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PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery · Source last updated 2024-02-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. \> \> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.\> \> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.\> \> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.

   id

   FG000

   title

   Group 1

2. description

   Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.\> \> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.\> \> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.\> \> surgery: low anterior resection with total mesorectal excision

   id

   FG001

   title

   Group 2

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         597

      2. group Id

         FG001

         num Subjects

         597

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         585

      2. group Id

         FG001

         num Subjects

         543

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         54

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice