Clinical trial · Interventional
Chemoradiation or Brachytherapy for Rectal Cancer
Chemoradiation OR Brachytherapy for RECTal Cancer
NCT02017704CI-TRIAL-00070524CORRECTcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is being done to compare the effectiveness of high dose endorectal brachytherapy (END-HDR) and the standard treatment option of chemoradiation with Capecitabine in the treatment of cancer of the lowest part of the bowel (rectum).
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine and IMRT (if randomized to this arm) | Drug | — | UNRESOLVED |
| Endo-HDR (if randomized to this arm) | Radiation | — | UNRESOLVED |
| FOLFOX6 | Drug | FOLFOX-6 Regimen | ALIAS |
| IMRT (intensity modulated radiation therapy) | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IMRT and Capecitabine
- description
- Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications Followed by: * Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion * 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions * 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks) Duration of treatment: 12 cycles Then: Surgical Resection
- interventionNames
- Drug: capecitabine and IMRT (if randomized to this arm)
- Radiation: IMRT (intensity modulated radiation therapy)
- Drug: FOLFOX6
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Endo-HDR
- description
- Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by: * Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion * 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions * 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks) Duration of treatment: 12 cycles Then: Surgical Resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed adenocarcinoma of the rectum * Appropriate tumor staging and location * Patients should be suitable candidates for surgery and chemotherapy * ECOG/WHO performance status 0-1 * Patients must be 18 years or older * No previous history of pelvic radiation * Patients must have acceptable organ and marrow function * Non pregnant, non-breast feeding females under active contraception * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Evidence of distant metastatic disease * Evidence of sphincter invasion on MRI * Prior history of radiation to the pelvis * Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, DCIS, or other cancer from which the patient has been disease free for at least 3 years * Presence of multiple small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy). * Use of any investigational agent within the 4 weeks preceding enrollment * Previous exposure to chemotherapy for rectal cancer * Uncontrolled intercurrent illness including but not limited to, ongoing or active infections (or infections requiring systemic treatment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and breastfeeding women are excluded, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately. * Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test. * Contraindication for safe MRI, implants, or other conditions that interfere with imaging required for the study (e.g., pacemaker or non-MRI compatible hip prostheses). Note: Subjects with bilateral hip implants are not eligible for the study. Subjects with a unilateral hip implant may be eligible assuming the implant is MRI compatible and does not present artifact on MRI in the areas of interest. * Subject is pacemaker dependent.
References
Publications (0)
Data not yet available
No reference posted for this study.