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 9, 2013
Last verified: October 2013
  Purpose
  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.

Condition Intervention Phase
Lung Cancer
Procedure: Surgery
Radiation: Chest Irradiation
Drug: Cisplatin
Drug: Etoposide
Radiation: Prophylactic Cranial Irradiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Outcomes Following Surgery and Accelerated Radiation Therapy/Chemotherapy [ Time Frame: One month after completion of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: October 1993
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984997

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ritsuko Komaki, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00984997     History of Changes
Other Study ID Numbers: ID92-038
Study First Received: September 24, 2009
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Lung Neoplasms
Pancoast Syndrome
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014