Looking for volunteers
Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
NCT03465982 · Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Updated 16 April 2024
- What is being tested
- Surgery after 8 weeks from chemoradiation treatment; Surgery after 12 weeks from chemoradiation treatment
- For
- Rectal Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 340 people. The full rules are on the registry page.
- Where
- Italy (14 sites)
- When
- Starts or started 5 June 2018, ends 5 June 2029. Registered 15 March 2018.
- Results
- None posted yet.
In the researchers' words
The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.
Sites
- SS. Antonio e Biagio e Cesare Arrigo HospitalAlessandria, AL, Italy
- Ospedale Gian Battista Morgagni - Luigi PierantoniForlì, Forlì-Cesena, Italy
- Ospedale Civile Pietro CosmaCamposampiero, Padua, Italy
- Ospedale Sacro CuoreNegrar, Verona, Italy
- Ente Ecclesiastico ospedale generale Regionale MiulliAcquaviva delle Fonti, Italy
- Ospedale degli InfermiBiella, Italy
- Istituto del Radio Olindo Alberti, Spedali Civili di BresciaBrescia, Italy
- ASST Ospedale di CremonaCremona, Italy
- Azienda Ospedaliera Universitaria CareggiFlorence, Italy
- Ospedale Maggiore Policlinico Fondazione Ca' GrandaMilan, Italy
- Ospedale San Raffaele IRCCSMilan, Italy
- Istituto Nazionale Tumori - IRCCS Fondazione G. PascaleNaples, Italy
- Ospedale San FrancescoNuoro, Italy
- Azienda Ospedaliera San Giovanni - AddolorataRoma, Italy