Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Conditions

• Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Leucovorin — DRUG
  400 mg/m2
• Oxaliplatin — DRUG
  85 mg/m2 or 130 mg/m2 on day 1
• Fluoruracil — DRUG
  bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
• Capecitabine — DRUG
  1,000 mg/m2 twice daily for 14 days
• Radiation — RADIATION
  54 Gy (27-30 fractions)

Study Details

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Key Dates

Start date

Jun 26, 2024

Status verified

Jan 2026

Primary completion

Jan 30, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: FOLFOX OR CAPOX
  FOLFOX= Six cycles of modified FOLFOX consisting of leucovorin, oxaliplatin and bolus fluoruracil (optional), infusional fluorouracil. CAPOX= Capecitabine twice daily for 14 days and Oxaliplatin on day 1
• Active Comparator: ChemoRT
  Standard dose of infusional 5-Fluorouracil/capecitabine and radiation

Primary Outcome Measure

Clinical response rate upon re-staging [ Time Frame: 6 years ]

Central Contacts

• Chris O'Callaghan
  613-533-6430
  [email protected]

Locations (101)

Find similar trials in Phoenix, AZ

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