Clinical trial · Interventional
Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy and FOLFOX Chemotherapy for Rectal Cancer
Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy (BT) FOLFOX Chemotherapy for Stage II/III Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants were enrolled
Summary
Brief summary (as posted)
Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy given with chemotherapy at the same time. External beam radiation can increase side effects both short and long-term by exposing normal tissue nearby the tumor such as the bladder, bowel and sexual organs. Instead, this study will use a different way of delivering radiation called brachytherapy to decrease normal tissue radiation exposure. Patient will be given three chemotherapy medications both before and after surgery: oxaliplatin (also called EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic Acid). The purpose of this study is to find out whether giving chemotherapy and brachytherapy before surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the risk of tumor recurrence 3) avoid patient having the side effects related to chemotherapy and external beam radiation therapy and 4) improve patient's ability to complete chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Rate Endorectal Brachytherapy (HDR-ERBT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- This is a single arm study.
- interventionNames
- Radiation: High Dose Rate Endorectal Brachytherapy (HDR-ERBT)
Primary outcomes (1)
- measure
- Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy (BT) Improve Compliance
- timeFrame
- five years
- description
- Investigator propose combining pre-operative FOLFOX chemotherapy with high dose rate endorectal brachytherapy followed by surgery and then additional FOLFOX chemotherapy to further improve compliance.
Secondary outcomes (4)
- measure
- Locoregional failure
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the rectum * T2/3 tumors at ≤ 12cm from the A-V margin (below the peritoneal reflection) * Tumors with a lumen to allow the positioning of the rectal applicator. * Tumor of less than 3.5cm thickness documented at the CT Simulator * Patient should be a suitable candidate for surgery and chemotherapy * ECOG/WHO performance status 0-1 * Age 18 or older * No previous history of pelvic radiation or chemotherapy * Adequate marrow reserve, with absolute neutrophil count greater than or equal to 1.5 x 109/L and platelets greater than or equal to 100 x 109/L. * Serum creatinine \<= 1.5 x ULN; bilirubin \<= 1.5 x ULN; ALT\<= 2.5 x ULN * Non pregnant, non-lactating females under active contraception * No peripheral neuropathy \> grade 2 Exclusion Criteria: * Evidence of necrotic pelvic nodes or ≥ 1 cm * Evidence of distant metastasis * Previous pelvic radiation * Other cancer except for non-melanomatous carcinoma of the skin or CIS of the cervix. * Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy). * Use of any investigational agent within the 4 weeks preceding enrolment * Exposure to chemotherapy during the neoadjuvant phase * Documented distant metastases * Significant neuropathy * History of allergic reactions to platin compounds or 5-FU or leucovorin * Uncontrolled intercurrent illness such as active infection, congestive heart failure or coronary artery disease. * Psychiatric illness that would limit compliance with study requirements * Pregnancy or lactation * HIV infection
References
Publications (0)
Data not yet available