Clinical trial · Interventional
Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy 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)
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
| Stage III Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (oxaliplatin, fluorouracil, EBRT)
- description
- Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: oxaliplatin
- Drug: fluorouracil
- Radiation: external beam radiation therapy
Primary outcomes (4)
- measure
- The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas
- timeFrame
- 7 days
- measure
- Progression-free survival
- timeFrame
- From protocol entry until documented progression of disease or death from any cause, assessed up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy
* Locally advanced disease defined as any of the following:
* Fixed or immovable tumor on physical exam
* T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI
* T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI
* No distant metastatic disease
* Performance status - ECOG 0-2
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT/SGPT no greater than 2.5 times ULN
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse
* No prior or concurrent evidence of neuropathy
* No history of allergy to platinum compounds or antiemetics
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior fluorouracil or platinum-based therapy for any malignancy
* No other concurrent chemotherapy
* Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone)
* No prior pelvic irradiation
* No concurrent antiretroviral therapy (HAART) for HIV positive patientsReferences
Publications (0)
Data not yet available