Rectal Cancer
Conditions
Keywords
Rectal cancer, Non-operative management
Brief 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.
Interventions
RADIATIONRadiotherapy boost
Additional endorectal high rate irydium brachytherapy boost, 2 fractions of 10 Gy each.
DRUGAdditional consolidation chemotherapy
Three additional cycles of 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4) consolidation chemotherapy
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A dose escalation study, either radiotherapy dose escalation or chemotherapy dose escalation.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Adenocarcinoma of the rectum classified clinically as T2, T3a-c or T4b but only with superficial infiltration of the vagina or prostate; tumour accessible by digital rectal examination; tumour ≤5 cm in length and ≤50% of rectal circumferential extent; N0-N2, but mesorectal node \<7 mm and no lateral nodes enlargement); extramural vascular invasion but not larger than 7 mm in the largest dimension; M0. 2. Operable patient 3. Patient having read the information note and having signed the informed consent 4. Follow-up possible
Exclusion criteria
1. Inoperable patient 2. cT1, cT3d, large T4, tumour ≥5cm or ≥50 of rectal circumferential extent 3. Enlargement of lateral nodes or any node ≥8 mm in diameter 4. Patient presenting metastasis at diagnosis 5. Previous pelvic irradiation 6. Simultaneous progressive another cancer 7. Close follow-up uncertain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with clinical complete response. | 15 weeks from the radiation start | Clinical complete response will be assessed by digital rectal examination, endoscopy and MRI. The analysis will take place 6 months after the start of treatment of a last enrolled patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regrowth rate. | From 12 months to 26 months from the radiation start. | Regrowth rate will be accessed at 2 years in patients undergoing watch-and-wait. The analysis will take place 12 months after the start of treatment of a last enrolled patient. |
| Anorectal function. | One year after the radiation start. | Anorectal function will be assessed by LARS scale before treatment and one year after the radiation start. |
| Acute and late toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5. | From 12 months to 26 months from the radiation start. | Acute and late toxicity will be assessed by CTCAE v.5 scale. |
Countries
Poland
Contacts
Primary ContactKrzsztof Bujko, Prof.
Outcome results
None listed