Back to resultsCombined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Surgery
Chest Irradiation
Cisplatin
Etoposide
Prophylactic Cranial Irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- No previous treatment.
- Tumor must be resectable.
- >/= 18 and </= 70 years of age.
- Zubrod performance status </= or higher performance status if based only on pain.
- Must have adequate bone marrow, liver and renal function as defined in 3.6.
Exclusion Criteria:
- Cytological or histological proof of N3 disease.
- Evidence of metastatic disease to distant sites.
- Patients with impending cord compression will be ineligible.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery + Radiotherapy + Chemotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00984997
First Posted
September 24, 2009
Last Updated
June 29, 2016
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00984997
Brief Title
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
Official Title
Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 1993 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery + Radiotherapy + Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Segmentectomy or lobectomy with en bloc resection of the involved chest.
Intervention Type
Radiation
Intervention Name(s)
Chest Irradiation
Other Intervention Name(s)
Radiotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol, CDDP
Intervention Description
50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VePesid, VP-16
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Cranial Irradiation
Other Intervention Name(s)
PCI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy
Description
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.
Time Frame
Assessed from one month after completion of chemotherapy to year 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No previous treatment.
Tumor must be resectable.
>/= 18 and </= 70 years of age.
Zubrod performance status </= or higher performance status if based only on pain.
Must have adequate bone marrow, liver and renal function as defined in 3.6.
Exclusion Criteria:
Cytological or histological proof of N3 disease.
Evidence of metastatic disease to distant sites.
Patients with impending cord compression will be ineligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritsuko Komaki, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
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