Clinical trial · Interventional

Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

Multimodality Therapy for Stages II and III Non-Small Cell Lung Cancer: Surgical Resection Followed by Sequential Administration of Gemcitabine Plus Cisplatin Chemotherapy and Radiation Therapy

NCT00530634CI-TRIAL-00019647terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Poor accrual

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine, cisplatin, and radiation therapy works in treating patients with stage II or stage III non-small cell lung cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (8)

Intervention	Type	Mapped drug	Match
adjuvant therapy	Procedure	—	UNRESOLVED
cisplatin	Drug	Cisplatin	ALIAS
conventional surgery	Procedure	—	UNRESOLVED
gemcitabine hydrochloride	Drug	Gemcitabine	ALIAS
gene expression analysis	Genetic	—	UNRESOLVED
immunohistochemistry staining method	Other	—	UNRESOLVED
radiation therapy	Radiation	—	UNRESOLVED
reverse transcriptase-polymerase chain reaction	Genetic	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Gemcitabine + Cisplatin
description
Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
interventionNames
1. Drug: cisplatin
2. Drug: gemcitabine hydrochloride
3. Genetic: gene expression analysis
4. Genetic: reverse transcriptase-polymerase chain reaction
5. Other: immunohistochemistry staining method
6. Procedure: adjuvant therapy
7. Procedure: conventional surgery
8. Radiation: radiation therapy

Primary outcomes (1)

measure
Two-year Progression-free Survival From the Date of Surgery
timeFrame
2 years post-surgery
description
Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed single, primary bronchogenic non-small cell lung cancer meeting the following subtypes:

  * Adenocarcinoma (no bronchioalveolar cell histology)
  * Squamous cell carcinoma
  * Large cell carcinoma
* Meeting the following staging criteria:

  * Stage IIB (T2, N1, M0, or T3, N0, M0)
  * Stage IIIA (T1-3, N2, M0 or T3, N1, M0)
  * Stage IIIB (Any T, N3, M0 or T4, Any N, M0)
* No more than 1 parenchymal lesion in the same lung or in both lungs
* No tumor involving the superior sulcus (e.g., Pancoast tumor)
* Patients must undergo evaluation by the involved thoracic surgeon, medical oncologist, and radiation oncologist prior to registration
* No evidence of metastatic disease

  * Biopsy or aspiration cytology required to confirm the benign diagnosis of CT or MRI abnormalities that potentially represent metastatic disease
  * Biopsy required if all noninvasive tests are indeterminant

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Absolute granulocyte count ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Bilirubin ≤ 3 times upper limit of normal (ULN)
* SGOT and SGPT ≤ 3 times ULN
* Creatinine clearance \> 50 mL/min
* No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or any other cancer from which the patient has been disease-free for 5 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective protection
* No significant hearing loss or patient unwilling to accept potential for further hearing loss
* No uncontrolled medical illness by appropriate medical therapy (e.g., myocardial infarction within the past 3 months or liver cirrhosis)
* No symptomatic peripheral neuropathy affecting activities of daily living

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy for lung cancer

References

Publications (0)

Data not yet available

No reference posted for this study.