Radiation Oncology/RTOG Trials/0117

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RTOG 01-17 (NSCLC)

RTOG Lung Trials
  • Title: A Phase I/II Dose Intensification Study using Three Dimensional Conformal Radiation Therapy and Concurrent Chemotherapy for Patients with Inoperable, Non-Small Cell Lung Cancer
  • Objective:
    • 1) For the Phase I portion of the study, the primary objective is to establish the maximum tolerated dose (MTD) of radiotherapy, in terms of Gy per fraction, that can be delivered using three-dimensional conformal radiation treatment (3D-CRT) concurrently with Taxol and carboplatin chemotherapy.
    • 2) For the Phase II portion of the study, the primary objective is to estimate the percentage of patients that survive at least 12 months.
  • Protocol:
    • Concurrent weekly paclitaxel (50 mg/m2) and carboplatin (AUC 2) x 7 weeks
Dose level Original Protocol Amended Protocol Cohort
1 75.25 / 35 fx
2.15 Gy per fx
1
2 80.5 Gy / 35 fx
2.3 Gy per fx
(Amended, since Dose Level 1 was too toxic)
74 Gy / 37 fx
2.0 Gy per fx
(de-escalation dose)
2 (MTD)
3 79.5 Gy / 30 fx
2.65 Gy per fx
(Amended, since Dose Level 1 was too toxic)
70 Gy / 35 fx
2.0 Gy per fx
(de-escalation dose)
Not necessary since Dose Level 2 was safe
4 75 Gy / 25 fx
3.0 Gy per fx
(Amended, since Dose Level 1 was too toxic)
N/A
  • Eligibility:
    • NSCLC Stages I-IIIB
    • Total lung V20 must be ≤ 30%, mean esophageal dose ≤ 34 Gy, esophageal V55 ≤ 30 Gy
  • Treatment Details:
    • No elective nodal irradiation
    • Prescription dose at ICRU reference point. The 93% isodose line must cover the entire PTV.
    • Dose calculated without heterogeneity corrections
  • Enrollment Target: 73 patients maximum
  • Activation: July 13, 2001
  • Closed: November 27, 2007
  • Conclusion:
    • Phase I: 2010 PMID 20457350 A phase I/II radiation dose escalation study with concurrent chemotherapy for patients with inoperable stages I to III non-small-cell lung cancer: phase I results of RTOG 0117. (Bradley JD, Int J Radiat Oncol Biol Phys. 2010) Conclusion: The maximum tolerated dose was determined to be 74 Gy/37 fractions (2.0 Gy per fraction) using three-dimensional conformal radiation therapy with concurrent paclitaxel and carboplatin therapy. This dose level in the Phase II portion has been well tolerated, with low rates of acute and late lung toxicities.
  • Publications:
    • 2010 PMID 20368547 Primary analysis of the phase II component of a phase I/II dose intensification study using three-dimensional conformal radiation therapy and concurrent chemotherapy for patients with inoperable non-small-cell lung cancer: RTOG 0117. (Bradley JD, J Clin Oncol. 2010) Conclusion: The median survival time and OS rate at 12 months for this regimen are encouraging. These results serve as projection expectations for the high-dose radiation arms of the current RTOG 0617 phase III intergroup trial.