Planned Non-operative Management for Rectal Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Radiation: Radiotherapy boost; Drug: Additional consolidation chemotherapy

• Registration Number: NCT05241574
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-03
• Study First Submitted: 2022-01-25
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-04
• Last Update Submitted: 2022-02-04
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
radiotherapy dose escalation	Radiotherapy boost	Additional two fractions of endorectal high dose rate iridium brachytherapy boost, 10 Gy each.
chemotherapy dose escalation	Additional consolidation chemotherapy	Additional three cycles of consolidation chemotherapy consisted of 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M. Skłodowska-Curie National Research Institute of Oncology; 🇵🇱 Warsaw, Poland