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Neoadjuvant Treatment for Advanced Rectal Carcinoma

NCT02551237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-10-13

No results posted yet for this study

Summary

The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

Conditions

  • Rectal Carcinoma

Interventions

RADIATION

50 Gy

radiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks

DRUG

Capecitabine

oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy.

RADIATION

25 Gy

radiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm)

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Eric Francois · Centre Antoine Lacassagne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-07
Primary Completion
2020-08-29
Completion
2022-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02551237 on ClinicalTrials.gov