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NCT Number: NCT00979680

Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Sainte catherine, Avignon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
  • Tumor classified as EER UT2-UT3, whatever the nodal status
  • pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
  • Age 18 years or older
  • Informed and written consent

Exclusion criteria

  • T1
  • T4 (proven invasion of sphincter)
  • Diffuse metastatic syndrome (no curative intent, short expected life span)
  • preoperative incontinence (non due to the tumor)

Treatment and study plan

High-Dose radiotherapy

Radiation

Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.

Other names: HDRT

Chemo-radiotherapy

Radiation

Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.

Other names: CTRT

Primary outcomes

  1. Sphincter preservation rate

    Time frame: surgery

Secondary outcomes

  1. Tumor response according to rectal endo-echography

    Time frame: prior to surgery

  2. operative mortality and morbidity

    Time frame: after surgery

  3. anatomopathology margins (lateral and inferior)

    Time frame: after surgery

  4. Functional results (stoma closure, continence, manometry)

    Time frame: 2 years

  5. Local recurrence

    Time frame: 3 years

  6. Disease-free survival

    Time frame: 3 years

  7. Overall Survival

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

Acronym: GRECCAR1

Important dates

Study start
2001
Study completion
2007
First posted
Sep 18, 2009
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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