Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00984997
First received: September 24, 2009
Last updated: October 1, 2012
Last verified: October 2012

September 24, 2009
October 1, 2012
October 1993
January 2014   (final data collection date for primary outcome measure)
Patient Outcomes Following Surgery and Accelerated Radiation Therapy/Chemotherapy [ Time Frame: One month after completion of chemotherapy ] [ Designated as safety issue: No ]
To find if surgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy will give better controls at the primary location and/or distant metastatic site. [ Time Frame: One month after completion of chemotherapy. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00984997 on ClinicalTrials.gov Archive Site
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Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
  1. To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy.
  2. To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Procedure: Surgery
    Segmentectomy or lobectomy with en bloc resection of the involved chest.
  • Radiation: Chest Irradiation
    Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week.
    Other Name: Radiotherapy
  • Drug: Cisplatin
    50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.
    Other Names:
    • Platinol
    • CDDP
  • Drug: Etoposide
    given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29.
    Other Names:
    • VePesid
    • VP-16
  • Radiation: Prophylactic Cranial Irradiation
    25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.
    Other Name: PCI
Experimental: Surgery + Radiotherapy + Chemotherapy

Surgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy. Segmentectomy or lobectomy with en bloc resection of the involved chest. Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week. Cisplatin 50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.

Etoposide given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29. Prophylactic Cranial Irradiation 25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.

Interventions:
  • Procedure: Surgery
  • Radiation: Chest Irradiation
  • Drug: Cisplatin
  • Drug: Etoposide
  • Radiation: Prophylactic Cranial Irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
47
Not Provided
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. No previous treatment.
  2. Tumor must be resectable.
  3. >/= 18 and </= 70 years of age.
  4. Zubrod performance status </= or higher performance status if based only on pain.
  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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984997
ID92-038
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Ritsuko Komaki, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP