Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC

NCT02619448 | Recruiting Early Phase 1

• 1 other identifier: 665895
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment for patients with Non-Small Cell Lung Cancer (NSCLC) and clinically negative lymph nodes remains surgery per current guidelines. Five year survival for patients with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of these patients have heart and lung issues or other diseases which keep them from undergoing curative surgery. Studies have shown that majority of these patients die from their cancer and not from their other diseases. This is the reason for treating early stage lung cancer patients with definitive therapy, when they cannot have surgery. This study will enroll twelve subjects to evaluate the side effects of this treatment, and decide if it is a good option for the patients that cannot have surgery.

Conditions

Non-small Cell Lung Cancer

Keywords

inoperable; Solitary [T1bN0, T2aN0, T2bN0] lesion measuring 2-7 cm

Outcome Measures

Primary Outcomes (1)

• Toxicity as measured using the National Cancer Institute's Common Terminology Criteria for Adverse Events

  Specifically grade 3+ toxicity associated with the treatment will be summarized by grade and type.

  24 months

Secondary Outcomes (6)

• Radiographic response as measured by PET/CT

  24 months

• Local progression as measured by PET/CT

  24 months

• Regional progression as measured by PET/CT

  24 months

• Distant progression as measured by PET/CT

  24 months

• Time to overall progressions as measured by PET/CT

  24 months

Study Arms (1)

Chemotherapy with hypofractionated RT

EXPERIMENTAL

Carboplatin AUC 2 + Paclitaxel 50 mg/m2 given weekly x 4 concurrently with radiation therapy (70 Gy in 20 fractions) over 4 weeks

Drug: Carboplatin; Drug: Paclitaxel; Radiation: 70 Gy in 20 fractions over 4 weeks

Interventions

Carboplatin DRUG

chemotherapy

Also known as: Paraplatin

Chemotherapy with hypofractionated RT

Paclitaxel DRUG

chemotherapy

Also known as: taxol

Chemotherapy with hypofractionated RT

70 Gy in 20 fractions over 4 weeks RADIATION

accelerated hypofractionated RT

Chemotherapy with hypofractionated RT

Eligibility Criteria

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

You may qualify if:

• Pathologically or cytologically proven diagnosis of non-small cell lung carcinoma.
• Solitary \[T1bN0M0, T2aN0M0, T2bN0M0\] lesion measuring 2-7cm in size. Staging is per AJCC 7th edition of TNM classification.
• Patient must meet criteria for receipt of hypofractionated radiation therapy
• Medically inoperable pulmonary status, cardiac status, or other serious co-morbidity, or patient refusal of primary surgery for lung cancer.
• ECOG Performance status of 0-2.
• Patients may have prior treatment for lung cancer based on the following criteria:
• Surgical resection is allowed if surgery was \> 12 months ago.
• Patients treated with prior radiation are eligible if radiation was \> 12 months ago and there is no evidence of progression and if the lesion is in a different lobe.
• Prior chemotherapy if \> 18 months ago

You may not qualify if:

• Node positive or metastatic disease.
• Other active malignancy (specifically, risk of recurrence in 3 years estimated to be greater than 50%) except for non-melanoma skin cancer, in-situ cervical carcinoma (CIN), or low-risk prostate carcinoma on active surveillance are to be excluded.
• Inability to receive systemic therapy or radiation therapy per protocol.
• Inability to fulfill requirements of the protocol.
• Any co-morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Michael Mix, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Bingham, BS

CONTACT

3154643603; binghame@upstate.edu

Sherice Simpson, MS

CONTACT

3154645934; simpsons@upstate.edu

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: March 16, 2015
• First Posted: December 2, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

US (1)