Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

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.

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

Surgery

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.

Chest Irradiation

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

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.

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.

Prophylactic Cranial Irradiation

Ritsuko Komaki, MD

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.

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.

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

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

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.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Syndrome

Pancoast Syndrome

Anti-Infective Agents

Mitomycins

Mitomycin

Vindesine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

mitomycin C, vindesine, cisplatin and radiotherapy

Harubumi Kato, M.D., Ph.D.

The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.

Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.

Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)

A Phase II Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors: Initial Report of Japan Clinical Oncology Group Trial (JCOG 9806)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors	NCT00984997	Lung Cancer	Surgery Chest Irradiati... Cisplatin Etoposide Prophylactic Cr...	18 Years - 70 Years	M.D. Anderson Cancer Center
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)	NCT00128037	Pulmonary Neopl...	mitomycin C, vi...	15 Years - 74 Years	Japan Clinical Oncology Group
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors	NCT00984997	Lung Cancer	Surgery Chest Irradiati... Cisplatin Etoposide Prophylactic Cr...	18 Years - 70 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for superior sulcus tumor