Adult Clinical Trials:GASTROINTESTINAL

RTOG 0436 Gastrointestinal

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated without Surgery

• 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.
• 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 systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable.
• No prior chest radiotherapy.
• No severe, active comorbidity as defined in the protocol.

Treatment
Arm 1: Radiation Therapy + Paclitaxel + Cisplatin + Cetuximab
Arm 2: Radiation Therapy + Paclitaxel + Cisplatin

RTOG 0822: Gastrointestinal

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
By Order of the Diploma
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

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