No Surgery Trial / Two Dose-escalation Strategies

Conditions

• Stage II Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Complete responders and Non-complete responders — PROCEDURE
  Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
• Chemoradiation + EBRT Boost — RADIATION
  45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
• Chemoradiation + HDRBT Boost — RADIATION
  45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Study Details

A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Key Dates

Start date

Apr 25, 2017

Status verified

Dec 2025

Primary completion

Jan 31, 2028

Completion

Jan 31, 2030

Study Design

Enrollment

131 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Chemoradiation + EBRT Boost
  standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders
• Experimental: Chemoradiation + HDRBT Boost
  standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions; Complete responders and Non-complete responders

Primary Outcome Measure

TME-free survival [ Time Frame: 2 years post treatment ]

Central Contacts

• Susanne Knoepfel
  5143408288
  [email protected]

Locations (1)

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