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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

  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.

Detailed Summary:

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.


Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy [ Time Frame: Assessed from one month after completion of chemotherapy to year 10 ]

Locoregional control (LRC) defined as disease non-recurrence in a localized area for patients with resectable superior sulcus tumors treated with surgical resection followed by adjuvant chemoradiation. LRC measured as percentage of participants without recurrence at rates of local control as measured Years 2, 5, and 10.


Original Primary Outcome: 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. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: September 24, 2009
Date Started: October 1993
Date Completion:
Last Updated: June 29, 2016
Last Verified: June 2016