Clinical Trials

The Division of Thoracic Surgery is actively involved in clinical research and offers a number of trials to its patients which are aimed at improving survival and quality of life for almost every stage of lung cancer. The Division also offers the newest treatment protocols for mesothelioma and esophageal cancer. The multi-institution trials are approved and funded by the National cancer Institute, and our in-house studies, which are written by investigators within the Division, are approved by our internal Scientific Review and Human Protection Committees. Through the active pursuit and participation in these clinical trials, our investigators can offer patients treatment options that involve the newest therapies, staging techniques, and multimodality treatment plans.

Clinical research is a high priority of the Division because it offers the possibility and provides the data for the comparison of novel therapies to the standard of care.

For more information on these studies please refer to the contacts listed.

The studies open and available to patients within the Division of Thoracic Surgery include the following:

CALGB 9633: A Phase III Study of Adjuvant Chemotherapy After Resection For Patients with T2N0 Stage 1 NSCLC

This is a randomized study in which patients who have early stage lung cancer are assigned by chance to one of two treatment arms. After resection of the lung tumor, patients will go onto either chemotherapy (Taxol and Carboplatin) or observation alone.

As many as 50% of clinical and 30-40% of surgical-pathological stage I patients have their cancer come back after surgery, thus selected Stage I patients (T2N0) represent an obvious target for adjuvant treatment trials. The objective of this study is to determine if adjuvant chemotherapy can favorably alter the prognosis of this subgroup of Stage I patients who, following complete surgical resection of their disease, are defined as "high risk" on the basis of T status classification in the TNM system of the International Staging System.

02-225 Supportive and Educational Intervention for Elderly Lung Cancer Patients

FOR: Patients over the age of 70, who are undergoing chest operations for suspected or proven lung cancer.
WHY? To investigate what effect your surgery has on you and your family, including changes in: your ability to be independent, your mood, and your pain level during recovery. The study is to help surgeons develop better ways to ease the recovery of elderly patients undergoing these operations.
CONTACT: Anastacia Estocin, MPH/MSW, CRA @ (617) 732-5690 or Dr. Michael T. Jaklitsch @ (617) 732-6988

01-303 Gender Differences in the Manifestation and Treatment of Lung Cancer

FOR: Patients with suspected lung cancer.
WHY? To attempt to learn more about differences in cancer between men and women. To study differences in lung cancer symptoms and types as well as treatment options offered to cancer patients.
CONTACT: Anastacia Estocin, MPH/MSW, CRA @ (617)732-5690 or Dr. Jeanne Lukanich @ (617)732-6988

01-275 Genetic and Blood Analysis in Thoracic Diseases

FOR: Patients diagnosed with thoracic diseases.
WHY? After taking blood samples at the time of surgery and then several months later, researchers will look at the two samples to determine if there are differences between them. These samples will be used for research in lung cancer and other diseases at no cost or risk to the patient. The hope is to use these samples to identify and develop better tests screening for cancer.
CONTACT: Matt Nitz, CRC @ (617)732-6455 or Dr. Raphael Bueno @ (617)732-6703.

96-63 Molecular Markers in Human Tissues

FOR: Patients diagnosed with thoracic diseases who are undergoing surgery. WHY? To examine the changes in genetic and protein expression which occur in disease. To attempt to identify genetic markers that may predispose certain patients to various types of cancer. CONTACT: Matt Nitz, CRC @ (617)732-6455 or Dr. Raphael Bueno @ (617)732-6703.

96-100 Multimodality Therapy of Stage IIIB NSCLC Secondary to Malignant Pleural Effusion or Satellitosis

FOR: Patients with Stage IIIB NSCLC who agree to undergo induction chemotherapy followed by extrapleural pneumonectomy (surgery) with radiotherapy to follow surgery. WHY? To discover the best method of care for this stage of lung cancer, which is not currently known. To assess the effectiveness of chemotherapy(>3 cycles of Cisplatin and Taxol) followed by surgery to remove the lung, and the lining of the chest cavity (extrapleural pneumonectomy or EPP) followed by radiation treatments to the side of the removed lung. CONTACT: Mollie Baird,MPH, CRA @ (617) 732-6711, Christine Dyer, M.A., CRA @ (617) 732 5500 ext. 33858 or Dr. Michael Jaklitsch @ (617) 732-6988.

96-358 A Phase III Study of Adjuvant Chemotherapy After Resection for Patients with T2N0 Stage IB NSCLC

FOR: Patients with a diagnosis of Stage IB NSCLC whose tumors have been surgically removed. WHY? It is known that even complete surgical removal of the tumor does not guarantee that a patient will remain free of this cancer in the future. Available data show that from 30-50 % of patients whose stage I cancer has been removed will have recurrence. This study will try to determine if chemotherapy after resection will decrease that chance of recurrence. CONTACT: Dr. Arthur Skarin @ Dana Farber Cancer Institute @ (617) 632-3468.

01-229 Phase II Trial of Cisplatin, CPT - 11, Celecoxib (PCC), Concurrent Radiation Therapy and Surgery for Resectable Esophageal Cancer

FOR: Adult patients with resectable esophageal cancer. WHY? The purpose of this study is to collect information on the anti-tumor activity of the combination of 3 drugs, when given in conjunction with radiation therapy to patients with esophageal or gastroesophageal junction cancer. Researchers also want to collect information on the side effects of this drug radiation combination in these patients. Current therapy for esophageal cancer is not optimal and despite some standard treatments, many patients have recurrence. Standard therapy may cause significant side effects in many patients. Researchers are searching for more effective chemotherapy and radiation regimens that will be less toxic to patients. CONTACT: Dr. Peter Enzinger @ (617) 632-5136

02-204 Open Label Study of ALIMTA and Cisplatin in Chemonaive Patients with Malignant Pleural Mesothelioma

FOR: Chemonaive adult patients with unresectable malignant pleural mesothelioma. WHY? To evaluate the good and bad effects that ALIMTA and Cisplatin have on patients and on a patient's malignant pleural mesothelioma, and to make ALIMTA available to patients who qualify for this treatment. A previous clinical trial has suggested that the combination of ALIMTA with Cisplatin is superior to Cisplatin alone in patients with pleural mesothelioma. CONTACT: Joan Lucca, RN, MSN @ (617) 632-5403

02-199 CALGB 30102 Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Goal - Optimal Pleural Effusion Control)

FOR: Patients with malignant pleural effusions. Study patients will have a pathological diagnosis of cancer and a build-up of fluid in the chest on one side. WHY? To determine the best method to control malignant pleural effusions (MPEs), while also studying how it affects patients quality of life. To compare the effectiveness of two methods, which are randomly assigned to patients with malignant pleural effusions. CONTACT: Christine Dyer,MA,CRA @ (617)732-5500 ext 33858 or Mollie Baird,MPH,CRA @ (617)732-6711 or Dr. Jeanne Lukanich @ (617) 732-6988.

03-132 A Multicenter Phase II Trial of Neo-adjuvant ALIMTA plus Cisplatin followed by Surgery (Extrapleural Pneumonectomy) and Radiation for Pleural Mesothelioma

FOR: Patients with stage I - II malignant pleural mesothelioma, who live locally and can attend all treatments and follow-ups on location at Dana Farber Cancer Institute and Brigham and Women's Hospital. Must have adequate cardiac and lung function, and meet all eligibility criteria. WHY?To determine if this treatment will increase survival time as well as to determine the rate of response and recurrence for patients with pleural mesothelioma. CONTACT: Christine Dyer,MA,CRA @ (617)732-5500 ext 33858 or Mollie Baird,MPH,CRA @ (617)732-6711 or Dr. Jeanne Lukanich @ (617) 732-6988.

Comments to: KKee@partners.org

Division of Thoracic Surgery
Brigham and Women's Hospital
75 Francis Street
Boston, MA 02115
Phone: (617) 732-6824