|
| RTOG L-0127 (ECOG E5597 - Coordinating Group) |
|---|
| Title: |
Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage I Non-Small Cell Lung Cancer |
| Eligibility: |
Patients who have undergone complete resection of a histologically proven stage 1A (pT1N0) or stage 1B
(pT2N0) non-small cell lung cancer (except carcinoid) who are currently free of disease. To be pathologic stage N0, at least one mediastinal lymph node must have been sampled at resection.;
NOTE: CALGB and SWOG patients must be stage T1N0 to be eligible for this study;
CALGB patients who are stage T2N0 are eligible only if they have undergone complete resection prior to June 1, 2001 and have previously refused participation in CALGB 9633 if offered.;
Eligible patients are those between 6 months and 36 months from date of surgical resection. Pathology material from the initial diagnosis must be available for review if recurrence occurs.;
Patients must not have received or be currently receiving chemotherapy or radiotherapy for lung cancer. Chest x-ray or Chest CT < 8 weeks prior to randomization must show no sign of new or recurrent lung cancer.;
Patients must be > 18 years of age.;
Patients must have normal hepatic function (total bilirubin and SGOT (AST) or SGPT (ALT), defined as less than or equal to the institutional upper limit of normal. These laboratory values must be obtained within 8 weeks prior to registration.;
Patients must have an ECOG performance status of 0-1.;
Patients not taking mineral, herbal, phytochemical, or vitamin supplements at the time of entry must agree to not begin taking such supplements (except for the study designated tablet) during the course of participation. Patients taking any supplement(s) prior to study entry must agree to one of the following in order to be eligible:
NOTE: Supplements are defined as any non-food compound taken by mouth or injection which are intended to provide dietary factors.;
Patients who have been regularly (at least 3 times per week for more than 4 consecutive weeks during the year prior to consideration for the trial) taking a supplement containing selenium are not eligible if the supplement contains > 50 µg selenium.;
Patiens who have been regularly (at least 3 times per week for more than 4 consecutive weeks during the year prior to consideration for the trial) taking a supplement that contains < 50 µg selenium are eligible, provided (s)he agrees to continue taking the same supplement on the same schedule for the entire duration of study participation.;
If the supplement does NOT contain selenium, the patient must discontinue supplement(s) for at least two weeks prior to study entry and agree to remain off supplement(s) for the duration of study participation; OR agree to continue taking the same supplement(s), on the same schedule for the entire duration of study participation.;
Any supplement(s) containing > 50 µg of selenium are absolutely disallowed in this study.;
No concurrent cancers or any prior cancer history within the past 5 years except localized non-melanoma skin cancer.;
No synchronous lesions (lung + non-lung) or metastasis, even if resectable. No history of greater than one lung cancer primary at any time.;
Patients must be free of disease.;
Patients must have consumed at least 75% of tablets during 4 week run-in period. |
| TX: | Selenium yeast vs. placebo yeast. |
| Sample Size: | 1750 |
| 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 must be considered unresectable or inoperable; 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
|
| Sample Size: | 500 |
| RTOG 0618 |
|---|
| Title: |
A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer |
| Eligibility: |
Histological confirmation of NSCLC is required by either biopsy or cytology within 60 days prior to registration. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise specified. Although bronchioloalveolar cell carcinoma is a subtype of NSCLC, patients with the pure type of this malignancy are excluded from this protocol because this cancer's spread between adjacent airways is difficult to target on CT. Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC Lung 6th Edition, 2002 stage I or II based on only one of the following combinations of TNM staging:
- T1, N0, M0
- T2 ( 5 cm), N0, M0
- T3 ( 5 cm), N0, M0 chest wall primary tumors only
The patient must be considered a reasonable candidate for surgical resection of the primary tumor according to the following criteria:
- A qualified thoracic surgeon should make the determination prior to registration that there would be a high likelihood of negative surgical margins.
- baseline FEV1 > 35% predicted,
- postoperative predicted FEV1 > 30% predicted,
- diffusion capacity > 35% predicted,
- absent baseline hypoxemia and/or hypercapnia,
- exercise oxygen consumption > 50% predicted,
- absent severe pulmonary hypertension,
- absent severe cerebral, cardiac, or peripheral vascular disease,
- absent severe chronic heart disease.
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; Age > 18 years; Zubrod performance status 0-1within 45 days prior to study entry; Women of childbearing potential and male participants must use an effective contraceptive method, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills. CBC/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) > 1,800 cells/mm3, Platelets > 100,000 cells/mm3, Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.) Patient must provide study-specific consent prior to study entry.
|
| Treatment |
Stereotactic Body Radiation Therapy (SBRT),
20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
|
| Sample Size: | 33 |
| 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 1 week 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 |
|
|
|
|
