Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study

NCT00624260 | Completed DMC

• 1 other identifier: P070142
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. Nevertheless, current consensual morphological and biological examinations are not very contributory, of difficult interpretation and expensive. The metabolic imagery in tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows detecting more often recurrences accessible to a curative surgery. We make the hypothesis that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC allows to decrease non curative recurrences appearance during the 3 years follow-up after a curative surgery.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Recurrence; Positron Emission Tomography; Colorectal Cancer with high risk of recurrence stage III; Colorectal Cancer with high risk of recurrence stage IV; T4N0M0 operated in emergency( because of perforation)

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a non removable recurrence

  at the end of the study

Secondary Outcomes (3)

• Survival without non removable tumor

  At the end of the study

• Overall survival

  At the end of the study

• Cost of the strategy

  At the end of the study

Study Arms (2)

2

ACTIVE COMPARATOR

Usual follow up : Pet-TDM for current indication (high isolated markers or before a metastasis curative resection)

Other: PET-TDM for current indication

1

EXPERIMENTAL

Semi-annual systematic PET-TDM (M6, M12, M18, M24, M30 and M36 after initial surgery)

Other: semi-annual systematic PET-TDM

Interventions

semi-annual systematic PET-TDM OTHER

semi-annual systematic PET-TDM

1

PET-TDM for current indication OTHER

PET-TDM for current indication (high isolated markers or before a metastasis curative resection)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a removed colorectal adenocarcinoma since less than 6 months, in total remission and for whom a monitoring is necessary to detect recurrences precociously.
• Patients with a T4N0M0 tumour and operated in emergency (because of a tumoral perforation) can be included. (suppressed by amendment 1)
• before criteria have been replaced by : Patients with colorectal adenocarcinoma which is histologically proved and classified stage II perforated, III or IV, totally removed, in total remission,
• if no metastatic, removed surgery must have been done since less 6 months;
• if metastatic, all metastasis would have been removed, the last surgery dating less 6 months.(amendment 1)
• Casual extension check-up would have been realized before initial surgery or during a period of 6 months after surgery performed in emergency.
• informed consent signed
• Age ≥ 18 years
• Patient in ability to undergone hepatic or pulmonary resection in case of recurrence during the follow-up (ECOG ≤ 2)
• Willingness to control visits

You may not qualify if:

• pregnant or breast feeding women, or with a reproductive potential and no practicing an effective method of contraception during the second part of ovarian cycle ( PET is realised during the first part of ovarian cycle)
• Cancer stage I or II (except T4 operated in emergency) or IV without possibility to remove metastasis or R2 after surgery.
• Performance status contraindicating a hepatic or pulmonary surgery in case of recurrence.
• Patients likely to undergone chemotherapy, surgery or radiotherapy during 2 weeks before PET-TDM.
• Other progressive tumoral affection known, or colorectal cancer in progression.
• (Bad compliance to the study procedure.)(suppressed by amendment 1)
• Not balanced diabetes. (added by amendment 1)
• Patients included in others clinical trials of imagery.
• Inability to provide informed consent signed.
• No social assurance.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Henri Mondor

Créteil, 94000, France

Location

Related Publications (1)

• Sobhani I, Itti E, Luciani A, Baumgaertner I, Layese R, Andre T, Ducreux M, Gornet JM, Goujon G, Aparicio T, Taieb J, Bachet JB, Hemery F, Retbi A, Mons M, Flicoteaux R, Rhein B, Baron S, Cherrak I, Rufat P, Le Corvoisier P, de'Angelis N, Natella PA, Maoulida H, Tournigand C, Durand Zaleski I, Bastuji-Garin S. Colorectal cancer (CRC) monitoring by 6-monthly 18FDG-PET/CT: an open-label multicentre randomised trial. Ann Oncol. 2018 Apr 1;29(4):931-937. doi: 10.1093/annonc/mdy031.

  PMID: 29365058 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Iradj Sobhani, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

FR (1)