Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma
Brief Summary: Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC).

Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.

Test products:

Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1 (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line: oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity.

Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any other moment when progression is suspected. After cessation of chemotherapy, patients will be followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria.


Options:
A: Arm Label: Regorafenib (Stivarga, BAY73-4506)+BSC; Type: EXPERIMENTAL; Interventions: Drug: Regorafenib (Stivarga, BAY73-4506), Other: Best Supportive Care (BSC) | Arm Label: Placebo+BSC; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Other: Best Supportive Care (BSC) | Intervention Type: DRUG; Name: Regorafenib (Stivarga, BAY73-4506); Assigned to Arm(s): Regorafenib (Stivarga, BAY73-4506)+BSC | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo+BSC | Intervention Type: OTHER; Name: Best Supportive Care (BSC); Assigned to Arm(s): Placebo+BSC, Regorafenib (Stivarga, BAY73-4506)+BSC
B: Arm Label: Arm I; Type: ACTIVE_COMPARATOR; Interventions: Drug: fluorouracil, Drug: irinotecan hydrochloride, Drug: leucovorin calcium, Drug: oxaliplatin | Arm Label: Arm II; Type: EXPERIMENTAL; Interventions: Biological: bevacizumab, Drug: fluorouracil, Drug: irinotecan hydrochloride, Drug: leucovorin calcium, Drug: oxaliplatin | Intervention Type: BIOLOGICAL; Name: bevacizumab; Assigned to Arm(s): Arm II | Intervention Type: DRUG; Name: fluorouracil; Assigned to Arm(s): Arm I, Arm II | Intervention Type: DRUG; Name: irinotecan hydrochloride; Assigned to Arm(s): Arm I, Arm II | Intervention Type: DRUG; Name: leucovorin calcium; Assigned to Arm(s): Arm I, Arm II | Intervention Type: DRUG; Name: oxaliplatin; Assigned to Arm(s): Arm I, Arm II
C: Arm Label: 1Capecitabine-irinotecan; Type: ACTIVE_COMPARATOR; Interventions: Drug: capecitabine-irinotecan | Arm Label: 2capecitabine plus irinotecan; Type: EXPERIMENTAL; Interventions: Drug: capecitabine+irinotecan (1st line) | Intervention Type: DRUG; Name: capecitabine-irinotecan; Assigned to Arm(s): 1Capecitabine-irinotecan | Intervention Type: DRUG; Name: capecitabine+irinotecan (1st line); Assigned to Arm(s): 2capecitabine plus irinotecan
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: CPT-11 and TS-1 | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: CPT-11, 5-FU and l-LV | Intervention Type: DRUG; Name: CPT-11 and TS-1; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: CPT-11, 5-FU and l-LV; Assigned to Arm(s): 2

Answer: C