find similar trials in Anniston, AL

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