Study: NCT00070434

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine
Description: 825mg/m2 BID, PO, daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine
Description: 825mg/m2 BID, PO, daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine
Description: 825mg/m2 BID, PO, daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fluorouracil
Description: Bolus + IV for 46 hrs on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fluorouracil
Description: Bolus + IV for 46 hrs on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: irinotecan hydrochloride
Description: IV infusion over 90 min on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: irinotecan hydrochloride
Description: IV infusion over 90 min on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: 200mg/m2 IV 2 hour infusion on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: 200mg/m2 IV 2 hour infusion on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxaliplatin
Description: 85mg/m2 IV infusion for 90minutes on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxaliplatin
Description: 85mg/m2 IV infusion for 90minutes on Day 1

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyridoxine
Description: 50mg TID, PO daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyridoxine
Description: 50mg TID, PO daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyridoxine
Description: 50mg TID, PO daily