Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

NCT01781741 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: I 223812NCI-2013-00055
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies stereotactic body radiation therapy after surgery in treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after lymphadenectomy may kill any tumor cells that remain after surgery.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4

  Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.

  Up to 3 years

Secondary Outcomes (4)

• Time until chemotherapy

  From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years

• Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens

  Up to 5 years

• Overall survival

  From SBRT completion until death, assessed up to 5 years

• Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module

  Up to 5 years

Study Arms (1)

Treatment (TEMLA and SBRT)

EXPERIMENTAL

Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery.

Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT); Other: quality-of-life assessment

Interventions

therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT) COMBINATION_PRODUCT

Undergo TEMLA and SBRT

Treatment (TEMLA and SBRT)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Treatment (TEMLA and SBRT)

Eligibility Criteria

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

You may qualify if:

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Have histologically proven diagnosis of non-small cell lung cancer (NSCLC) (stage III and stage IV \[to include limited volume metastases such as brain, bone, adrenal\])
• Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving and study related procedure
• Patients with chemotherapy prior to TEMLA are eligible

You may not qualify if:

• Contraindication to SBRT or TEMLA; this includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly
• If patient has an open thoracotomy for lung cancer they will not be able to receive SBRT and will be replaced
• Pregnant or nursing female patients
• Unwilling or unable to follow protocol requirements
• Any condition which the investigator's opinion deems the patient ineligible
• Received an investigational agent within 30 days prior to enrollment

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (1)

• Singh AK, Hennon M, Ma SJ, Demmy TL, Picone A, Dexter EU, Nwogu C, Attwood K, Tan W, Hermann GM, Fung-Kee-Fung S, Malhotra HK, Yendamuri S, Gomez-Suescun JA. A pilot study of stereotactic body radiation therapy (SBRT) after surgery for stage III non-small cell lung cancer. BMC Cancer. 2018 Nov 29;18(1):1183. doi: 10.1186/s12885-018-5039-5.

  PMID: 30497431 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anurag Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: March 6, 2013
• Primary Completion: November 30, 2015
• Study Completion: October 14, 2020
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

US (1)