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Completed

NCT Number: NCT00984997

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancoast Syndrome Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery

Procedure

Segmentectomy or lobectomy with en bloc resection of the involved chest.

Chest Irradiation

Radiation

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 names: Radiotherapy

Cisplatin

Drug

50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.

Other names: Platinol, CDDP

etoposide

Drug

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

Prophylactic Cranial Irradiation

Radiation

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 names: PCI

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
1993
Primary completion
2007
Study completion
2015
First posted
Sep 25, 2009
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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