Clinical trial · Interventional
Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III 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 |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy, Chemotherapy and Surgery
- interventionNames
- Drug: fluorouracil
- Drug: leucovorin calcium
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Frequency of toxicity
- timeFrame
- weekly during treatment
- measure
- tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy
- timeFrame
- during radiation therapy and chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum * Tumor extending through bowel wall (T3) OR * Fixation to surrounding structures (T4) OR * Nodal involvement by endorectal ultrasound (N1-2) * Tumor extending through bowel wall, but not fixed (T3) must be: * At least 4 cm or at least 40% of bowel circumference OR * Accompanied by nodal involvement * Evidence of transmural penetration confirmed by 2 of the following: * CT scan * Pelvic MRI * Transrectal ultrasound * Physical exam * Proximal extent of tumor must not extend higher than 12 cm above dentate line and must be below pelvic peritoneal reflexion or sacral promontory * Regional lymph node involvement allowed * No distant metastases by CT scan of abdomen and pelvis or chest x-ray PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-1 * Life expectancy: At least 2 years * Hematopoietic: * Leukocyte count greater than 4,000/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin greater than 10 g/dL * Hepatic: * SGOT and SGPT less than 1.5 times normal * Bilirubin less than 1.5 mg/dL * Renal: Creatinine less than 1.8 mg/dL * Other: * Not pregnant or nursing * Negative pregnancy test * No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix * No psychiatric condition that would preclude informed consent * No other serious medical illness that would limit survival PRIOR CONCURRENT THERAPY: * Biologic therapy: Not specified * Chemotherapy: No prior chemotherapy for rectal cancer * Endocrine therapy: Not specified * Radiotherapy: No prior radiotherapy for rectal cancer * Surgery: No prior surgery for rectal cancer, except diagnostic biopsy
References
Publications (0)
Data not yet available