Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01609504
Other study ID # URBINO-LEZ-1995
Secondary ID
Status Completed
Phase Phase 3
First received September 15, 2011
Last updated May 29, 2012
Start date April 1997
Est. completion date April 2004

Study information

Verified date May 2012
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Interventional

Clinical Trial Summary

The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer after Neoadjuvant Treatment.


Description:

From April 1997 to April 2004, patients with cT2 rectal cancer and no suspicion for positive lymph-nodes or distant metastases (cN0 M0) were enrolled in this study.

History, routine laboratory tests including tumour markers, digital examination to evaluate tumour fixation and sphincter tone, clinical evaluation, were recorded for each patient in a data base.

At admission, staging included: 1) endorectal ultrasound (EUS) 2) rigid rectoscopy and tumour biopsies; 3) total colonoscopy with vital dye staining of the rectum and 6-8 standard biopsies of normal mucosa at a distance of approximately 1 cm around the tumour with India ink tattooing of biopsy sites; 4) helical Total Body Computerized Tomography (CT), and 5) pelvic magnetic resonance imaging (MRI). Rigid rectoscopy was performed in order to measure the exact distance of the tumour from the anal verge and to select the most appropriate patient's position on the operative table in case of TEM surgery.

Positive lymph-node status at imaging was established according to the following criteria:

1. at EUS, diameter > 0.8 cm, circular or irregular shape, hypervascularization at colour Doppler and hypoechogenicity.

2. at CT and MRI, diameter of > 0.8 cm, circular or irregular shape. All patients with suspicious nodes or contradictory response at EUS, CT or MRI T staging were not enrolled in the present study.

Inclusion criteria were: tumour located within 6 cm from the anal verge, tumour diameter not larger than 3 cm, and staged as cT2 N0 M0, G1-2. Patients classified as American Society of Anaesthesiologists (ASA) 3 or 4 were excluded.

All patients underwent preoperative radiotherapy. The total dose given was 50.4 Gy in 28 fractions over 5 weeks. The irradiated areas were: anus, rectum, mesorectum, regional and iliac lymph-nodes. Continuous infusion of 5-FU 200 mg/m2/day was performed during radiotherapy treatment.

Forty days after the end of NT, staging as described above (except for total colonoscopy) was repeated. Downsizing was classified in two groups: patients with tumour mass reduction more than 50% (responders) and patients with tumour mass reduction less than 50% (low or non responders). According to the study protocol, patients with disease progression were excluded.

Randomization was performed the day before operation. Patients were stratified in two groups and subsequently allocated 1:1 to the two arms of the study, ELRR by TEM (arm A) or LTME (arm B) by means of sealed opaque envelopes containing computer-generated random numbers. In the end, 50 patients underwent ELRR by TEM (arm A) and 50 patients underwent laparoscopic resection (LTME) (laparoscopic low anterior resection or abdominal-perineal resection) (arm B). The recruitment was interrupted when 100 patients had undergone operation.

Surgery was performed between 45 and 55 days after the end of radio-chemotherapy. Preoperative washout of the colon (polyethyleneglycol) and short-term antibiotic prophylaxis (metronidazole and second generation cephalosporin) were administered to all patients. Surgical procedures were performed only by two surgeons expert in open rectal surgery and skilled in both laparoscopic and TEM procedures.

TEM procedures were performed with the Wolf Company (Tuttlingen, Germany) instrumentation. The surgical technique of ELRR was as follows: mucosal incision included all the tattoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumour, according to its diameter before NT. Starting from the mucosal incision the dissection was continued deeply in order to remove all the mesorectum adjacent to the tumour, following a cutting line with an angle of approximatively 120-135° with respect to the mucosal plane. For posterior and lateral lesions the bottom dissection plane was carried down to the "holy plane" and for anterior lesions to the level of the vagina septum or the prostatic capsule. In case of tumour with the distal limit at the level of the anal canal, the incision included the dentate line and the internal sphincter fibres were partially removed. For distal tumours, in order to maintain the CO2 rectum insufflation it is recommended to adjust the rectoscope axis so as to keep its inferior circumference adherent to the anal canal. In all patients the defect was closed by multiple running stitches, according to the technique described by Buess.

The surgical technique of Arm B was laparoscopic low anterior resection or abdominal perineal resection.

Primary endpoint in this study was the oncological result in terms of local recurrence, distant metastases and cancer related mortality with minimum follow-up time of 5 years. Secondary endpoints were: operative time, blood loss, analgesic use, morbidity, hospital stay and 30 day mortality. Major morbidity was defined as complications requiring surgical treatment. In order to evaluate local and/or systemic recurrence, all patients were prospectively followed-up by clinical examination, tumour markers' assay and rectoscopy every 3 months for the first 3 years, then every six months. Total body CT, and pelvic MRI were repeated every 6 months for the first 5 years. According to the study protocol, no adjuvant therapy was administered, as recommended by the consultant oncologist in T2N0 rectal cancer patients.


Recruitment information / eligibility

Status Completed
Enrollment 283
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Tumor located within 6 cm from the anal verge

- Tumor diameter not larger than 3 cm, and staged as iT2, N0, G1-2

Exclusion Criteria:

- Patients classified as American Society of Anaesthesiologists (ASA) 3 or 4

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
ELRR BY TEM
The surgical technique of ELRR was as follows: mucosal incision included all the tatoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumor, according to its diameter before NT
LTME
LAPAROSCOPIC TOTAL MESORECTAL EXCISION INCLUDING MESORECTAL (ACCORDING TO HEALD CRITERIA)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Roma La Sapienza Università Politecnica delle Marche

Outcome

Type Measure Description Time frame Safety issue
Primary oncological result in term of local and/or systematic recurrence To evaluate local and/or systematic recurrence, all patients were followed up prospectively by clinical examination, measurement of tumour markers and sigmoidoscopy every 3 months for the first 3 years, and every 6 months thereafter. Whole-body CT and pelvic MRI were repeated every 6 months for the first 5 year. All patients had a minimum follow-up of 5 years. 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation Yes
Secondary Morbidity No. of patients with postoperative complications participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group No
Secondary operative time operative time (minutes) operative time No
Secondary blood loss blood loss (ml) during time of operation No
Secondary analgesic use No. of patients receiving analgesia participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group No
Secondary 30 day mortality No. of patients died within 30 days from operation at 30 days from operation Yes
Secondary hospital stay hospital stay (days) participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group No
Secondary cancer-related mortality No. of patients died for cancer. To evaluate local and/or systemic recurrence, all patients were followed up prospectively. After 5 year every 12 months. All patients had a minimum follow-up of 5 years 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation Yes
See also
  Status Clinical Trial Phase
Recruiting NCT06380101 - Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) N/A
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Recruiting NCT04323722 - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Active, not recruiting NCT01347697 - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer N/A
Recruiting NCT04495088 - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer Phase 3
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Not yet recruiting NCT03520088 - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS N/A
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Recruiting NCT04749381 - The Role of TCM on ERAS of Rectal Cancer Patients Phase 2
Enrolling by invitation NCT05028192 - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Recruiting NCT03283540 - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Recruiting NCT05914766 - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer N/A
Recruiting NCT04852653 - A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Terminated NCT02933944 - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer Phase 1