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

NCT00984997 | Completed Phase 2

• 1 other identifier: ID92-038
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed from one month after completion of chemotherapy to year 10

Study Arms (1)

Surgery + Radiotherapy + Chemotherapy

EXPERIMENTAL

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; Radiation: Chest Irradiation; Drug: Cisplatin; Drug: Etoposide; Radiation: Prophylactic Cranial Irradiation

Interventions

Surgery PROCEDURE

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

Surgery + Radiotherapy + Chemotherapy

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.

Also known as: Radiotherapy

Surgery + Radiotherapy + Chemotherapy

Cisplatin DRUG

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

Also known as: Platinol, CDDP

Surgery + Radiotherapy + Chemotherapy

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.

Also known as: VePesid, VP-16

Surgery + Radiotherapy + Chemotherapy

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.

Also known as: PCI

Surgery + Radiotherapy + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cytological or histological proof of N3 disease.
• Evidence of metastatic disease to distant sites.
• Patients with impending cord compression will be ineligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Pancoast Syndrome

Interventions

Surgical Procedures, Operative; Radiotherapy; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ritsuko Komaki, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: October 1, 1993
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2015
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

US (1)