Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial

Part of paid clinical trials in St Louis, Missouri.

Sponsor
University Medical Center Groningen
Study ID
NCT01558921
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M1 scheme — OTHER
    short course 5x5Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX
  • standard long course chemoradiotherapy — OTHER
    long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.

Study Details

Currently the 3-year disease free survival of patients with locally advanced rectal cancer is about 50%. Current standard treatment for patients at high risk of failing locally and/or systemically includes pre-operative long course radiotherapy (5 weeks) in combination with chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has been demonstrated to improve local control, but had no effect on the overall survival. Different studies in patients with rectal cancer studying the effect of adjuvant post operative chemotherapy did not result in an improved survival. This may be due the fact that rectal cancer surgery (TME) is associated with a high complication rate so substantial proportion of patients cannot receive chemotherapy postoperatively. An alternative approach is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor short-course radiotherapy (5 days) is given, as different studies showed local control of the tumor for a long time. During this waiting period the patient is in a good condition to receive an optimal dose of chemotherapy. The investigators hypothesize that with this proposed protocol both the local tumour and possible micrometastases are effectively treated and that this will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy.

Key Dates

Start date
Jun 21, 2011
Status verified
Apr 2026
Primary completion
Mar 8, 2020
Completion
Dec 31, 2026

Study Design

Enrollment
920 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B: 5x5Gy -> CAPOX -> surgery
    experimental group (arm B) M1 scheme: 5 fractions of 5 Gy external beam radiation (5x5Gy) followed by CAPOX followed by TME surgery
  • Active Comparator: A: 5 weeks chemoradiation -> surgery
    control group (arm A) standard long course chemoradiotherapy followed by TME surgery

Primary Outcome Measure

Number of Patients With Disease Related Treatment Failure (DrTF) [ Time Frame: 3 years follow-up after surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Siteman Cancer Center, Washington University Medical SchoolSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
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By specialty
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By research site
Siteman Cancer Center, Washington University Medical School· St Louis, MO

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