Clinical trial · Interventional
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
NCT02353858CI-TRIAL-00031652HT01completedPhase 2ClinicalTrials.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)
The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deep Regional Hyperthermia | — | UNRESOLVED | — |
| Hyperthermia | — | UNRESOLVED | — |
| Hyperthermic Chemoradiotherapy | — | UNRESOLVED | — |
| Hyperthermic Radiochemotherapy | — | UNRESOLVED | — |
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy (5-Fluorouracil) | Drug | — | UNRESOLVED |
| Deep regional hyperthermia | Other | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RtChx + Hyperthermia
- description
- Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week
- interventionNames
- Other: Deep regional hyperthermia
- Radiation: Radiotherapy
- Drug: Chemotherapy (5-Fluorouracil)
Primary outcomes (1)
- measure
- Pathological complete response rate
- timeFrame
- After surgical resection (4-6 weeks after last radiotherapy fraction)
Secondary outcomes (7)
- measure
- Locoregional progression free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge) * International Union Against Cancer stages II or III * ECOG PS 0/2 * Informed consent Exclusion Criteria: * Congestive heart failure (NYHA III/IV) * History of myocardial infarction within the last 6 months. * AV Block III * Total hip replacement or major metal pelvic implants * Cardiac pacemaker * Contraindications for radiochemotherapy * Contraindications for surgical tumor resection * Previous pelvic radiotherapy or chemotherapy * Active chronic inflammatory bowel disease * Collagenosis * Congenital diseases with increased radiosensitivity * Pregnancy or breastfeeding * Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal
References
Publications (1)
- DERIVEDGani C, Lamprecht U, Ziegler A, Moll M, Gellermann J, Heinrich V, Wenz S, Fend F, Konigsrainer A, Bitzer M, Zips D. Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial. Radiother Oncol. 2021 Jun;159:155-160. doi: 10.1016/j.radonc.2021.03.011. Epub 2021 Mar 17. PMID 33741467