Clinical trial · Interventional
Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer
Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy together with chemotherapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase I trial is studying the side effects and best dose of neoadjuvant intensity-modulated radiation therapy with incorporated boost when given together with capecitabine in treating patients with locally advanced rectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Acute toxicity by CTCAE at 6 weeks following study completion
Secondary outcomes (1)
- measure
- Quality of life as assessed by Quality of Life Questionnaire Core 30 Items (QLQ-C30) before and after radiotherapy and then every 6 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary adenocarcinoma of the rectum
* Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam
* Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:
* Physical exam
* Transrectal ultrasound
* Pelvic CT scan
* Pelvic MRI
* No clinical evidence of metastatic disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* More than 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No known, uncontrolled coagulopathy
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT and SGPT ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times normal
* Creatinine clearance \> 50 mL/min
Cardiovascular
* No clinically significant cardiac disease
* No congestive heart failure
* No symptomatic coronary artery disease
* No poorly controlled cardiac arrhythmias
* No myocardial infarction within the past year
Gastrointestinal
* No active inflammatory bowel disease
* No lack of physical integrity of the upper gastrointestinal tract
* No malabsorption syndrome
Other
* No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
* No concurrent serious, uncontrolled infection(s)
* No prior unanticipated severe reaction to fluoropyrimidine therapy
* No known sensitivity to fluorouracil
* No prior uncontrolled seizures
* No CNS disorders that would preclude study participation
* No other medical or psychiatric condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy for rectal cancer
Chemotherapy
* No prior chemotherapy for rectal cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for rectal cancer
* No prior pelvic radiotherapy
Surgery
* More than 4 weeks since prior major surgery and recovered
* No prior surgery for rectal cancer
Other
* More than 4 weeks since prior participation in another investigational drug study
* No concurrent celecoxibReferences
Publications (0)
Data not yet available