Clinical trial · Interventional
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer
Phase I Study of Preoperative Radiation Therapy With Concurrent Protracted Continuous Infusion 5-FU and Dose Escalating Oxaliplatin Followed by Surgery, 5-FU, and Leucovorin for Locally Advanced (T3 and T4) Rectal Adenocarcinoma
NCT00003799CI-TRIAL-00008847completedPhase 1ClinicalTrials.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)
Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by surgery and additional chemotherapy in treating patients who have advanced nonmetastatic primary cancer of the rectum. 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 an effective treatment for rectal cancer
Conditions
Conditions (9)
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 |
| Mucinous Adenocarcinoma of the Rectum | Rectal Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Signet Ring Adenocarcinoma of the Rectum | Rectal Signet Ring Cell Adenocarcinoma | ALIAS | 0.90 |
| Stage IIA Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, radiotherapy, surgery)
- description
- Patients receive fluorouracil IV continuously with concurrent radiotherapy for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on day 1 of weeks 1, 3, and 5. Patients undergo surgery 6-8 weeks after completing preoperative chemotherapy and radiotherapy. The surgical procedure is determined by the extent of the tumor before preoperative therapy. The type of operative procedure may be abdominoperineal resection, low anterior resection (LAR), or LAR/coloanal anastomosis. Postoperative chemotherapy begins within 6 weeks after surgery, comprising leucovorin calcium and fluorouracil IV on days 1-5. Treatment repeats every 21 days for 4 courses.
- interventionNames
- Drug: fluorouracil
- Drug: oxaliplatin
- Radiation: radiation therapy
- Drug: leucovorin calcium
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- MTD of oxaliplatin when combined with radiation therapy and fluorouracil based on the incidence of DLT as assessed by CTC version 2.0
- timeFrame
- 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, locally advanced, non-metastatic primary T3 or T4 primary adenocarcinoma of the rectum * No evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy * No intra-operative radiotherapy (IORT) or brachytherapy will be allowed * The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of anal verge by proctoscopic examination * Transmural penetration of tumor through the muscularis propria must be demonstrated by either of the following: * CT scan plus endorectal ultrasound or * MRI * Tumors must be defined prospectively by the surgeon as clinically resectable or not; clinically resectable tumors will be defined by the surgeon as mobile and completely resectable with negative margins based on the routine examination of the non-anesthetized patient; before pre-op treatment, the surgeon should estimate and record the type of resection anticipated: APR, LAR, or LAR/coloanal anastomosis * The tumor may be clinically fixed or initially not completely resectable, clinical stage T4, N0-2, M0 based on the presence of at least one of the following criteria: * Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum * Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane will be considered evidence of fixation * Hydronephrosis on CT scan or IVP or ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, or invasion into prostate * Vaginal or uterine involvement * ECOG performance status 0-2 and surgical evaluation confirms the patient's medical condition would tolerate the proposed surgical procedure * Caloric intake should be \>= 1500 kilocalories/d * WBC \>= 3500/uL * Platelets \>= 100,000/uL * Serum creatinine =\< 2.0 mg/dL * Serum bilirubin less than 2.0 mg/dL * Alk Phos =\< 2 x ULN * SGOT =\< 2 x ULN * CEA should be determined prior to initiation of therapy * Absence of clinical evidence of high-grade (lumen diameter \< 1cm) large bowel obstruction, unless diverting colostomy has been performed * Pregnant or lactating women are not eligible * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception * No prior chemotherapy or pelvic irradiation therapy * No previous or concurrent malignancy is allowed, except: * Nonmelanoma skin cancer or in situ cervical cancer * Treated non-pelvic cancer from which the patient has been continuously disease free more than five years * No active inflammatory bowel disease or other serious medical illness which might limit the ability of the patient to receive protocol therapy
References
Publications (0)
Data not yet available
No reference posted for this study.