Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)

University of Florida

Status: Terminated

Conditions: Non-Small Cell Lung Cancer

Treatments: Radiation: PET positive nodal disease measuring less than 15 mm; Radiation: PET positive nodal disease measuring 15 mm or greater; Radiation: Patients considered resectable

Study type: Interventional

Funder types: Other

Identifiers

NCT00881712

UFPTI 0802-LU02

Details and patient eligibility

About

The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
• Patient must be at least 18 years old at the time of consent.
• Stage III A or III B disease.
• Patients must be able to start study treatment within 6 weeks of study enrollment.
• Induction chemotherapy is allowed.
• Marginally resectable or unresectable at presentation.
• If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.

Exclusion criteria

• Evidence of distant metastasis.
• Prior thoracic radiotherapy.
• Any history of allergic reaction to taxanes.
• Prior tumor resection. Candidate for upfront curative surgery.
• Pleural effusion visible on chest x-ray or the scout view of the CT chest.
• Unintentional weight loss within the month prior to diagnosis ≥ 10%.
• Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
• The presence of PET positive contralateral hilar disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

PET positive nodal disease measuring 15 mm or greater

Experimental group

Description:

Proton radiation with concomitant chemotherapy

Treatment:

Radiation: PET positive nodal disease measuring 15 mm or greater

PET positive nodal disease measuring less than 15 mm

Experimental group

Description:

Proton radiation

Treatment:

Radiation: PET positive nodal disease measuring less than 15 mm

Patients considered resectable

Experimental group

Description:

Proton radiation plus surgery

Treatment:

Radiation: Patients considered resectable