Know Cancer

or
forgot password

Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors


Eligible (surgically resectable and medically operable) patients will have surgery followed
by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2
weeks for positive margins. Grossly positive margins can be treated by brachytherapy
followed by external radiotherapy.

Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and
etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10
days. The cycle will be repeated start day 29.

If the patients are considered to have no evidence of disease in one month after completion
of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10
fractions once daily for 2 weeks.


Inclusion Criteria:



1. No previous treatment.

2. Tumor must be resectable.

3. >/= 18 and
4. Zubrod performance status
5. Must have adequate bone marrow, liver and renal function as defined in 3.6.

Exclusion Criteria:

1. Cytological or histological proof of N3 disease.

2. Evidence of metastatic disease to distant sites.

3. Patients with impending cord compression will be ineligible.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Outcomes Following Surgery and Accelerated Radiation Therapy/Chemotherapy

Outcome Time Frame:

One month after completion of chemotherapy

Safety Issue:

No

Principal Investigator

Ritsuko Komaki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID92-038

NCT ID:

NCT00984997

Start Date:

October 1993

Completion Date:

Related Keywords:

  • Lung Cancer
  • Superior Sulcus Tumor
  • Lung Cancer
  • Non-Small Cell
  • Multimodality Treatment
  • Surgery
  • Segmentectomy
  • Lobectomy
  • Cisplatin
  • CDDP
  • Etoposide
  • VP-16
  • VePesid
  • Radiation Therapy
  • Radiotherapy
  • Chest Irradiation
  • Prophylactic Cranial Irradiation
  • PCI
  • Lung Neoplasms
  • Pancoast Syndrome

Name

Location
U.T. M.D. Anderson Cancer Center Houston, Texas  77030