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A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Record Grade 3 or higher rate of non-hematologic, acute treatment-related toxicities

Outcome Time Frame:

Six months after end of radiation therapy

Safety Issue:

Yes

Principal Investigator

Bradford S Hoppe, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0802-LU02

NCT ID:

NCT00881712

Start Date:

June 2009

Completion Date:

April 2035

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung Cancer
  • Proton Radiation
  • Stage III
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Florida Proton Therapy Institute Jacksonville, Florida  32206