Clinical trial NCT03946033: Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer
Official title: A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonic Neoplasms
Keywords: Immunoscore Adjuvant Prospective Colon
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: HalioDx
First posted: 2019-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.

Detailed description: On previous studies, Immunoscore Colon test identified subgroups of stage II and III colon cancer patients whose Chemotherapy could be adjusted.

The study hypothesis is that Immunoscore Colon Test will modify the therapeutic decision in MM.

With Alpha and Beta at 5% and p0=10% modification rate, the participating investigators need to include 280 participants, 140 in each cohort (stage II and stage III).

Participants will have tumor samples from their curative surgery tested with Immunoscore Colon. When the patients are evaluated in MM, a first therapeutic decision will be taken before disclosing the test result. ICT result will then be communicated and a second decision will be taken.

Eligibility criteria: Inclusion Criteria:

* Cytologically/histologically proven colon adenocarcinoma
* non-metastatic cancer
* Stage II or III adenocarcinoma
* Surgical resection of primitive tumor within 6 weeks of multidisciplinary meeting
* No macroscopic or microscopic proof of residual disease during surgery (R0 margins)
* Available surgical material: FFPE tumor samples
* Post-operative adjuvant chemotherapy considered during multidisciplinary meeting
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Patient having signed a written informed consent prior to any trial specific procedures
* Patient affiliated to the social security system or equivalent

Exclusion Criteria:

* Other invasive cancer within 5 years of the colon cancer diagnosis, except for adequately treated basal cell carcinoma or squamous cell skin carcinoma or in sity cervical carcinoma
* Patients for which adjuvant chemotherapy is contra-indicated
* Any previous systemic or loco regional anticancer therapy for the studied colon cancer (e.g. neoadjuvant therapy)
* Patient enrolled or planned to be enrolled in another clinical trial that may influence the therapeutic decision
* Any psychological, social or geographical issue that may hinder the patient's understanding of the study or the study conduct
* Person deprived of liberty or under the authority of a legal guardian
* Person unable to understand the study or to comply with the protocol procedures

Primary outcomes:
measure: Modification rate of adjuvant therapeutic strategy
timeFrame: At the multidisciplinary meeting, up to 6 weeks after the cancer surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Blois
country: France
facility: Hôpital Simone Veil
city: Colmar
country: France
facility: Hospices civils de Colmar
city: Dijon
country: France
facility: CHU de Dijon
city: La Roche-sur-Yon
country: France
facility: CHD de Vendée
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital Jean Mermoz
city: Marseille
country: France
facility: Hôpital Européen Marseille
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
city: Nantes
country: France
facility: CHU Hôtel-Dieu
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: CHU de Bordeaux - Haut Lévêque
city: Poitiers
country: France
facility: CHU de Poitiers
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Thonon-les-Bains
country: France
facility: Hôpital du Léman
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeneuve-d'Ascq
country: France
facility: Hôpital privé de Villeneuve d'Ascq
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: David Malka, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pages F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Borger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grutzmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Leonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Musina AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, Galon J. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10.