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NCT03800212: AMPULLOMA
Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma
trial testing treatment for ampullary adenocarcinoma in Ampullary Adenocarcinoma in 402 participants. Status unknown.
15 December 2022
Quick facts
| Lead sponsor | Federation Francophone de Cancerologie Digestive |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 402 |
| Start date | 7 July 2017 |
| Primary completion | 15 December 2022 |
| Estimated completion | 15 December 2022 |
| Sites | 36 locations across France |
Drugs / interventions tested
- treatment for ampullary adenocarcinoma — full drug profile →
Conditions studied
- Ampullary Adenocarcinoma — all drugs for Ampullary Adenocarcinoma →
Sponsor
Federation Francophone de Cancerologie Digestive — full company profile →
Who can join
18 and older, any sex, with Ampullary Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established.In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A simple prognostic score to predict recurrence after pancreaticoduodenectomy for ampullary carcinoma: results from the French prospective FFCD-AC cohort.
Roth G, Pellat A, Piessen G, le Malicot K, et al · · 2024 · cited 2× · PMID 39561623 · DOI 10.1016/j.esmoop.2024.103988
Verify or expand the search:
- PubMed search for NCT03800212
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ampullary Adenocarcinoma
Currently open trials in the same condition.
- NCT06068023 — The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. · recruiting
- NCT05116072 — Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula · Phase 1, PHASE2 · recruiting
Other Federation Francophone de Cancerologie Digestive trials
Trials by the same sponsor.
- NCT07124858 — Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metast · NA · not yet recruiting
- NCT07150403 — Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) P · Phase 2 · not yet recruiting
- NCT07270991 — Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma · Phase 3 · recruiting
- NCT07128290 — PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma · Phase 2 · not yet recruiting
- NCT07124884 — 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non- · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03800212 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federation Francophone de Cancerologie Digestive
- Last refreshed: 24 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03800212.
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