Summaries - Gastrointestinal Gastrointestinal Cancer Protocols RTOG 0436 Number: RTOG 0436 Title: A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated without Surgery Eligibility: Histologically proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 6 weeks prior to registration. Patients with involvement of the gastroesophageal junction with Siewert type I or II tumors (tumors arising from the distal esophagus and involving the esophagogastric junction or tumors starting at the esophagogastric junction and involving the cardia) are eligible; Disease must be encompassed in a radiotherapy field; Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible; Patients with cervical esophageal carcinoma are eligible; Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a; Zubrod performance status 0-2; Age > 18; Adequate bone marrow function as specified in the protocol; Patient's total intake (oral/enteral) must be > 1500 kCal/day; Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula; No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years; No prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable; No prior chest radiotherapy; No prior therapy that specifically and directly targets the EGFR pathway; No prior platinum-based and/or paclitaxel-based therapy. No prior allergic reaction to the study drugs involved in this protocol; No prior severe infusion reaction to a monoclonal antibody; No severe, active comorbidity as defined in the protocol; Pregnant or nursing women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception are excluded; Patients must provide study-specific informed consent prior to study entry. Radiochemotherapy +/- cetuximab: Arm 1: Radiation Therapy + Paclitaxel + Cisplatin + Cetuximab Arm 2: Radiation Therapy + Paclitaxel + Cisplati Study size: 420 RTOG 0438 Number: RTOG 0438 Title: A Phase I Trial of Highly Conformal Radiation Therapy for Patients with Liver Metastases Eligibility: Non-lymphoma liver metastases confirmed pathologically or new radiographic liver lesions most consistent with metastases in a patient with known pathologically proven non-lymphoma cancer and a previously negative contrast CT, MRI or PET/CT of the liver. < 5 liver lesions measurable on a contrast-enhanced liver CT, MRI or PET/CT performed within 6 weeks prior to study entry; liver metastases measuring < 8 cm. All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria. Patient is medically unfit for surgery or patient is deemed surgically unresectable. Zubrod Performance Scale = 0-1. Age > 18. Adequate bone marrow function, defined as follows: Absolute neutrophil count (ANC) > 1,800 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study; Platelets > 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study; Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.) Previous liver resection or ablative therapy is permitted. Chemotherapy and/or targeted agent therapy must be completed at least 2 weeks prior to radiation. Women of childbearing potential and male participants must practice adequate contraception. Patient must sign study specific informed consent prior to study entry. Pretreatment Evaluations Required for Eligibility include: A complete history and general physical examination. For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to registration. INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 2 weeks prior to study entry participants must practice adequate contraception. Patient must sign study specific informed consent prior to study entry. Pretreatment Evaluations Required for Eligibility include: A complete history and general physical examination. For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to registration. INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 2 weeks prior to study entry (Treatment) All Patients will receive 10 fractions Monday-Friday for 2 weeks at the following levels; Dose escalation by 0.5 Gy to maximum of 50 Gy, as follows: Dose level Level I †Level II Level III Level IV Dose per fraction 3.5 Gy 4.0 Gy 4.5 Gy 5.0 Gy Total dose 35 Gy 40 Gy 45 Gy 50 Gy †Protocol Treatment Begins at Level II Study size: 18 RTOG 0822 Number: RTOG 0822 Title: A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer Eligibility: Pathologically proven diagnosis of adenocarcinoma of the rectum (located up to 12 cm from the anal verge on flexible endoscopy) within 56 days of registration; Diagnosis of rectal adenocarcinoma must be obtained by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy); Clinically determined to be stage T3 or T4,N0-N2, and M0, based upon the following minimum diagnostic workup: Colonoscopy within 56 days prior to registration History/physical examination (including medication history screen for contraindications) within 56 days prior to registration Contrast-enhanced imaging of the abdomen and pelvis either by CT, MRI, or PET-CT (whole body) within 56 days prior to registration. (NOTE: whole body PET-CT preferred) Chest x-ray (or CT) of the chest within 56 days prior to registration to exclude distant metastases (except for those who have had whole body PET-CT) Transrectal ultrasound (TRUS) within 56 days prior to registration is required to establish T stage, unless clinical exam, CT of the pelvis, and/or MRI demonstrates T4 lesion; in these cases TRUS is not required. Zubrod Performance Status 0-2; Age > 18; CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) > 1800 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.). Metabolic panel within 28 days prior to registration on study, with adequate liver and renal function defined as follows: AST and alkaline phosphatase < 2.5 x upper limit of normal (ULN) Bilirubin < 1.5 ULN Calculated creatinine clearance (CrCl) > 50 ml/min using Cockcroft-Gault formula as below: CrCl male = (140 - age) x (wt. in kg) / (Serum Cr) x 72 CrCl female = 0.85 x (CrCl male) Serum pregnancy test within 14 days prior to registration on study (for female patients of childbearing potential); Patient must provide study-specific informed consent prior to study entry. (Treatment) Radiation Therapy Pelvic IMRT: 45 Gy in 25 fx 3DCRT boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx PLUS Concurrent Preoperative Chemotherapy Capecitabine, Oxaliplatin ↓ (4-8 wks) Surgery ↓(4-8 wks) Postoperative Chemotherapy FOLFOX Study size: 75