Trials / Unknown
UnknownNCT05241574
Planned Non-operative Management for Rectal Cancer
Radio(Chemo)Therapy Dose Escalation in Non-operative Management for Rectal Cancer: A Prospective NOM-3 Observational Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The investigators propose to conduct an observational study on consecutive patients with low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal circumferential extent. The aim of this study is to test a hypothesis that escalation of either radiation or chemotherapy dose of the routine preoperative radio(chemo)therapy leads to an increase of clinical complete response rate. The planned sample size of 23 patients was calculated based on the assumption that clinical complete response rate after routine preoperative radio(chemo)therapy is 34% \[1\] and expected rate after radio(chemo)therapy dose escalation is 75% \[2-4\]. An endorectal high dose rate iridium brachytherapy boost (2 fractions of 10 Gy) will be added after the routine preoperative treatment consisted of external beam radiotherapy (5 × 5 Gy) combined with sequential 3 cycles of consolidation FOLFOX4. However, for patients with involvement of the anal canal, additional 3 cycles of consolidation FOLFOX4 (6 cycles in total) will be added instead of brachytherapy boost to avoid severe post-radiation toxicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiotherapy boost | Additional endorectal high rate irydium brachytherapy boost, 2 fractions of 10 Gy each. |
| DRUG | Additional consolidation chemotherapy | Three additional cycles of 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4) consolidation chemotherapy |
Timeline
- Start date
- 2021-08-03
- Primary completion
- 2023-10-01
- Completion
- 2023-10-01
- First posted
- 2022-02-15
- Last updated
- 2022-02-15
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT05241574. Inclusion in this directory is not an endorsement.