{"entity":{"id":"fortplus","kind":"trial","name":"FORTplus","aka":["FORTplus trial","Early Stage Follicular Lymphoma and Radiotherapy plus Anti-CD20 Antibody"],"tldr":"A trial testing whether a radiotherapy dose one sixth of the standard works as well for early follicular lymphoma when an antibody is given alongside it.","summary":"Two pieces of evidence pull in opposite directions here. The FoRT trial found 4 Gy of radiotherapy inferior to 24 Gy for indolent lymphoma on response and progression-free survival. The MIR study and TROG 99.03 found that adding an anti-CD20 antibody to localised radiotherapy improves outcomes, and the GAZAI study reported a high complete response rate with 2 by 2 Gy combined with obinutuzumab.\n\nFORTplus tests whether the antibody makes the low dose safe. Its first question is the non-inferiority of 4 Gy given with an anti-CD20 antibody; if that holds, its second is whether obinutuzumab with low-dose radiotherapy is superior to rituximab with the standard dose, tested on the same set. The primary endpoint is morphological complete response, with primary completion estimated for 30 September 2027 at German sites.\n\nThe prize the trial is playing for is explicit in its protocol: a radiation dose reduced to 16 per cent of the standard, which would change how early follicular lymphoma is treated everywhere, including in settings where radiotherapy capacity is the binding constraint.","status":"active","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT05045664","url":"https://clinicaltrials.gov/study/NCT05045664"},{"label":"FoRT long-term follow-up, Lancet Oncology 2021","url":"https://doi.org/10.1016/S1470-2045(20)30686-0"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["radiation","immunotherapy"],"technologies":["radiotherapy","monoclonal-antibody"],"targets":["cd20"],"drugs":["rituximab","obinutuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":["complete-response","non-inferiority"],"trials":["trog-99-03"],"people":[],"bottlenecks":["b-surgery-radiation-innovation","b-global-access","b-toxicity-qol"],"keyPapers":["paper-fort-4gy-vs-24gy-indolent-lymphoma-hoskin-lancet-oncol-2014","paper-fort-long-term-follow-up-hoskin-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05045664","phase":"3","setting":"Early-stage follicular lymphoma: low-dose radiotherapy of 4 Gy with an anti-CD20 antibody against standard-dose radiotherapy with rituximab, and obinutuzumab against rituximab","sponsor":"Heidelberg University","started":"2022-07-06","startedType":"actual","enrolled":100,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/fortplus/","neighbours":{"cancer":[{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"},{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"}],"term":[{"id":"complete-response","kind":"term","name":"Complete response","route":"/terms/complete-response/"},{"id":"non-inferiority","kind":"term","name":"Non-inferiority trial","route":"/terms/non-inferiority/"},{"id":"radiotherapy","kind":"term","name":"Radiotherapy","route":"/terms/radiotherapy/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"trial":[{"id":"gallium","kind":"trial","name":"GALLIUM","route":"/trials/gallium/"},{"id":"trog-99-03","kind":"trial","name":"TROG 99.03","route":"/trials/trog-99-03/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"paper":[{"id":"paper-fort-long-term-follow-up-hoskin-lancet-oncol-2021","kind":"paper","name":"FoRT long-term follow-up: 4 Gy versus 24 Gy for follicular and marginal zone lymphoma","route":"/key-papers/paper-fort-long-term-follow-up-hoskin-lancet-oncol-2021/"},{"id":"paper-fort-4gy-vs-24gy-indolent-lymphoma-hoskin-lancet-oncol-2014","kind":"paper","name":"FoRT: 4 Gy versus 24 Gy radiotherapy for indolent lymphoma, a randomised phase 3 non-inferiority trial","route":"/key-papers/paper-fort-4gy-vs-24gy-indolent-lymphoma-hoskin-lancet-oncol-2014/"},{"id":"paper-trog-99-03-radiotherapy-systemic-therapy-early-follicular-jco-2018","kind":"paper","name":"Randomized trial of systemic therapy after involved-field radiotherapy in patients with early-stage follicular lymphoma: TROG 99.03","route":"/key-papers/paper-trog-99-03-radiotherapy-systemic-therapy-early-follicular-jco-2018/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}]}}