Trinity Medical Center Cancer Treatment
Protocols
BREAST
BREAST – ADJUVANT
Protocol
Description
NSABP B-43
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with
Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive
Ductal Carcinoma in Situ Resected by Lumpectomy
S1007
A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive
and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
S1207
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of
Adjuvant Endocrine Therapy +/- One Year Everolimus in Patients with High-Risk,
Hormone Receptor-Positive and HER2/neu Negative Breast Cancer
BREAST – ADVANCED
Protocol
E2108
Description
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact
Primary Tumor in Patients with Metastatic Breast Cancer
GASTROINTESTINAL (GI)
GI – ADJUVANT COLORECTAL
Protocol
CALGB 80702
Description
A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or
Placebo for Patients with Resected Stage III Colon Cancer
GI – ADVANCED COLORECTAL
Protocol
E7208
Description
A Randomized Phase II Study of Irinotecan and Cetuximab with or without the
Anti-Angiogenic Antibody, Ramucirumab, in Advanced, K-ras Wild-type Colorectal
Cancer following Progression on Bevacizumab-Containing Chemotherapy
***TEMPORARILY SUSPENDED, 6/14/12***
N1048
A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined
Modality Chemoradiation vs Preoperative Combined Modality Chemoradiation for
Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection
with Total Mesorectal Excision
OTHER GI
Protocol
CALGB 80803
Description
Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in
Esophageal Cancer
***PENDING***
E2211
A Randomized Phase II Study of Temozolomide or Temozolomide and
Capecitabine in Patients with Advanced Neuroendocrine Tumors
RTOG 1010
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment
of HER2-Overexpressing Esophageal Adenocarcinoma
***PENDING***
S1201
A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for
Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for
Advanced / Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ)
Cancer
GENITO-URINARY (GU)
Protocol
Description
A031203
Randomized Phase II Study Comparing Cabozantinib with Commercially-Supplied
Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic
Renal Cell Carcinoma
RTOG 0534
A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or
Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a
Rising PSA After Radical Prostatectomy
S1216
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK700 with Androgen Deprivation Therapy + Bicalutamide in Patients with NewlyDiagnosed Metastatic Hormone-Sensitive Prostate Cancer
GYNECOLOGIC
Protocol
GOG 0238
Description
A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly
Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine
Corpus
HEAD AND NECK
Protocol
Description
E1305
A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in
Patients with Recurrent or Metastatic Head and Neck Cancer
E1311
A Randomized, Placebo-Controlled Phase II Trial of Afatinib as Adjuvant Therapy
Following Chemoradiation in Patients with Head and Neck Squamous Cell
Carcinoma at High Risk of Recurrence
HEMATOLOGIC
Protocol
E1412
Description
Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs
RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone)
in Patients with Newly-Diagnosed Diffuse Large B Cell Lymphoma
***PENDING***
E1A11
Randomized Phase II Trial of Bortezomib, Lenalidomide and Dexamethasone
(VRd) vs Carfilzomib, Lenalidomide and Dexamethasone (CRd) followed by
Limited or Indefinite Duration Lenalidomide Maintenance in Patients with NewlyDiagnosed Symptomatic Multiple Myeloma
***PENDING***
S1117
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide vs
Azacitidine Alone vs Azacitidine in Combination with Vorinostat for Higher-Risk
Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CLL)
***TEMPORARILY CLOSED, 4/15/14***
S1211
A Randomized Phase I/II Study of Optimal Induction
***PENDING***
LUNG
SMALL CELL LUNG
Protocol
CALGB 30610
E2511
Description
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with
Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
Phase I and Randomized Phase II Double-Blind Clinical Trial of Cisplatin and
Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline
Therapy for Extensive Stage Small Cell Lung Cancer
***PHASE II PENDING***
NON-SMALL CELL LUNG
Protocol
E6508
S0819
Description
A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and
IIIB Non-Squamous Non-Small Cell Lung Cancer after Definitive Chemoradiation
A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin /
Paclitaxel / Bevacizumab with or without Concurrent Cetuximab in Patients with
Advanced Non-Small Cell Lung Cancer
***TEMPORARILY CLOSED, 6/1/14***
MELANOMA
Protocol
Description
A091201
Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to
Temozolomide / Dacarbazine in Ocular Melanoma
E1609
A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy vs
High-Dose Interferon Alfa-2b for Resected High-risk Melanoma
E2607
Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or
Stage IV Mucosal, Acral and Solar Melanomas
E3611
A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in
Combination with High Dose Interferon-α in Advanced Melanoma
E3612
A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in
Patients with Unresectable Stage III or Stage IV Melanoma
SARCOMA
Protocol
A091102
Description
Phase II Study of MLN8237 in Advanced / Metastatic Sarcoma
SYMPTOMS CONTROL
Protocol
Description
A221101
The Use of Armodafinil (Nuvigil®) to Reduce Cancer-Related Fatigue in Patients
with Glioblastoma Multiforme: A Randomized, Novel Adaptive Design Study
A221102
Randomized Double-Blind Placebo-Controlled Study of Subcutaneous
Testosterone in the Adjuvant Treatment of Postmenopausal Women with
Aromatase Inhibitor-Induced Arthralgias