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Summaries - Lung
Lung Cancer Protocols
RTOG 0617
Title: A Randomized Phase III Comparison of Standard- Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer
Eligibility: Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy; patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor also are eligible. Patients must be considered unresectable or inoperable; Note: Patients who have had a nodal recurrence after surgery for an early-stage NSCLC are eligible if the following criteria are met:

  • Nodal recurrence must be N1 or N2; N3 is not eligible.
  • The initial primary must have been staged as T1-2, N0, M0.
  • The node must be biopsied within 12 weeks of registration.
  • The node must be measurable.
  • The patient must not have received prior chemotherapy or radiation for this lung cancer.
  • Prior curative surgery must have been at least 6 months prior to the nodal recurrence.
  • The exception to a prior invasive malignancy (Section 3.2.7) does not apply to the initial lung primary.
Stage III A or B disease, including no distant metastases; Patients must have measurable or evaluable disease; Patients with post-obstructive pneumonia are eligible; Patients must be at least 3 weeks from prior thoracotomy (if performed); Zubrod Performance Status 0-1; Age > 18; The best FEV1value obtained pre- or post bronchodilator must be > 1.2 liters/second or > 50% predicted; Adequate bone marrow function as defined in the protocol; Serum creatinine within normal institutional limits or creatinine clearance >60 ml/min; Bilirubin within normal institutional limits; AST and ALT < 2.5 x the IULN; Patient must sign study specific informed consent prior to study entry.
Standard Dose (60 Gy) versus High Dose (74 Gy) RT With Concurrent and Consolidation Chemotherapy +/-Cetuximab

 Arm A:
Concurrent Carboplatin/Paclitaxel, Weekly x 7
RT to 60 Gy, 5 x per week for 6 weeks
Consolidation Carboplatin/Paclitaxel, Q 3 weeks x 2 cycles

Arm B:
Concurrent Carboplatin/Paclitaxel, Weekly x 7
RT to 74 Gy, 5 x per week for 7.5 weeks
Consolidation Carboplatin/Paclitaxel, Q 3 weeks x 2 cycles

Arm C
Cetuximab Loading Dose: Week 1, Day 1
then Concurrent chemotherapy, Carboplatin & Paclitaxel, and Cetuximab
RT to 60 Gy, 5 x per week for 6 weeks
Consolidation Carboplatin/Paclitaxel, Q 3 weeks x 2 cycles + Cetuximab

Arm D
Cetuximab Loading Dose: Week 1, Day 1
then Concurrent chemotherapy, Carboplatin & Paclitaxel, and Cetuximab:
RT to 74 Gy, 5 x per week for 7.5 weeks
Consolidation Carboplatin/Paclitaxel, Q 3 weeks x 2 cycles + Cetuximab

Study size: 500

 

RTOG 0813
Title: Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients
Eligibility: Pathologically proven diagnosis of non-small cell lung cancer (NSCLC); Stage T1-2, N0, M0, tumor size < 5 cm; the primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins, defined as a potentially curative resection (PCR). However, the patient must have underlying physiological medical problems that would prohibit a PCR and be deemed "medically inoperable" with a tumor within or touching the zone of the proximal bronchial tree. Patients must have measurable disease. Zubrod Performance Status 0-2; Age > 18; Pleural effusion, if present, must be deemed too small to tap under CT guidance and must not be evident on chest x-ray. Pleural effusion that appears on chest x-ray will be permitted only after thoracotomy or other invasive procedure(s). Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential; Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment); Patients must provide study-specific informed consent prior to any protocol specified procedures. No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years; previous lung cancer, if the patient is disease-free for a minimum of 2 years is permitted. No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; no prior chemotherapy for the study cancer; no plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression; no plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression.
SBRT Escalating dose levels; protocol treatment begins at Level 5, 10 Gy; at all levels, patients will receive q 2 day fractionation X 5 fractions over 1.5-2 weeks
Sample Size: 94

 

RTOG 0915
Title: A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients with Stage I Peripheral Non-Small Cell Lung Cancer
Eligibility: Histological confirmation (by biopsy or cytology) of non-small cell lung cancer (NSCLC) prior to treatment; the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine, or non-small cell carcinoma not otherwise specified; Note: although bronchioloalveolar cell carcinoma is a subtype of NSCLC, patients with the pure type of this malignancy are excluded from this study because the spread of this cancer between adjacent airways is difficult to target on CT. Stage T1, N0, M0 or T2 (< 5 cm), N0, M0; Patients with hilar or mediastinal lymph nodes < 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. The patient's resectable NSCLC must be considered medically inoperable by an experienced thoracic cancer clinician (a thoracic surgeon, medical oncologist, radiation oncologist, or pulmonologist) or a standard lobectomy and mediastinal lymph node dissection/sampling procedure. The patient may have underlying physiological medical problems that would prohibit a surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functioning lung. These types of patients with severe underlying health problems are deemed "medically inoperable." Standard justification for deeming a patient medically inoperable based on pulmonary function for surgical resection of NSCLC may include any of the following:
  • Baseline FEV1 < 40% predicted;
  • Postoperative FEV1 < 30% predicted;
  • Severely reduced diffusion capacity;
  • Baseline hypoxemia and/or hypercapnia;
  • Exercise oxygen consumption < 50% predicted;
  • Severe pulmonary hypertension;
  • Diabetes mellitus with severe end organ damage;
  • Severe cerebral, cardiac, or peripheral vascular disease;
  • Severe chronic heart disease.
The patient must have measurable disease. Zubrod Performance Status 0-2; Age > 18; Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential; Women of childbearing potential and male participants must agree to use a medically effective means of birth control, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills, throughout their participation in the treatment phase of the study. The patient must provide study specific informed consent prior to study entry.
SBRT Stereotactic Body Radiation Therapy
Arm 1: 34 Gy in 1 fraction
Arm 2: 48 Gy in 4 once-daily consecutive fractions
Sample Size: 88

 

RTOG 0937
Title: Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Eligibility: Pathologically (histologically or cytologically) proven diagnosis of extensive disease small cell lung cancer without brain metastases and with 1-3 metastatic lesions within 6 months of registration; Note: This does NOT include patients initially diagnosed with LD-SCLC who have progressed. Patients must have completed 4-6 cycles of platinum-based chemotherapy. Patients must be registered on study within 8 weeks of completing chemotherapy. Prior to chemotherapy (at diagnosis), patients must have extensive stage disease with 1-3 extracranial metastatic lesions (no brain metastases). For example, the patient could have 2 lesions in the liver and 1 in the contralateral lung; or 1 in the bone, 1 in the contralateral lung, and 1 in the liver; or 3 liver lesions, etc. Lesion is not defined as "organ". After chemotherapy, patients will be restaged using the same minimal diagnostic work up as required pre-chemotherapy and patients must have:
  • no CNS metastases;
  • radiographic partial or complete response to chemotherapy in a minimum of 1 site of disease using RECIST criteria (see Section 11.3.2); Note: if radiation has been delivered to primary disease with chemotherapy, there must be complete or partial response in at least 1 of the sites that has not been treated with radiation.
  • no progression in any site;
  • for the purposes of stratification, a response to treatment is only considered a "CR" if the patient has had a complete response in all sites of measurable disease.
Patients who have had thoracic radiation concurrently or prior to chemotherapy for the current diagnosis and meet all other eligibility criteria are eligible for the study but will not receive mediastinal radiation per protocol. Measurements for all post-chemotherapy measurable disease must be submitted. Zubrod Performance Status 0-2; Age > 18; For patients who will be treated with radiation to the liver, adequate hepatic function as defined in the protocol; For patients who will be treated with radiation to the kidneys, adequate renal function as defined in the protocol. All patients must have adequate bone marrow function as defined in the protocol. For women of childbearing potential, a negative serum pregnancy test within 1 week of registration; All toxicities related to chemotherapy must be resolved to < grade 1 prior to initiation of study therapy (with the exception of neuropathy and alopecia, which may take a longer period to recover). Laboratory abnormalities, with the exception of those specified in Sections 3.1.9, 3.1.10, and 3.1.11, are allowed if they are not deemed clinically significant. Patients must provide study-specific informed consent prior to study entry.
PCI vs. PCI +
Consolidative RT		 Arm 1: Prophylactic Cranial Irradiation
2.5 Gy per fraction for a total of 25 Gy

Arm 2: Prophylactic Cranial Irradiation
2.5 Gy per fraction for a total of 25 Gy
and
Consolidative Radiation to
Locoregional and Residual Metastatic Disease
45 Gy at 3 Gy per fraction*

*Acceptable alternative: 40 Gy at 4 Gy per fraction
Sample Size: 154