SURVEILLANCE: Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer

Sponsor

Federation Francophone de Cancerologie Digestive (Other)

Overall Status

Completed

CT.gov ID

NCT00995202

Collaborator

(none)

1,997

Enrollment

117

Locations

Arms

141

Actual Duration (Months)

17.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Procedure: Standard Monitoring CEA Procedure: Intensive Monitoring CEA Procedure: Standard Monitoring Imagery Procedure: Intensive Monitoring Imagery	Phase 3

Detailed Description

OBJECTIVES:

Evaluate the efficacy of reinforced versus standard follow-up care and the utility of follow-up CEA assessments in patients with fully resected stage II or III colorectal cancer.

OUTLINE: This is a multinational/multicenter study. Patients are randomized to 1 of 2 follow-up arms.

Standard follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo abdominal ultrasound every 3 months until year 3 and then every 6 months until year 5; chest x-ray every 6 months until year 3 and then annually until year 5; and colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
Reinforced follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo alternate assessments every 3 months comprising thoraco-abdomino-pelvic CT scan or abdominal ultrasound until year 3 and then every 6 months until year 5. They also undergo colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.

Patients undergo a second randomization to 1 of 2 follow-up arms at the beginning of the study.

CEA measurement: Patients undergo measurement of CEA levels every 3 months until year 3, every 6 months until year 5, and at least yearly thereafter.
No CEA measurement: Patients do not undergo CEA measurement. Blood and tissue blocks of normal and tumor tissues are collected for the validation of protein serum, genetics, or immunologic markers predictive for relapse.

Study Design

Study Type:

Interventional

Actual Enrollment :

1997 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

This study is a surveillance study not an interventional study with productsThis study is a surveillance study not an interventional study with products

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

Actual Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard Monitoring CEA/ Standard Imagery No specific follow-up of CEA and Standard imagery	Procedure: Standard Monitoring CEA No specific follow-up of CEA Procedure: Standard Monitoring Imagery Abdominal ultrasound examination every 3 months during 3 years then every 6 months during 2 years then annually. Chest X-ray examination eveyr 6 months during 3 years then annually during 2 years
Other: Intensive monitoring CEA/ Standard Imagery Intensive follow-up CEA and Standard imagery .	Procedure: Intensive Monitoring CEA CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years. Procedure: Standard Monitoring Imagery Abdominal ultrasound examination every 3 months during 3 years then every 6 months during 2 years then annually. Chest X-ray examination eveyr 6 months during 3 years then annually during 2 years
Other: Intensive Monitoring CEA / Intensive Monitoring Imagery Intensive follow-up CEA and Intensive imagery	Procedure: Intensive Monitoring CEA CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years. Procedure: Intensive Monitoring Imagery Alternation every 3 months of TDM thoraco-abdomino-pelvis and abdominal ultrasound examination during 3 years and twice a year after during 2 years. Coloscopy at 3 years and then evry 5 years if normal
Other: Standard Monitoring CEA/ Intensive Monitoring Imagery No specific follow-up of CEA and Intensive Imagery	Procedure: Standard Monitoring CEA No specific follow-up of CEA Procedure: Intensive Monitoring Imagery Alternation every 3 months of TDM thoraco-abdomino-pelvis and abdominal ultrasound examination during 3 years and twice a year after during 2 years. Coloscopy at 3 years and then evry 5 years if normal

Outcome Measures

Primary Outcome Measures

Overall survival rate [5 years]
Time between randomization and date of death (all causes)

Secondary Outcome Measures

Disease-free survival rate [5 years]
Time between randomization and first recurrence (local or metastatic) or death (all causes)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Pathologically confirmed adenocarcinoma of the colon or rectum
Stage II or III disease
No distant metastatic disease
Has undergone curative resection for no residual tumor
Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery

PATIENT CHARACTERISTICS:

WHO performance status 0-1
Not pregnant or nursing
Fertile patients must use effective contraception
No inflammatory bowel disease
No other malignancy within the past 5 years except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix
No genetic syndromes

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Locations

	Site	City	Country
1	Clinique Sud Luxembourg	Arlon	Belgium
2	CH	Abbeville	France
3	Clinique Isabelle	Abbeville	France
4	CHU Nord	Amiens	France
5	CHU	Angers	France
6	CH	Antibes	France
7	CH	Aubenas	France
8	CH	Auch	France
9	CH	Auxerre	France
10	Polyclinique Ste Marguerite	Auxerre	France
11	CH Henri Duffaut	Avignon	France
12	Clinique Sainte Cahterine	Avignon	France
13	Centre d'oncologie et de radiothérapie du Pays Basque	Bayonne	France
14	CH	Beaune	France
15	CH	Beauvais	France
16	CHU J Minjoz	Besançon	France
17	CH	Blois	France
18	CH	Bobigny	France
19	Polyclinique Nord Aquitaine	Bordeaux	France
20	CH Duchenne	Boulogne Sur Mer	France
21	CH	Bourg en Bresse	France
22	Hôpital du Morvan	Brest	France
23	CH	Briey	France
24	Centre de Radiothérapie et d'oncologie médicale	Béziers	France
25	CH	Béziers	France
26	CHIC	Castres	France
27	CH	Challans	France
28	Hôpital Sainte Marie	Chalon sur Saone	France
29	CH	Chambery	France
30	Clinique du Cléret et Clinique Saint Joseph	Chambery	France
31	CH	Cholet	France
32	CH	Châlons en Champagne	France
33	CHU Estaing	Clermont Ferrand	France
34	Hôpital Pästeur	Colmar	France
35	CH	Compiegne	France
36	Clinique des 2 Caps	Coquelles	France
37	Clinique des Cèdres	Cornebarrieu	France
38	Clinique des Acacias	Cucq	France
39	CH	Dax	France
40	Cabinet d'HGE - Cours De Gaulle	Dijon	France
41	Cabinet Privé Point Médical	Dijon	France
42	Centre d'Oncologie Médicale du Parc	Dijon	France
43	CHU le bocage	Dijon	France
44	CH	Draguignan	France
45	Clinique Saint Vincent	Epernay	France
46	Centre médical de Forcilles	Ferolles Attilly	France
47	CHI Saint Raphael	Frejus	France
48	CHI	Gap	France
49	Institut Hollard	Grenoble	France
50	CH	Haguenau	France
51	CHD	La Roche sur Yon	France
52	CH	Lagny sur Marne	France
53	CH Louis Pasteur	Le Coudray	France
54	CH	Le Havre	France
55	CH	Le Mans	France
56	Hôpital Robert Boulin	Libourne	France
57	Centre Oscar Lambret	Lille	France
58	CHG	Longjumeau	France
59	Clinique des 4 pavillons	Lormont	France
60	CHU Lyon Sud	Lyon	France
61	CH	Macon	France
62	Polyclinique du Val de Saône	Macon	France
63	CH Saint Joseph	Marseille	France
64	CHU La Timone	Marseille	France
65	Hôpital Européen	Marseille	France
66	Hôpital Nord	Marseille	France
67	Hôpital Layné	Mont de Marsan	France
68	CH	Montbrison	France
69	CH	Montceau Les Mines	France
70	CH	Montelimar	France
71	CHI Le Raincy Montfermeil	Montfermeil	France
72	Centre Azuréen de Cancérologie	Mougins	France
73	Hopital Americain de Paris	Neuilly-Sur-Seine	France
74	Polyclinique Val de Loire	Nevers	France
75	Hôpital l'Archet II	Nice	France
76	CHU Carémeau	Nimes	France
77	Clinique Valdegour	Nimes	France
78	CHR - Sce D'HGE	Orléans	France
79	CHR - Sce d'Oncologie	Orléans	France
80	Hôpital Privé Les Peupliers	Paris	France
81	Hôpital Saint Louis	Paris	France
82	CH	Pau	France
83	Polyclinique Francheville	Perigueux	France
84	Centre Catalan d'Oncologie	Perpignan	France
85	Hôpital Saint Jean	Perpignan	France
86	CHU Haut Lévèque	Pessac	France
87	Centre Hospitalier Annecy Genevois	Pringy	France
88	CH	Privas	France
89	CHU Robert Debré	Reims	France
90	Institut Jean Godinot	Reims	France
91	CHU Pontchaillou	Rennes	France
92	CH	Rodez	France
93	CH Romans	Romans-Sur-Isère	France
94	CH Yves Lefoll	Saint Brieuc	France
95	CHPG	Saint Chamond	France
96	CH	Saint Die Des Vosges	France
97	Polyclinique Côte Basque Sud	Saint Jean De Luz	France
98	Centre Joliot Curie	Saint Martin Boulogne	France
99	Clinique de la Côte d'Opale	Saint Martin Boulogne	France
100	Clinique Mutualiste de l'Estuaire - Cité Sanitaire	Saint Nazaire	France
101	CHU	Saint-Etienne	France
102	Hôpital Broussais	Saint-Malo	France
103	Clinique	Sainte-Colombe	France
104	Centre Médical National MGEN Alfred Leune	Sainte-Feyre	France
105	CH	Semur en Auxois	France
106	CH	Soissons	France
107	Centre Paul Strauss	Strasbourg	France
108	Hôpital Sainte Musse	Toulon	France
109	CH Gustave Dron	Tourcoing	France
110	CH Trousseau	Tours	France
111	CH	Valence	France
112	CHBA	Vannes	France
113	CH	Vernon	France
114	CH	Vesoul	France
115	CH Privé	Villeneuve D'Ascq	France
116	CH	Villeneuve Saint-Georges	France
117	CHU Clarac	Fort-de-France	Martinique